dimecres, 7 de desembre del 2016

FDA releases November 2016 510(k) clearances

FDA logo510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2016


TOTAL 510(k)s THIS PERIOD   254                                     
TOTAL WITH SUMMARIES        241                                     
TOTAL WITH STATEMENTS        13


DEVICE: Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated    510(k) NO: K152232(Traditional)
ATTN: Lisa  Christo               PHONE NO : 913 5771784 
10101 Renner Blvd.                SE DECISION MADE: 18-NOV-16
Lenexa KS  66219-9275             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vonflex S
VERICOM CO., LTD.                 510(k) NO: K152615(Traditional)
ATTN: Myung-Hwan  Oh              PHONE NO : 82 31 4412881 
48, Toegyegongdan 1-gil           SE DECISION MADE: 03-NOV-16
Chuncheon-Si,   KR 200-944        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYPNOSPAD
Somnics Inc.                      510(k) NO: K152660(Traditional)
ATTN: TSUNG-MIN  HSIEH            PHONE NO : 886 355 09623190 
5F , No.22, Sec. 2, Sheng Yi Road.SE DECISION MADE: 09-NOV-16
Hsinchu County  TW 30261          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable High Pressure Injector Syringe
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K152906(Traditional)
ATTN: Wu  Feng                    PHONE NO : 86 510 83771274 
NO. 215 XIGANG ROAD, DONGBEITANG  SE DECISION MADE: 22-NOV-16
WUXI   CN 214191                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter A310
AMEMO INC                         510(k) NO: K153021(Traditional)
ATTN: HUA  XIE                    PHONE NO : 510 5099680 
1154 CADILLAC COURT               SE DECISION MADE: 22-NOV-16
MILPITAS CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMASORBPLUS Resorbable Hemostatic Bone Putty
ORTHOCON, INC.                    510(k) NO: K153317(Traditional)
ATTN: HOWARD L. SCHRAYER          PHONE NO : 609 9249510 
1 BRIDGE STREET, SUITE 121        SE DECISION MADE: 30-NOV-16
IRVINGTON NY  10533               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
Diazyme Laboratories              510(k) NO: K153394(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 18-NOV-16
Poway CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
PROTECT U GUARD, LLC              510(k) NO: K153409(Abbreviated)
ATTN: Brent W. Laartz             PHONE NO : 813 8150530 
1840 MEASE DRIVE SUITE 319        SE DECISION MADE: 15-NOV-16
Safety Harbor FL  34695           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PathLoc-SI Joint Fusion System
L&K BIOMED Co., Ltd.              510(k) NO: K153656(Traditional)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 14-NOV-16
Giheung-gu, Yongin-si  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co 
Synergeyes, Inc.                  510(k) NO: K153714(Abbreviated)
ATTN: Karen   Kincade             PHONE NO : 760 4769410 
5927 PRIESTLY DR SUITE210         SE DECISION MADE: 15-NOV-16
CARLSBAD CA  92008                510(k) STATEMENT
                                                    

DEVICE: Disposal Lens Cleaning Sheath
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K153773(Traditional)
ATTN: TOSHIYUKI  NAKAJIMA         PHONE NO : 81 426 422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 22-NOV-16
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heyman Packing Applicator Set
VARIAN MEDICAL SYSTEMS, INC       510(k) NO: K160045(Traditional)
ATTN: PETER J. CORONADO           PHONE NO : 650 4246230 
3100 HANSEN WAY                   SE DECISION MADE: 17-NOV-16
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Charisma
Heraeus Kulzer, LLC (Mitsui Chemic510(k) NO: K160049(Traditional)
ATTN: Jamie  Cleveland            PHONE NO : 574 2995421 
4315 S. Lafayette Blvd            SE DECISION MADE: 15-NOV-16
South Bend IN  46614              510(k) STATEMENT
                                                    

