| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K162375 |
12/29/2016 |
Envision 3D: Image Guidance System |
7D SURGICAL INC. |
DANIEL ZISKIND |
| K153330 |
02/19/2016 |
FreeStyle Precision Neo H Blood Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Arul Sterlin |
| K151185 |
02/05/2016 |
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) |
ABL Medical, LLC |
Robert Holladay |
| K153341 |
02/12/2016 |
Relieva Scout Multi-Sinus Dilation System |
ACCLARENT, INC. |
JAMES PATRICK GARVEY |
| K153718 |
02/12/2016 |
Spirit Hair Removal laser Family |
ACTIVE OPTICAL SYSTEMS , LTD. |
GIL Bidas |
| K162005 |
12/08/2016 |
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K153488 |
02/25/2016 |
Occlusion Perfusion Catheter |
Advanced Catheter Therapies, Inc. |
Paul Joseph Fitzpatrick |
| K160171 |
02/26/2016 |
Illuminated Mediastinal Access Port |
Aegis Surgical Ltd |
William Starling |
| K162134 |
12/14/2016 |
ENNOVATE Spinal System |
Aesculap Implant Systems, LLC |
Paul Amudala |
| K151165 |
02/17/2016 |
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture |
AESCULAP, INC. |
KATHY A. RACOSKY |
| K163000 |
12/23/2016 |
AMPLATZER TorqVue 45x45 Delivery Sheath |
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co |
Mary Johnson |
| DEN150055 |
12/21/2016 |
AeroForm Tissue Expander System |
AIRXPANDERS, INC |
Robin` Bush |
| K152420 |
12/01/2016 |
AK Body Toning Device |
AK BEAUTY ENTERPRISES, LLC |
Robert Applebaum |
| K151717 |
02/23/2016 |
twion |
Alber GmbH |
Bernd Engels |
| K163266 |
12/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| DEN150022 |
12/20/2016 |
Ultravision Visual Clearing System |
Alesi Surgical Ltd. |
DOMINIC GRIFFITHS |
| K162721 |
12/22/2016 |
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
ALLIQUA BIOMEDICAL, INC. |
KATHY SIMPSON |
| K153424 |
02/26/2016 |
E-CUBE i7 |
ALPINION MEDICAL SYSTEMS CO., LTD. |
Donghwan KIM |
| K152819 |
02/05/2016 |
Amecath Peripheral inserted Central Venous Catheter Sets |
AMECO MEDICAL INDUSTRIES |
Samy Hamboly |
| K160291 |
02/18/2016 |
Optimus ALIF System |
Amendia, Inc. |
Kristen Allen |
| K160014 |
02/02/2016 |
iHealth Track Blood Pressure Monitor |
Andon Health Co., Ltd |
Liu Yi |
| K161299 |
12/23/2016 |
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System |
APEX BIOTECHNOLOGY CORP. |
Hsue-mei Lee |
| K152160 |
02/23/2016 |
Navik 3D |
APN Health, LLC |
David Geddam |
| K151480 |
02/19/2016 |
Epix Electrosurgical Probe with Smoke Evacuation |
APPLIED MEDICAL RESOURCES |
FRANS VANDENBROEK |
| K162676 |
12/01/2016 |
Voyant Open Fusion Device |
Applied Medical Resources |
Jessica Cho |
| K153416 |
02/02/2016 |
ArcScan Insight 100 |
ARCSCAN, INC. |
Andy Levien |
| K160574 |
12/20/2016 |
K3PRO SURGICAL TRAY |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
RICHARD DONACA |
| K160785 |
12/08/2016 |
Worker Guidewire |
ARGON MEDICAL DEVICES, INC. |
SUZANNE CHEANG |
| K152555 |
02/11/2016 |
Dental Implant System |
AriaBio International Inc |
Hagai Jacobsen |
| K162461 |
12/20/2016 |
Endoform Plastics and Reconstructive Matrix |
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) |
Yasmin Rai |
| K160925 |
12/22/2016 |
VPS Rhythm Device with TipTracker Technology |
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) |
KARL J. NITTINGER |
| K153487 |
02/04/2016 |
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS |
ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.) |
Elizabeth Duncan |
| K153586 |
02/19/2016 |
Arthrex iBalance TKA System |
Arthrex, Inc. |
Leon Brown |
| K161060 |
12/15/2016 |
Arthrex iBalance UKA System Vitamin E Tibial Bearing |
Arthrex, Inc. |
David L Rogers |
| K151092 |
02/23/2016 |
Arthrex Short Suture Anchors |
Arthrex