DEVICE: rainbow Shine
GENOSS Co. Ltd.                   510(k) NO: K160079(Traditional)
ATTN: Byungsun  Kim               PHONE NO : 82 70 70988806 
1F Gyeonggi R&DB Center/226, 2F, GSE DECISION MADE: 10-NOV-16
Suwon-si  KR 443-270              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iCodeConnect
3B MEDICAL, INC.                  510(k) NO: K160127(Traditional)
ATTN: ALEX  LUCIO                 PHONE NO : 863 2266285 
799 Overlook Drive                SE DECISION MADE: 10-NOV-16
Winter Haven FL  33884            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
HAGER & MEISINGER GMBH            510(k) NO: K160132(Traditional)
ATTN: Melanie   May               PHONE NO : 49 02131 2012292 
HANSEMANNSTRASSE 10               SE DECISION MADE: 21-NOV-16
NEUSS  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABL90 FLEX PLUS
RADIOMETER MEDICAL APS            510(k) NO: K160153(Special)
ATTN: SOEREN   BOEGESTRAND        PHONE NO : 45 3 8273852 
AAKANDEVEJ 21                     SE DECISION MADE: 04-NOV-16
BROENSHOEJ  DK DK-2700            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-MIND trium 
DE GOTZEN S.R.L.                  510(k) NO: K160166(Abbreviated)
ATTN: Olivier   Balouka           PHONE NO : 39 0331 376760 
VIA ROMA, 45                      SE DECISION MADE: 15-NOV-16
OLGIATE OLONA,  IT 21057          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intermittent Pneumatic Compression system
DaeSung Maref Co., Ltd            510(k) NO: K160180(Special)
ATTN: Jae-wha  Lee                PHONE NO : 82 31 4597211 
298-24, Gongdan-ro                SE DECISION MADE: 03-NOV-16
Gunpo-si  KR 15809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunmed Control Syringes
Sunny Medical Device (Shenzhen) Co510(k) NO: K160190(Traditional)
ATTN: James Qi Zhang              PHONE NO : 949 2168838 
56 Lehigh Aisle                   SE DECISION MADE: 10-NOV-16
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSTAAR AdjusteR
SPINAL ACOUSTICS, LLC             510(k) NO: K160278(Traditional)
ATTN: ALBERT A. TORRENCE          PHONE NO : 724 7755200 
640 FOURTH STREET                 SE DECISION MADE: 04-NOV-16
BEAVER PA  15009                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Sphygmomanometer
Guangdong Biolight Meditech Co., L510(k) NO: K160349(Traditional)
ATTN: Liang  Jin                  PHONE NO : 
Innovation First Road, Technical ISE DECISION MADE: 03-NOV-16
Zhuhai  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
PRIMED MEDICAL PRODUCTS INC.      510(k) NO: K160361(Traditional)
ATTN: RICHARD  R  ROY             PHONE NO : 1 780 4977600 
3RD FLOOR, 1259-91 ST SW.         SE DECISION MADE: 04-NOV-16
EDMONTON  CA T6X1E9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K160421(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 02-NOV-16
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PleurX Peritoneal Catheter System
CareFusion                        510(k) NO: K160437(Traditional)
ATTN: Tamara  Brey                PHONE NO : 847 3629485 
75 North Fairway Drive            SE DECISION MADE: 03-NOV-16
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCP Bone Putty
BioStructures, LLC                510(k) NO: K160446(Traditional)
ATTN: John  Brunelle              PHONE NO : 949 5531717 
1201 Dove Street, Suite 470       SE DECISION MADE: 07-NOV-16
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Calprest NG
EUROSPITAL S.P.A.                 510(k) NO: K160447(Traditional)
ATTN: Claudia  Brandolin          PHONE NO : 39 040 89971 
VIA FLAVIA 122                    SE DECISION MADE: 10-NOV-16
TRIESTE  IT 34147                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivo 60
BREAS MEDICAL AB                  510(k) NO: K160481(Traditional)
ATTN: Albert   Cefalo             PHONE NO : 617 3566289 
FORETAGSVAGEN 1                   SE DECISION MADE: 09-NOV-16
MOLNLYCKE VASTRA GOTALANDS LAN  SE510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160508(Traditional)
ATTN: Lei   Chen                  PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACH HI-TESE DECISION MADE: 21-NOV-16
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyCHROM ESBL
HARDY DIAGNOSTICS                 510(k) NO: K160512(Traditional)
ATTN: ANDRE  HSIUNG               PHONE NO : 805 3462766 
1430 WEST MCCOU LANE              SE DECISION MADE: 15-NOV-16
SANTA MARIA CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K160530(Traditional)
ATTN: Mina  Cheng                 PHONE NO : 86 755 61120299 
4TH FL, BLDG A, YINGTAILONG INDUSTSE DECISION MADE: 28-NOV-16
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Greiner Holdex
GREINER BIO-ONE NA INC.           510(k) NO: K160532(Traditional)
ATTN: MANFRED  ABEL               PHONE NO : 704 2617823 
4238 CAPITAL DRIVE                SE DECISION MADE: 03-NOV-16
MONROE NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM
PEGA MEDICAL INC.                 510(k) NO: K160545(Traditional)
ATTN: Ariel  R.  Dujovne          PHONE NO : 1 450 6885144 
1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 23-NOV-16
LAVAL  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAPIDO HOLLOW-FIBRE DIALYZERS
BELLCO Srl                        510(k) NO: K160558(Traditional)
ATTN: Giuseppe  Tomasini          PHONE NO : 0039 0535 29323 
via Camurana 1                    SE DECISION MADE: 18-NOV-16
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boosting Catheter
QXMEDICAL, LLC                    510(k) NO: K160561(Traditional)
ATTN: FERNANDO   DI CAPRIO        PHONE NO : 651 8422050 
2820 PATTON ROAD                  SE DECISION MADE: 02-NOV-16
ROSEVILLE MN  55113               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TroClose1200
GORDIAN SURGICAL LTD.             510(k) NO: K160564(Traditional)
ATTN: ZVI  PEER                   PHONE NO : 972 72 2607079 
17TH TCHELET ST.                  SE DECISION MADE: 17-NOV-16
KARMIEL  IL 2161401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRWire Guide Wire
NANO4IMAGING GMBH                 510(k) NO: K160594(Traditional)
ATTN: CHRISTOPH R. MANEGOLD       PHONE NO : 49 241 56528261 
PAUWELSSTR. 17                    SE DECISION MADE: 22-NOV-16
AACHEN  DE 52074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
PMS Medikal Ambalaj Sanayi ve Tica510(k) NO: K160595(Traditional)
ATTN: Derya  Dikici               PHONE NO : 90 324 2387042 
Karaduvar Mah Serbest Bolge, 11 caSE DECISION MADE: 18-NOV-16
Mersin  TR 33020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ENFit Syringe
Medline Industries, Inc.          510(k) NO: K160642(Traditional)
ATTN: Stephanie  Blair            PHONE NO : 847 6433690 
One Medline Place                 SE DECISION MADE: 29-NOV-16
Mundelein IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorSens
CorSens Medical Ltd.              510(k) NO: K160656(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 3 6070306 
3 Azrieli Center Triangular Tower SE DECISION MADE: 21-NOV-16
Tel Aviv  IL 6702301              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
EVOLUTION SPINE, LLC              510(k) NO: K160663(Traditional)
ATTN: Ashton  Kouzbari            PHONE NO : 214 6828536 
4225 OFFICE PARKWAY               SE DECISION MADE: 16-NOV-16
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONTOUR NEXT ONE Blood Glucose Monitoring System
ASCENSIA DIABETES CARE            510(k) NO: K160682(Traditional)
ATTN: Roger  Sonnenburg           PHONE NO : 574 2563441 
430 S. BEIGER ST.                 SE DECISION MADE: 17-NOV-16
Mishawaka IN  46544               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
Y. JACOBS MEDICAL, INC            510(k) NO: K160705(Traditional)
ATTN: HUI JUN PARK                PHONE NO : 82 254 60715 
6F SANGKYUNG BLDG. 669 SEOLLEUNG-RSE DECISION MADE: 23-NOV-16
SEOUL  KR 135-830                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
COVIDIEN                          510(k) NO: K160718(Traditional)
ATTN: Timothy  Holwick            PHONE NO : 303 3052345 
6135 Gunbarrel Avenue             SE DECISION MADE: 14-NOV-16
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carriere Motion Clear Class II
ORTHO ORGANIZERS, INC.            510(k) NO: K160720(Traditional)
ATTN: COLLEEN  BOSWELL            PHONE NO : 760 4488730 
1822 ASTON AVENUE                 SE DECISION MADE: 28-NOV-16
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOLINE touchECG
CARDIOLINE S.p.A                  510(k) NO: K160746(Traditional)
ATTN: Emanuele  Ercoli            PHONE NO : 039 0463 850125 
VIA LINZ 19-20-21                 SE DECISION MADE: 02-NOV-16
Z.I. SPINI DI GARDOLO  IT 38121   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DW-1C
DONGWON MEDICAL CO., LTD.         510(k) NO: K160761(Traditional)
ATTN: Gil  Haeng Lee              PHONE NO : 82 624 306521 
201-HO, 35, SAAM-RO 340BEON-GIL GWSE DECISION MADE: 22-NOV-16
Gwangju  KR 62328                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
DIAZYME LABORATORIES              510(k) NO: K160762(Traditional)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 4554762 
12889 GREGG COURT                 SE DECISION MADE: 21-NOV-16
POWAY CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RODO Abutment System
RODO MEDICAL, INC                 510(k) NO: K160786(Traditional)
ATTN: Michael   Parsons           PHONE NO : 408 2457636 
690 SARATOGA AVE., SUITE 100      SE DECISION MADE: 21-NOV-16
SAN JOSE CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmorChem Titanium Porous Fixation Device
AmorChem Holdings, Inc.           510(k) NO: K160791(Traditional)
ATTN: KEVIN  MCBRIDE              PHONE NO : 514 8495451 
1, Westmount Square               SE DECISION MADE: 15-NOV-16
Montreal  CA H3Z 2P9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DuoCem
COLTENE/WHALEDENT AG              510(k) NO: K160800(Traditional)
ATTN: Silke   Wallaschek          PHONE NO : 0041 71 7575852 
FELDWIESENSTR. 20                 SE DECISION MADE: 16-NOV-16
ALTSTATTEN  CH 9450               510(k) STATEMENT
                                                    

DEVICE: Well Lead Extraction Bag
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K160801(Traditional)
ATTN: HAN GUANG YUAN              PHONE NO : 86 20 84758878 
C-4 # JINHU INDUSTRIAL ESTATE, HUASE DECISION MADE: 29-NOV-16
GUANGZHOU  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U&U Enteral Syringe
U&U MEDICAL TECHNOLOGY CO.,LTD    510(k) NO: K160855(Traditional)
ATTN: BLACK   WANG                PHONE NO : 0086 1390 2471751 
DONGZHOU VILLAGE, HENGYSHANQIAO   SE DECISION MADE: 22-NOV-16
CHANGZHOU   CN 213119             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PolyPlex Wound Dressing
GLOBAL HEALTH SOLUTIONS, LLC      510(k) NO: K160872(Traditional)
ATTN: Bradley   Burnam            PHONE NO : 706 8441025 
1360 REDMOND CIRCLE               SE DECISION MADE: 23-NOV-16
Rome GA  30165                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tablo Console
OUTSET MEDICAL, INC.              510(k) NO: K160881(Traditional)
ATTN: LESLIE  TRIGG               PHONE NO : 650 2694483 
1830 BERING DRIVE                 SE DECISION MADE: 15-NOV-16
SAN JOSE CA  95112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CXI Support Catheter
COOK INCORPORATED                 510(k) NO: K160884(Special)
ATTN: Daniel J. Corbin            PHONE NO : 812 3392235 104018
750 DANIELS WAY                   SE DECISION MADE: 22-NOV-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Initia Total Hip System & BIOCERAM AZUL(R) HEAD
KYOCERA Medical Corporation       510(k) NO: K160895(Traditional)
ATTN: Cheryl  Hastings            PHONE NO : 574 5274220 
Uemura Nissei Bldg., 3-3-31 MiyahaSE DECISION MADE: 01-NOV-16
Yodogawa-ku  JP 532-0003          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
CS Medical LLC                    510(k) NO: K160921(Traditional)
ATTN: Kendall  Ashe               PHONE NO : 919 2559472 
2179 East Lyon Station Road       SE DECISION MADE: 03-NOV-16
Creedmoor NC  27522               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Anteverted Cemented Liner
SMITH & NEPHEW, INC.              510(k) NO: K160923(Traditional)
ATTN: KIM  PHAN                   PHONE NO : 901 8003175 
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 17-NOV-16
CORDOVA TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amendia Interbody Fusion Devices
AMENDIA, INC.                     510(k) NO: K160924(Traditional)
ATTN: Bruce   Hooper              PHONE NO : 877 7553329 
1755 WEST OAK PARKWAY             SE DECISION MADE: 08-NOV-16
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery NM 750b Bopsy
GE Healthcare                     510(k) NO: K160933(Traditional)
ATTN: Efrat  Hartog-David         PHONE NO : 972 4 8563666 805
4 Hayozma Street                  SE DECISION MADE: 18-NOV-16
Tirat Hacarmel  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Disposable Transflectance Forehead Sensor
Masimo Corporation                510(k) NO: K160940(Traditional)
ATTN: Marguerite  Thomlinson      PHONE NO : 949 2977000 
52 Discovery                      SE DECISION MADE: 23-NOV-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xsert Lumbar Expandable Interbody System
X-SPINE SYSTEMS, INC.             510(k) NO: K160959(Traditional)
ATTN: KRISS  ANDERSON             PHONE NO : 937 8478400 
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 17-NOV-16
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inclusive Abutments
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K160979(Traditional)
ATTN: SHELLY  HARRIS              PHONE NO : 949 4402629 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 04-NOV-16
IRVINE CA  92612                  510(k) STATEMENT
                                                    

DEVICE: SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
Adhezion Biomedical, LLC          510(k) NO: K161011(Traditional)
ATTN: Richard  Jones              PHONE NO : 610 2417191 
One Meridian Boulevard, Suite 1B02SE DECISION MADE: 08-NOV-16
Wyomissing PA  19610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoSEAL Hemostatic Pad
InnoTherapy Inc.                  510(k) NO: K161013(Traditional)
ATTN: Moon Sue Lee                PHONE NO : 82 2 69591338 
Ace Hightechcity2,25, Seonyu-ro 13SE DECISION MADE: 29-NOV-16
Seoul  KR 07282                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell AmpliScan
Cadwell Industries, Inc.          510(k) NO: K161027(Traditional)
ATTN: John  Cadwell               PHONE NO : 509 7356481 
909 N. Kellog St.                 SE DECISION MADE: 08-NOV-16
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
SHEN WEI (USA), INC.              510(k) NO: K161074(Traditional)
ATTN: CHERYL  BAILEY-KROLL        PHONE NO : 510 4298692 
33278 CENTRAL AVE., SUITE 102     SE DECISION MADE: 17-NOV-16
UNION CITY CA  94587              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FONA Pan/Ceph
FONA SRL                          510(k) NO: K161131(Traditional)
ATTN: ELISA  GUSBERTI             PHONE NO : 39 02 45712171 
VIA GALILEO GALILEI 11            SE DECISION MADE: 03-NOV-16
ASSAGO  IT 20090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea CT Dual Energy Image View
VITAL IMAGES, INC.                510(k) NO: K161157(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 952 4879774 
5850 OPUS PARKWAY SITE 300        SE DECISION MADE: 03-NOV-16
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova Interference Screw
NANOVA BIOMATERIALS INC.          510(k) NO: K161174(Traditional)
ATTN: ANDREW  RITTS               PHONE NO : 573 8756682 
3806 MOJAVE CT                    SE DECISION MADE: 03-NOV-16
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovo Life Small Bone IM Nail System
Renovo Life LLC                   510(k) NO: K161254(Traditional)
ATTN: Harold  Crowder             PHONE NO : 704 2244136 
1104 Spruce Street                SE DECISION MADE: 07-NOV-16
Belmont NC  28012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRIGEN Low Profile Bone Screws
SMITH & NEPHEW, INC.              510(k) NO: K161264(Special)
ATTN: ALLISON  CHAN               PHONE NO : 901 3991098 
1450 E. BROOKS ROAD               SE DECISION MADE: 23-NOV-16
MEMPHIS TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConvertX Nephroureteral Stent System
BRIGHTWATER MEDICAL               510(k) NO: K161277(Traditional)
ATTN: BOB  SMOUSE                 PHONE NO : 1 650 2108100 
816 W. BENNETT CT.                SE DECISION MADE: 22-NOV-16
DUNLAP IL  61525                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LenSX Laser System
ALCON LABORATORIES, INC.          510(k) NO: K161288(Traditional)
ATTN: JAMES  ARGANDA              PHONE NO : 949 5057038 
20511 LAKE FOREST DR              SE DECISION MADE: 16-NOV-16
LAKE FOREST CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solution Set for Epidural Use
BAXTER HEALTHCARE CORPORATION     510(k) NO: K161323(Third Party - Traditional)
ATTN: Tiffany   Lin               PHONE NO : 224 2704343 
32650 N. WILSON ROAD              SE DECISION MADE: 30-NOV-16
ROUND LAKE IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LipiFlow Thermal Pulsation System
TEARSCIENCE, INC.                 510(k) NO: K161357(Special)
ATTN: Christy   Coleman           PHONE NO : 919 4594815 
5151 MCCRIMMON PARKWAY SUITE 250  SE DECISION MADE: 04-NOV-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Durepair Dura Regeneration Matrix
Medtronic Neurosurgery            510(k) NO: K161370(Traditional)
ATTN: Manas  Lele                 PHONE NO : 805 5718956 
125 Cremona Drive                 SE DECISION MADE: 02-NOV-16
Goleta CA  93117                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nunchaku
FCI (FRANCE CHIRURGIE INSTRUMENTAT510(k) NO: K161373(Traditional)
ATTN: THIERRY  FETICK             PHONE NO : 33 153 989898 
20-22 RUE LOUIS ARMAND            SE DECISION MADE: 03-NOV-16
PARIS  FR 75015                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: joimax Electrosurgical Instruments
JOIMAX GMBH                       510(k) NO: K161378(Traditional)
ATTN: WOLFGANG  RIES              PHONE NO : 49 072 1255140 
AMALIENBADSTR. 41 RAUMFABRIK 61   SE DECISION MADE: 02-NOV-16
KARLSRUHE  DE 76227               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
ALCON LABORATORIES, INC.          510(k) NO: K161391(Traditional)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 SOUTH FREEWAY                SE DECISION MADE: 30-NOV-16
FORT WORTH TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compass Cast and MAP
CENTURION MEDICAL PRODUCTS CORPORA510(k) NO: K161408(Traditional)
ATTN: MATTHEW K. PRICE            PHONE NO : 517 5465400 1135
100 CENTURION WAY                 SE DECISION MADE: 22-NOV-16
WILLIAMSTON MI  48895             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes MAXFRAME Multi-Axial Correction System
SYNTHES USA, LLC                  510(k) NO: K161417(Traditional)
ATTN: STACEY  BONNELL             PHONE NO : 610 7195895 
1301 GOSHEN PARKWAY               SE DECISION MADE: 10-NOV-16
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimplECG
Nanowear Inc.                     510(k) NO: K161431(Traditional)
ATTN: Venkatesh  Varadan          PHONE NO : 718 6374815 
53 Boerum Place Suite 3F          SE DECISION MADE: 30-NOV-16
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulia Diabetes Management Companion
VOLUNTIS S.A.                     510(k) NO: K161433(Traditional)
ATTN: RAFFI  KRIKORIAN            PHONE NO : 33 141 383920 
58, AVENUE DE WAGRAM              SE DECISION MADE: 09-NOV-16
Paris  FR 75017                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Temporary Snap Abutment
Nobel Biocare AB                  510(k) NO: K161435(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
GENESYS SPINE                     510(k) NO: K161438(Traditional)
ATTN: BRIAN  BERGERON             PHONE NO : 512 3817071 
1250 CAPITAL OF TEXAS OF HIGHWAY SSE DECISION MADE: 08-NOV-16
AUSTIN TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Propeller Sensor Model 2015-E
Reciprocal Labs Corporation       510(k) NO: K161454(Traditional)
ATTN: Taylor  Mahan-Rudolph       PHONE NO : 608 2510470 
634 W. Main Street, Suite 102     SE DECISION MADE: 01-NOV-16
Madison WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XEN Glaucoma Treatment System
Allergan, Inc.                    510(k) NO: K161457(Traditional)
ATTN: Barbara A. Niksch           PHONE NO : 949 4500250 236
26970 Aliso Viejo Parkway, Suite 2SE DECISION MADE: 21-NOV-16
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Walk-O2-Bout
ESSEX INDUSTRIES, INC.            510(k) NO: K161472(Traditional)
ATTN: RUSS  JACOBSMEYER           PHONE NO : 314 3388723 
7700 GRAVOIS                      SE DECISION MADE: 18-NOV-16
ST. LOUIS MO  63123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YO Home Sperm Test
MEDICAL ELECTRONIC SYSTEMS, LTD   510(k) NO: K161493(Traditional)
ATTN: MARCIA   DEUTSCH            PHONE NO : 972 463 73981 
ALON HATAVOR ST.20  ZONE 6        SE DECISION MADE: 08-NOV-16
CAESAREA IND. PARK  IL 38900      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
Siemens Healthcare Diagnostics, In510(k) NO: K161494(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 302 6317654 
500 GBC Drive, PO Box 6101 MS 514 SE DECISION MADE: 15-NOV-16
Newark DE  19711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eUnity
Client Outlook Inc.               510(k) NO: K161515(Special)
ATTN: Christie  Eby               PHONE NO : 519 3423049 206
103 Bauer Place, Suite #3         SE DECISION MADE: 15-NOV-16
Waterloo  CA N2L6B5               510(k) STATEMENT
                                                    

DEVICE: MatrixRIB Fixation System
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K161590(Traditional)
ATTN: THOMAS  SHEA                PHONE NO : 610 7195679 
1301 GOSHEN PARKWAY               SE DECISION MADE: 03-NOV-16
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persona Partial Knee System
BIOMET, INC.                      510(k) NO: K161592(Traditional)
ATTN: Nicole  J.  Meredith        PHONE NO : 574 3773718 
56 EAST BELL DR.                  SE DECISION MADE: 03-NOV-16
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical BioTy® Nanotopography Trauma Screw
TYBER MEDICAL LLC                 510(k) NO: K161597(Traditional)
ATTN: MARK F. SCHENK              PHONE NO : 610 84906045 
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 16-NOV-16
MORRISTOWN NJ  07960              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPRT Revision Hip System
Encore Medical, L.P.              510(k) NO: K161610(Traditional)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 8346255 
9800 METIRC BLVD                  SE DECISION MADE: 09-NOV-16
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomical Shoulder Domelock Dome centric
ZIMMER GMBH                       510(k) NO: K161620(Traditional)
ATTN: ROBERTO  TOMMASINI          PHONE NO : 41 58 8548264 
SULZERALLEE 8                     SE DECISION MADE: 01-NOV-16
WINTERTHUR  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
B. Braun Medical Inc.             510(k) NO: K161623(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 610 2664962___ 
901 Marcon Blvd                   SE DECISION MADE: 10-NOV-16
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicrO2 OSA Device with Micro-Recorder
MICRODENTAL, Inc.                 510(k) NO: K161624(Traditional)
ATTN: David  Kuhns                PHONE NO : 925 8038643 
5601 Arnold Rd.                   SE DECISION MADE: 07-NOV-16
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAS Pulse(TM) Ultrasonic Therapy
Bonutti Research, Inc.            510(k) NO: K161628(Abbreviated)
ATTN: Patrick G. Balsmann         PHONE NO : 217 3423412 5106
P.O. Box 1367                     SE DECISION MADE: 10-NOV-16
Effingham IL  62401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPS CaseDesigner
NOBEL BIOCARE AB                  510(k) NO: K161634(Traditional)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 2824800 7830
VASTRA HAMNGATAN 1                SE DECISION MADE: 10-NOV-16
GOTEBORG  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lipogems System
Lipogems International SpA        510(k) NO: K161636(Traditional)
ATTN: CARLO  RUSSO                PHONE NO : 39 02 37072408 
viale Bianca Maria 24             SE DECISION MADE: 04-NOV-16
Milano  IT 20129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPEEDTRAP Graft Preparation System
MEDOS INTERNATIONAL SARL          510(k) NO: K161638(Traditional)
ATTN: Jeffrey  Dzialo             PHONE NO : 
CHEMIN-BLANC 38                   SE DECISION MADE: 07-NOV-16
LE LOCLE NEUCHATEL  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
DIAZYME LABORATORIES              510(k) NO: K161646(Traditional)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 4554762 
12889 GREGG COURT                 SE DECISION MADE: 04-NOV-16
POWAY CA  92130                   510(k) STATEMENT
                                                    

DEVICE: Virtu C Spinal Implant System
Met 1 Technologies, LLC           510(k) NO: K161649(Traditional)
ATTN: Dan  Gerbec                 PHONE NO : 915 3010834 
154 N. Festival Dr., Ste. F       SE DECISION MADE: 09-NOV-16
El Paso TX  79912                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VLP Wrist Fracture System
SMITH & NEPHEW, INC.              510(k) NO: K161665(Traditional)
ATTN: SAMANTHA  STAUBACH          PHONE NO : 901 3996132 
1450 BROOKS ROAD                  SE DECISION MADE: 15-NOV-16
MEMPHIS TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucid Q-PTP / HWA 55
BISON MEDICAL CO., LTD            510(k) NO: K161670(Traditional)
ATTN: SUN  WO                     PHONE NO : 82 286 57121 
ACE HIGH-END TOWER 6, 1801 BEOTKKOSE DECISION MADE: 02-NOV-16
GUEM CHEN GU  KR 153-789          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LacriPro Punctum Plug
LACRIMEDICS, INC.                 510(k) NO: K161673(Traditional)
ATTN: REBECCA C. DUTTON           PHONE NO : 253 9640360 
2620 WILLIAMSON PLACE NW, SUITE 11SE DECISION MADE: 18-NOV-16
DUPONT WA  98245                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Therapy Machine
BEIJING ADSS DEVELOPMENT CO., LTD 510(k) NO: K161692(Traditional)
ATTN: GAO  YURONG                 PHONE NO : 86 10 83625120 
F6, XIANDO BLDG., JINYUAN RD. 36, SE DECISION MADE: 16-NOV-16
BEIJING  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
AAP IMPLANTATE AG                 510(k) NO: K161696(Traditional)
ATTN: RENI  SCHALLER              PHONE NO : 49 307 50190 
LORENZWEG 5                       SE DECISION MADE: 23-NOV-16
BERLIN  DE 12099                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
STERILMED, INC.                   510(k) NO: K161700(Traditional)
ATTN: Reuben  Lawson              PHONE NO : 949 7898545 
5010 CHESHIRE PARKWAY STE. 2      SE DECISION MADE: 21-NOV-16
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
AAP IMPLANTATE AG                 510(k) NO: K161703(Traditional)
ATTN: RENI  SCHALLER              PHONE NO : 49 307 50190 
LORENZWEG 5                       SE DECISION MADE: 04-NOV-16
BERLIN  DE 12099                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K161708(Special)
ATTN: XIE  QIONGYU                PHONE NO : 086 0755 26710795 
2/F, M-7 SINOSTEEL BUILDING, MAQUESE DECISION MADE: 22-NOV-16
NANSHAN DISTRICT, SHENZHEN  CN 518510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Forehead Thermometer
Shenzhen Dongdixin Technology Co.,510(k) NO: K161735(Traditional)
ATTN: Siping  Yuan                PHONE NO : 086 075 527652471 
No. 3 Building Xilibaimang XushengSE DECISION MADE: 17-NOV-16
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K161738(Traditional)
ATTN: PAUL  LIU                   PHONE NO : 886 2 66258188 
6F, NO.127, WUGONG 2ND RD., WUGU DSE DECISION MADE: 10-NOV-16
NEW TAIPEI CITY  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-SPECT Scanner, D-SPECT L Scanner
Spectrum Dynamics Medical Ltd     510(k) NO: K161740(Traditional)
ATTN: Igor  Naroditsky            PHONE NO : 972 54 4384386 
22 Bareket St                     SE DECISION MADE: 04-NOV-16
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Tornier, Inc.                     510(k) NO: K161742(Traditional)
ATTN: Laurie  Lewandowski         PHONE NO : 612 7704038 
10801 Nesbitt Avenue South        SE DECISION MADE: 15-NOV-16
Bloomington MN  55340             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
aap Implantate AG                 510(k) NO: K161747(Traditional)
ATTN: Reni  Schaller              PHONE NO : 0049 30 75019193 
Lorenzweg 5                       SE DECISION MADE: 22-NOV-16
Berlin  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoffman LRF System
STRYKER GMBH                      510(k) NO: K161753(Traditional)
ATTN: PAUL  NELSON                PHONE NO : 201 8315691 
325 CORPORATE DRIVE               SE DECISION MADE: 15-NOV-16
MAHWAH NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
Smith & Nephew, Inc.              510(k) NO: K161763(Traditional)
ATTN: Bradley  Heil               PHONE NO : 901 3996339 
150 Minuteman Rd.                 SE DECISION MADE: 22-NOV-16
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUCAS 3 Chest Compression System
Jolife AB                         510(k) NO: K161768(Traditional)
ATTN: Malin  Melander             PHONE NO : 46 46 2865000 
Scheelevagen 17, Ideon Science ParSE DECISION MADE: 09-NOV-16
Lund  SE 223 70                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lenstec LC Injection system
LENSTEC INC.                      510(k) NO: K161776(Traditional)
ATTN: JIMMY  CHACKO               PHONE NO : 727 5712272 
1765 COMMERCE AVE.N.              SE DECISION MADE: 29-NOV-16
ST. PETERSBURG FL  33716          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToeTac™ 10° Hammertoe Fixation System
RESTORE SURGICAL LLC DBA INSTRATEK510(k) NO: K161778(Traditional)
ATTN: JEFF  SEAVEY                PHONE NO : 281 8908020 
15200 MIDDLEBROOK DR., SUITE G    SE DECISION MADE: 22-NOV-16
HOUSTON TX  77058                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
MedSource International, LLC      510(k) NO: K161779(Traditional)
ATTN: Laura  Riggen               PHONE NO : 952 2418325 
401 Norex Drive                   SE DECISION MADE: 03-NOV-16
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Revers Shoulder Prosthesis System
ARTHREX, INC.                     510(k) NO: K161782(Traditional)
ATTN: David L Rogers              PHONE NO : 239 6435553 71924
1370 CREEKSIDE BLVD.              SE DECISION MADE: 21-NOV-16
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc510(k) NO: K161795(Special)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway          SE DECISION MADE: 18-NOV-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NNR06 Multi-Purpose Solution
Bausch & Lomb Incorporated        510(k) NO: K161819(Traditional)
ATTN: Glenn  Davies               PHONE NO : 585 3388215 
1400 North Goodman Street         SE DECISION MADE: 25-NOV-16
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
Immunodiagnostic Systems Ltd      510(k) NO: K161831(Traditional)
ATTN: Mick  Henderson             PHONE NO : 440 191 5190660 
10 Didcot Way, Boldon Business ParSE DECISION MADE: 15-NOV-16
Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Drop Blood Glucose Monitoring System
AgaMatrix, Inc.                   510(k) NO: K161834(Special)
ATTN: David  Olsen                PHONE NO : 603 8934191 
7C Raymond Ave.                   SE DECISION MADE: 30-NOV-16
Salem NH  03079                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation       510(k) NO: K161856(Special)
ATTN: Paul W. MacDonald           PHONE NO : 781 6473700 
200 Prospect Street               SE DECISION MADE: 15-NOV-16
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermoPro
Zimmer MedizinSysteme GmbH        510(k) NO: K161862(Traditional)
ATTN: Armin  Petraschka           PHONE NO : 49 731 9761140 
Junkersstrasse 9                  SE DECISION MADE: 14-NOV-16
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
Stryker GmbH                      510(k) NO: K161863(Traditional)
ATTN: Saad  Attiyah               PHONE NO : 201 8315655 
Bohnackerweg 1                    SE DECISION MADE: 23-NOV-16
2545 Selzach  CH CH 2545          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pacel Flow Directed Pacing Catheter
St. Jude Medical                  510(k) NO: K161873(Traditional)
ATTN: Blair  Schwartz             PHONE NO : 651 7562706 
14901 DeVeau Place                SE DECISION MADE: 22-NOV-16
Minnetonka MN  55345              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HC Primer
Shofu Dental Corporation          510(k) NO: K161891(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 21-NOV-16
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
CHANGZHOU XIN NENG YUAN MEDICAL ST510(k) NO: K161905(Traditional)
ATTN: Boping  Ma                  PHONE NO : 86 519 88830515 
NO.51, SHUISHAN RD, ZHONGLOU ECONOSE DECISION MADE: 17-NOV-16
Changzhou  CN 213023              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQvitals Zone
Midmark Corporation               510(k) NO: K161909(Traditional)
ATTN: Asad  Abu-Tarif             PHONE NO : 800 6248950 
690 Knox Street, Suite 100        SE DECISION MADE: 17-NOV-16
Torrance CA  90502                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS Small Fragment Plating System
ADVANCED ORTHOPAEDIC  SOLUTIONS, I510(k) NO: K161913(Special)
ATTN: ALEX  BHASKARLA             PHONE NO : 310 5339966 
3203 KASHIWA STREET               SE DECISION MADE: 04-NOV-16
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SwiftNINJA Microcatheter
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K161921(Traditional)
ATTN: LUKE  MEIDELL               PHONE NO : 801 2084623 
1600 WEST MERIT PARKWAY           SE DECISION MADE: 04-NOV-16
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Terang Nusa Sdn Bhd               510(k) NO: K161932(Traditional)
ATTN: Robert  Hill                PHONE NO : 0060 977 47171 
1 Jalan 8, Pengkalan Chepa 2, InduSE DECISION MADE: 28-NOV-16
Kota Bharu  MY 16100              510(k) STATEMENT
                                                    

DEVICE: Avance Foam Dressing Kit - XL
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161935(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY,  SUITE 500SE DECISION MADE: 04-NOV-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Abdominal Dressing Kit
Molnlycke Health Care US, LLC     510(k) NO: K161939(Traditional)
ATTN: Megan  Bevill               PHONE NO : 470 3750049 
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 17-NOV-16
Norcross GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
SHANDONG BAISHENG MEDICAL PRODUCTS510(k) NO: K161944(Traditional)
ATTN: CECILY  SHENG               PHONE NO : 86 536 7510508 
11 Longshan Rd, Wolong Industy ParSE DECISION MADE: 21-NOV-16
Linqu  CN 262600                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Gauze Dressing Kits
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161948(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 03-NOV-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraShape System
Syneron Medical Ltd.              510(k) NO: K161952(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 73 2442200 
Tavor Building, Industrial Zone, PSE DECISION MADE: 07-NOV-16
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: W&H Implantmed SI-1015 incl. Accessories
W&H DENTALWERK BURMOOS GMBH       510(k) NO: K161957(Traditional)
ATTN: ANJA  LINDNER               PHONE NO : 0043 6274 6236397 
IGNAZ-GLASER-STRABE 53            SE DECISION MADE: 23-NOV-16
BUERMOOS  AT 5111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences LLC          510(k) NO: K161962(Traditional)
ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436 
One Edwards Way                   SE DECISION MADE: 28-NOV-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicrUs
TELEMED                           510(k) NO: K161968(Traditional)
ATTN: Yury  Sokolov               PHONE NO : 370 5 2106272 
Dariaus ir Gireno str.42          SE DECISION MADE: 03-NOV-16
Vilnius  LT LT-02189              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLENDERTONE® Connect Abs, Type 570
Bio-Medical Research Ltd.         510(k) NO: K161974(Special)
ATTN: Anne-Marie  Keenan          PHONE NO : 353 91 774316 
Parkmore Business Park West       SE DECISION MADE: 01-NOV-16
Galway  IE H91 NHT7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit N20
ResMed Ltd                        510(k) NO: K161978(Traditional)
ATTN: Kim Kuan Lee                PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 17-NOV-16
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leva® Anterior Interbody System
Spine Wave, Inc.                  510(k) NO: K161993(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 203 9449494 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 22-NOV-16
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer
SUPERSONIC IMAGINE                510(k) NO: K161999(Traditional)
ATTN: LAURENCE  HERMITTE          PHONE NO : 33 442 992424 
Les Jardins de La Duranne-bat E & SE DECISION MADE: 16-NOV-16
AIX-EN-PROVENCE  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
ZDi, Solutions, LLC               510(k) NO: K162002(Traditional)
ATTN: Zachary A. Dutton           PHONE NO : 865 8097283 
800 S Gay St, STE 714             SE DECISION MADE: 01-NOV-16
Knoxville TN  37909               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AltiVate Anatomic Shoulder System
ENCORE MEDICAL, L.P               510(k) NO: K162024(Traditional)
ATTN: DESIREE  WELLS              PHONE NO : 512 8346302 
9800 METRIC BLVD.                 SE DECISION MADE: 21-NOV-16
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelProcera HT ML FCZ Bridge
Nobel Biocare AB                  510(k) NO: K162043(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc            510(k) NO: K162050(Traditional)
ATTN: Shruti  Jayakumar           PHONE NO : 925 4742516 
4698 Willow Road                  SE DECISION MADE: 21-NOV-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
STRYKER CORPORATION               510(k) NO: K162062(Traditional)
ATTN: BECKY  DITTY                PHONE NO : 269 3893434 
4100 E MILHAM AVE                 SE DECISION MADE: 01-NOV-16
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Plating System
SMITH & NEPHEW, INC.              510(k) NO: K162078(Traditional)
ATTN: SAMANTHA  STAUBACH          PHONE NO : 901 3996132 
1450 BROOKS ROAD                  SE DECISION MADE: 18-NOV-16
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-CAT FLX V series / KaVo 3D eXam+ V series
IMAGING SCIENCES INTERNATIONAL    510(k) NO: K162085(Traditional)
ATTN: Ruth  Pui                   PHONE NO : 267 9541479 
1910 NORTH PENN RD.               SE DECISION MADE: 10-NOV-16
HATFIELD PA  19454                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evolv Model BP7000 Upper Arm Blood Pressure Monitor
OMRON HEALTHCARE, INC.            510(k) NO: K162092(Traditional)
ATTN: RENEE  THORNBOROUGH         PHONE NO : 847 2475626 
1925 WEST FIELD COURT             SE DECISION MADE: 22-NOV-16
LAKE FOREST IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
YTY INDUSTRY (MANJUNG) SDN. BHD., 510(k) NO: K162095(Traditional)
ATTN: Punitha  Samy               PHONE NO : 60 5 6792288 
Lot 1422-1424, Batu 10 Lekir      SE DECISION MADE: 02-NOV-16
Sitiawan  MY 32020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InTRAkit
Medtronic Vascular                510(k) NO: K162097(Traditional)
ATTN: Nisarg  Shah                PHONE NO : 978 7396632 
37A Cherry Hill Drive             SE DECISION MADE: 17-NOV-16
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Avantofit, MAGNETOM Skyrafit
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K162102(Traditional)
ATTN: JOHN  URTZ                  PHONE NO : 610 4486002 
40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 22-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
CHOICE SPINE, LP                  510(k) NO: K162103(Traditional)
ATTN: KIM  FINCH                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 23-NOV-16
KNOXVILLE TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue)
NAM VIET GLOVE JOINT STOCK COMPANY510(k) NO: K162113(Traditional)
ATTN: OOI LOON SENG               PHONE NO : 84 083 5147788 
HAMLET 7, PHUOC BINH COMMUNE LONG SE DECISION MADE: 07-NOV-16
HO CHI MINH  VN 815300            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
L&K BIOMED CO.,LTD.               510(k) NO: K162136(Traditional)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
GIHEUNG-GU, YONGIN-SI  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allura Xper R9
PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K162148(Abbreviated)
ATTN: Jeanette  Becker            PHONE NO : 31 611 621238 
VEENPLUIS 4-6                     SE DECISION MADE: 23-NOV-16
BEST  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xario 200 Diagnostic Ultrasound System V5.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162155(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 01-NOV-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Preference Elite Pedicle Screw System
AMEDICA CORPORATION               510(k) NO: K162160(Traditional)
ATTN: Shanna  Ryan                PHONE NO : 855 8393500 
1885 W 2100 S                     SE DECISION MADE: 18-NOV-16
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrier Supreme Sterilization Wrapper
Standard Textile Co., Inc.        510(k) NO: K162162(Traditional)
ATTN: Bradley J. Bushman          PHONE NO : 513 7619255 2455
One Knollcrest Drive              SE DECISION MADE: 04-NOV-16
Cincinnati OH  45237              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraShape System
SYNERON MEDICAL LTD               510(k) NO: K162163(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 732 442200 
TAVOR BUILDING, INDUSTRIAL ZONE, PSE DECISION MADE: 17-NOV-16
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Viet Glove Corporation            510(k) NO: K162175(Traditional)
ATTN: PHAM NGOC THANH             PHONE NO : 84 0650 591220 
Cau Sat Hamlet, Lai Hung Commune BSE DECISION MADE: 21-NOV-16
Bau Bang Province  VN             510(k) STATEMENT
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162183(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 25-NOV-16
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVILAS Laser System
OD-OS GMBH                        510(k) NO: K162191(Traditional)
ATTN: WINFRIED  TEIWES            PHONE NO : 49 3328 31282100 
14513 WARTHESTR. 21               SE DECISION MADE: 22-NOV-16
TELTOW  DE 14513                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GFS Ultimate
PARCUS MEDICAL, LLC               510(k) NO: K162198(Special)
ATTN: PAUL  VAGTS                 PHONE NO : 941 7557965 
6423 PARKLAND DR                  SE DECISION MADE: 18-NOV-16
SARASOTA FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: touchTymp
MAICO DIAGNOSTICS GMBH            510(k) NO: K162210(Special)
ATTN: UWE  LEDWORUSKI             PHONE NO : 49 307 0714661 
SICKINGENSTR. 70-71               SE DECISION MADE: 16-NOV-16
BERLIN  DE 10553                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuFit Lateral Plate System
PRECISION SPINE, INC.             510(k) NO: K162211(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 973 4557150 
5 SYLVAN WAY SUITE 220            SE DECISION MADE: 28-NOV-16
Parsippany NJ  07930              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protek Solo 24 Fr Venous Cannula Set
CARDIAC ASSIST, INC.              510(k) NO: K162214(Traditional)
ATTN: GREG  JOHNSON               PHONE NO : 412 9637770 
240 ALPHA DR.                     SE DECISION MADE: 30-NOV-16
PITTSBURGH PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
NUANCE MEDICAL, LLC               510(k) NO: K162218(Traditional)
ATTN: MARC  LIEBERMAN             PHONE NO : 760 5854849 
5931 Sea Lion Place, Suite 113    SE DECISION MADE: 22-NOV-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
DIO MEDICAL CO., LTD              510(k) NO: K162220(Traditional)
ATTN: SUNG  HEE-LEE               PHONE NO : 82 31 7763690 
101-105 MEGACENTER, SK TECHNOPARK,SE DECISION MADE: 21-NOV-16
SAGIMAKGOL-RO JUNGWON-GU SEONGNAM-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
WellDoc, Inc                      510(k) NO: K162225(Traditional)
ATTN: Michele  Livingston         PHONE NO : 443 6923100 
10221 Wincopin Circle Suite 150   SE DECISION MADE: 22-NOV-16
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ADON HEALTH CO., LTD.             510(k) NO: K162230(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 60526161 9060
NO.3 JIN PING ST, YA AN RD, NANKAISE DECISION MADE: 18-NOV-16
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
CYDEN LIMITED                     510(k) NO: K162231(Special)
ATTN: MIKE  KIERNAN               PHONE NO : 44 1792 485519 
TECHNIUM 2, KINGS ROAD            SE DECISION MADE: 16-NOV-16
SWANSEA  GB SA1 8PJ               510(k) STATEMENT
                                                    

DEVICE: MOSS 100 Pedicle Screw System
Biedermann Motech GmbH & Co. KG   510(k) NO: K162232(Traditional)
ATTN: Gerd  Federle               PHONE NO : 49 7720 8510545 
Bertha-von-Suttner-Straße 23      SE DECISION MADE: 17-NOV-16
Villingen-Schwenningen  DE 78054  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProMedTek Model C1400 Shortwave Diathermy Device
PROMEDTEK INC.                    510(k) NO: K162240(Traditional)
ATTN: Dan  Puchek                 PHONE NO : 480 3852488 
4110 N. SCOTTSDALE RD., SUITE 270 SE DECISION MADE: 17-NOV-16
Scottsdale AZ  85251              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FasTouch Fixation System
VIA SURGICAL LTD.                 510(k) NO: K162252(Special)
ATTN: OFEK  LEVIN                 PHONE NO : 972 52 6395765 
MITZPE KINERET STREET 22/1        SE DECISION MADE: 14-NOV-16
MOSHAV AMIRIM  IL 20115           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P1145 Dental Restorative
Kerr Corporation                  510(k) NO: K162257(Traditional)
ATTN: Mohammad Saad Ansari        PHONE NO : 909 9625644 
1717 W. Collins Ave               SE DECISION MADE: 07-NOV-16
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium® PL Cage
STRYKER                           510(k) NO: K162262(Traditional)
ATTN: Deirdre  Jayko              PHONE NO : 201 7498339 
2 Pearl Court                     SE DECISION MADE: 09-NOV-16
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CushionCast Moldable Cushions
IZI Medical Products LLC          510(k) NO: K162265(Traditional)
ATTN: Qiang  Cao                  PHONE NO : 443 8262997 
5 Easter Court Suite J            SE DECISION MADE: 15-NOV-16
Owings Mills MD  21117            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senographe Pristina
GE HEALTHCARE                     510(k) NO: K162268(Traditional)
ATTN: Gregory  Pessato            PHONE NO : 33 1 30709316 
283 RUE DE LA MINIERE             SE DECISION MADE: 03-NOV-16
BUC  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise TKA Guide System
MATERIALISE NV                    510(k) NO: K162273(Traditional)
ATTN: OLIVER  CLEMENS             PHONE NO : 32 163 96280 
TECHNOLOGIELAAN 15                SE DECISION MADE: 07-NOV-16
LEUVEN  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Diagnostic Mobile X-ray System
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K162278(Traditional)
ATTN: CHULSIN  KIM                PHONE NO : 82 312 007661 
129, SAMSUNG-RO, YEONGTONG-GU     SE DECISION MADE: 15-NOV-16
SUWON-SI  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Fecal Opti-Swab Collection and Transport System
PURITAN MEDICAL PRODUCTS LLC      510(k) NO: K162284(Traditional)
ATTN: MEHDI  KARAMCHI             PHONE NO : 207 8763311 3284
31 SCHOOL STREET P.O. BOX 149     SE DECISION MADE: 04-NOV-16
GUILFORD ME  04443                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reform® POCT System
PRECISION SPINE, INC.             510(k) NO: K162300(Traditional)
ATTN: MICHAEL C. DAWSON           PHONE NO : 601 4204244 
2050 EXECUTIVE DRIVE              SE DECISION MADE: 22-NOV-16
PEARL MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XBraid TT Suture Tape
Stryker                           510(k) NO: K162310(Traditional)
ATTN: Taylor  White               PHONE NO : 303 3367285 
5670 Greenwood Plaza Blvd., Suite SE DECISION MADE: 10-NOV-16
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pirouette 014
ArraVasc Ltd                      510(k) NO: K162316(Special)
ATTN: Aoife  Donoghue             PHONE NO : 353 91 758939 54
2 Ballybrit Business Park         SE DECISION MADE: 22-NOV-16
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
ACCESS SCIENTIFIC, LLC            510(k) NO: K162322(Traditional)
ATTN: WALTER  CORDIGLIA           PHONE NO : 1 858 4800216 
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 17-NOV-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018"
Boston Scientific Corporation     510(k) NO: K162350(Special)
ATTN: Ka Zoua Xiong               PHONE NO : 763 4942970 
One Scimed Place                  SE DECISION MADE: 04-NOV-16
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raycast MammoRx Carbon Fibre Breast Board
Orfit Industries NV               510(k) NO: K162355(Traditional)
ATTN: Eddy  Marivoet              PHONE NO : 32 0 33262026 
9A, VOSVELD                       SE DECISION MADE: 22-NOV-16
WIJNEGEM  BE 2110                 510(k) STATEMENT
                                                    

DEVICE: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
SYNTHES USA PRODUCTS LLC          510(k) NO: K162358(Traditional)
ATTN: Eugene  Bang                PHONE NO : 508 9773966 
325 Paramount Drive               SE DECISION MADE: 01-NOV-16
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V30 system, V-Form Handpiece BC Medium applicator
Viora Ltd.                        510(k) NO: K162363(Traditional)
ATTN: Stella Raizelman Perry      PHONE NO : 972 9 9551344 
6 Hagavish Street                 SE DECISION MADE: 18-NOV-16
Netanya  IL 4250706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K162379(Traditional)
ATTN: Nathaniel  Hendricks        PHONE NO : 901 3441208 
1800 Pyramid Place                SE DECISION MADE: 16-NOV-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILK Surgical Suture
TELEFLEX MEDICAL, INC             510(k) NO: K162396(Traditional)
ATTN: NATALIE  HICHAK             PHONE NO : 919 4338049 
3015 CARRINGTON MILL BLVD         SE DECISION MADE: 23-NOV-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyperBand
GE Medical Systems, LLC           510(k) NO: K162403(Traditional)
ATTN: Jason  Ma                   PHONE NO : 262 3522892 
3200 North Grandview Blvd         SE DECISION MADE: 18-NOV-16
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
BECKMAN COULTER, INC.             510(k) NO: K162414(Special)
ATTN: NANCY  NADLER               PHONE NO : 305 3804191 
11800 SW 147TH AVE.               SE DECISION MADE: 29-NOV-16
MIAMI FL  33196                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luna 3D Interbody Fusion System
Benvenue Medical, Inc.            510(k) NO: K162431(Traditional)
ATTN: Jeff  Emery                 PHONE NO : 408 4549300 
5403 Betsy Ross Drive             SE DECISION MADE: 17-NOV-16
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioInsight Cardiac Mapping System
CARDIOINSIGHT TECHNOLODIES, INC   510(k) NO: K162440(Special)
ATTN: LAURIE  LEWANDOWSKI         PHONE NO : 612 7704038 
11000 CEDAR AVE SUITE 210         SE DECISION MADE: 04-NOV-16
CLEVELAND OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert MRSA NxG
CEPHEID                           510(k) NO: K162444(Traditional)
ATTN: SCOTT A. CAMPBELL           PHONE NO : 847 2283299 
904 CARIBBEAN DRIVE               SE DECISION MADE: 23-NOV-16
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESPADA Acne-Clearing Blue Light Pen
FOREO INC.                        510(k) NO: K162450(Traditional)
ATTN: Davor  Soldo                PHONE NO : 855 7736736 
1525 Pama Lane, Suite 200         SE DECISION MADE: 30-NOV-16
Las Vegas NV  89119               510(k) STATEMENT
                                                    

DEVICE: Solana HSV 1+2/VZV Assay
QUIDEL CORPORATION                510(k) NO: K162451(Traditional)
ATTN: Ronald H. Lollar            PHONE NO : 740 5893373 
2005 EAST STATE STREET, SUITE 100 SE DECISION MADE: 28-NOV-16
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Pan Medical Ltd.                  510(k) NO: K162453(Special)
ATTN: Jennie  Budding             PHONE NO : 44 1452 621621 
Barnett Way, Barnwood             SE DECISION MADE: 01-NOV-16
Gloucester  GB GL4 3RT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Rocket Medical Plc                510(k) NO: K162457(Traditional)
ATTN: Tracy  Charlton             PHONE NO : 0044 191 4194488 222
2-4 Sedling Road, Wear Industrial SE DECISION MADE: 14-NOV-16
Washington  GB NE38 9BZ           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC            510(k) NO: K162462(Traditional)
ATTN: KIM  FORCH                  PHONE NO : 847 5507962 
THREE CORPORATE DRIVE             SE DECISION MADE: 23-NOV-16
LAKE ZURICH IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LuminScan (TM) Imaging System
MICRO-TECH (NANJING) CO.,LTD.     510(k) NO: K162466(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 GAOKE THIRD ROAD           SE DECISION MADE: 29-NOV-16
NANJING  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAD/CAMouflage Milling Block
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K162537(Special)
ATTN: ALIVA  DAS                  PHONE NO : 949 2251249 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 16-NOV-16
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K162538(Special)
ATTN: SUSAN  FERRIN               PHONE NO : 508 6604487 
333 CONEY STREET                  SE DECISION MADE: 17-NOV-16
E. WALPOLE MA  02032              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire 2 Revascularization Device
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K162539(Traditional)
ATTN: JENNIFER  CORREA            PHONE NO : 949 2979563 
9775 TOLEDO WAY                   SE DECISION MADE: 10-NOV-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162541(Traditional)
ATTN: PATRICIA D. JONES           PHONE NO : 610 4486474 
40 LIBERTY BOULEVARD 65-1A        SE DECISION MADE: 16-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
SOURCE PRODUCTION AND EQUIPMENT CO510(k) NO: K162573(Traditional)
ATTN: KELLEY  RICHARDT            PHONE NO : 504 4649471 
113 TEAL STREET                   SE DECISION MADE: 04-NOV-16
SAINT ROSE LA  70087              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTEZZA Spinal Stabilization System
OSSO SURGICAL                     510(k) NO: K162576(Traditional)
ATTN: Basheer  Hassan             PHONE NO : 875 5131774 
2150 W 43RD ST                    SE DECISION MADE: 10-NOV-16
Chicago IL  60609                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dosimetry Check Version 5 Release 1
MATH RESOLUTIONS, LLC             510(k) NO: K162577(Traditional)
ATTN: WENDEL DEAN RENNER          PHONE NO : 410 9979578 
5975 GALES LANE                   SE DECISION MADE: 18-NOV-16
COLUMBIA MD  21045                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALOKA LISENDO 880
HITACHI, LTD.                     510(k) NO: K162583(Traditional)
ATTN: ANGELA VAN ARSDALE          PHONE NO : 203 2695088 346
10 FAIRFIELD BLVD                 SE DECISION MADE: 17-NOV-16
WALLINGFORD CT  06492-5903        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuniIQ Digital Radiography System
Suni Medical Imaging, Inc         510(k) NO: K162585(Third Party - Traditional)
ATTN: Al  Bettencourt             PHONE NO : 408 3370573 
6840 Via Del Oro Suite 160        SE DECISION MADE: 04-NOV-16
San Jose CA  95119                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Trex_HD
Natus Medical Incorporated DBA Exc510(k) NO: K162595(Traditional)
ATTN: Sanjay  Mehta               PHONE NO : 905 8295300 
2568 Bristol Circle               SE DECISION MADE: 04-NOV-16
Oakville  CA L6H 5S1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I View and Imagen Sensor
TRIDENT S.R.L.                    510(k) NO: K162619(Traditional)
ATTN: GIORGIO  RIZZO              PHONE NO : 39 02 87072380 
VIA VERDI 20                      SE DECISION MADE: 04-NOV-16
ASSAGO  IT 20090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESU-1 Electrosurgical Generator
TVA Medical, Inc.                 510(k) NO: K162656(Traditional)
ATTN: Katherine  Kumar            PHONE NO : 612 7165578 
7000 Bee Caves Rd., Suite 250     SE DECISION MADE: 10-NOV-16
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViewPoint 6
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K162743(Traditional)
ATTN: TRACEY  ORTIZ               PHONE NO : 262 6766120 
9900 W INNOVATION DRIVE           SE DECISION MADE: 22-NOV-16
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinpoint GT Introducer Needle
C.R. BARD, INC.                   510(k) NO: K162769(Special)
ATTN: Jamie  Howell               PHONE NO : 801 5225465 
605 NORTH 5600 WEST               SE DECISION MADE: 04-NOV-16
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magma Spark
Formatk Systems Ltd.              510(k) NO: K162781(Special)
ATTN: Ahava  Stein                PHONE NO : 972 4 8571848 
3 Hayozma St.                     SE DECISION MADE: 09-NOV-16
Tirat Hacarmel  IL 3903203        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CastleLoc Spinal Fixation System
L&K BIOMED CO., LTD.              510(k) NO: K162801(Special)
ATTN: Yerim  An                   PHONE NO : 82 267 171985 
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
Giheung-gu, Yongin-si  KR 17015   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small (4") Roller Pump for the Terumo Advanced Perfusion System 1, Large (6") Roller Pump for the Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K162843(Special)
ATTN: Bryan  Hann                 PHONE NO : 734 7415816 
6200 Jackson Road                 SE DECISION MADE: 17-NOV-16
Ann Arbor MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raycast High Precision Lung Board Solution
Orfit Industries NV               510(k) NO: K162862(Third Party - Traditional)
ATTN: Raymond  Kelly              PHONE NO : 203 4007566 
9A VOSVELD                        SE DECISION MADE: 09-NOV-16
WIJNEGEM  BE 2110                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: dS Small Extremity 16CH 1.5T Coil
INVIVO THERAPEUTICS CORPORATION   510(k) NO: K162863(Third Party - Traditional)
ATTN: Ken  Revennaugh             PHONE NO : 352 3848590 
3545 SW 47th Ave                  SE DECISION MADE: 07-NOV-16
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Achieve Advance Mapping Catheter
MEDTRONIC INC.                    510(k) NO: K162892(Special)
ATTN: HEATHER  TAYLOR             PHONE NO : 763 5269066 
8200 CORAL SEA STREET NE MAIL STOPSE DECISION MADE: 15-NOV-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuCath Intravascular Catheter
C.R.BARD, INC.                    510(k) NO: K162894(Special)
ATTN: JACOB  LEE                  PHONE NO : 801 5225823 
605 N 5600 W                      SE DECISION MADE: 15-NOV-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.               510(k) NO: K162914(Special)
ATTN: Robin  Fuller               PHONE NO : 508 6587986 
26 Forest Street                  SE DECISION MADE: 16-NOV-16
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ligasure Blunt Tip, Sealer/Divider, Nano-coated
COVIDIEN                          510(k) NO: K162941(Special)
ATTN: CELSO  DURAN                PHONE NO : 303 5306445 
5920 LONGBOW DRIVE                SE DECISION MADE: 14-NOV-16
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Irix-C Cervical Integrated Fusion System
X-SPINE SYSTEMS, INC.             510(k) NO: K162944(Traditional)
ATTN: KRISS  ANDERSSON            PHONE NO : 937 8478400 2137
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 07-NOV-16
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TxRx Knee 15 Flare MR Coil 1.5T
Quality Electrodynamics, LLC      510(k) NO: K162966(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 Beta Drive Suite 100         SE DECISION MADE: 30-NOV-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
Inari Medical                     510(k) NO: K162970(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 22-NOV-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multix Fusion Max
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162971(Special)
ATTN: DENISE  ADAMS               PHONE NO : 610 4486139 
40 LIBERTY BOULEVARD, MAIL CODE 65SE DECISION MADE: 22-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR240amx
GE Medical Systems, LLC           510(k) NO: K162990(Special)
ATTN: Chris  Paulik               PHONE NO : 262 5482010 
3000 N. Grandview Blvd.           SE DECISION MADE: 15-NOV-16
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capillus302, Capillus312, Capillus352
CAPILLUS, LLC                     510(k) NO: K162994(Special)
ATTN: PATRICIA  SCHNOOR           PHONE NO : 786 8881874 
1715 NW 82nd AVE                  SE DECISION MADE: 18-NOV-16
MIAMI FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Microfixation SternaLock 360 Sternal Closure System
BIOMET MICROFIXATION              510(k) NO: K163007(Special)
ATTN: LAUREN  JASPER              PHONE NO : 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 23-NOV-16
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xperius Ultrasound System
PHILIPS HEALTHCARE                510(k) NO: K163020(Third Party - Traditional)
ATTN: SCOTT  ZHANG                PHONE NO : 425 4877000 
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 16-NOV-16
BOTHELL WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Zeramex P6 Dental Implant System
DENTALPOINT AG                    510(k) NO: K163043(Special)
ATTN: Viktor  Lienhard            PHONE NO : 41 44 3883636 
Hohlstrasse 614                   SE DECISION MADE: 30-NOV-16
Zurich  CH 8048                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TxRx Knee 15 Flare MR Coil 3.0T
QUALITY ELECTRODYNAMICS, LLC      510(k) NO: K163066(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 BETA DRIVE SUITE 100         SE DECISION MADE: 29-NOV-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ E9, LOGIQ E9 XDClear 2.0
GE Medical Systems Ultrasound and 510(k) NO: K163077(Special)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Dr.               SE DECISION MADE: 17-NOV-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TubeClear Control Box and Clearing Stem
Actuated Medical, Inc.            510(k) NO: K163092(Third Party - Traditional)
ATTN: Thomas L. Cronin            PHONE NO : 814 3550003 118
310 Rolling Ridge Drive           SE DECISION MADE: 30-NOV-16
Bellefonte PA  16801              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
COVIDIEN                          510(k) NO: K163102(Special)
ATTN: KATIE  BROWN                PHONE NO : 203 4928350 
60 MIDDLETON AVE.                 SE DECISION MADE: 30-NOV-16
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound System
Clarius Mobile Health Corp.       510(k) NO: K163138(Third Party - Abbreviated)
ATTN: Abhijit  Ahir               PHONE NO : 1 788 8009975 
350 - 3605 Gilmore Way            SE DECISION MADE: 30-NOV-16
Burnaby  CA V5G 4X5               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PleuraFlow System with FlowGlide
CLEARFLOW, INC.                   510(k) NO: K163139(Special)
ATTN: DOV  GAL                    PHONE NO : 714 9165014 
1630 S. SUNKIST ST. SUITE E       SE DECISION MADE: 30-NOV-16
ANAHEIM CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiLux LED Illuminator
ISOLUX LLC                        510(k) NO: K163185(Third Party - Traditional)
ATTN: NIKOLAOS  ANDREOULAKIS      PHONE NO : 239 5147475 
1045 COLLIER CENTER WAY SUITE #6  SE DECISION MADE: 21-NOV-16
NAPLES FL  34110                  510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Filtek One Bulk Fill Restorative
3M Company                        510(k) NO: K163207(Third Party - Traditional)
ATTN: Scott  Erickson             PHONE NO : 651 7369883 
2510 Conway Ave.                  SE DECISION MADE: 28-NOV-16
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

The post FDA releases November 2016 510(k) clearances appeared first on MassDevice.



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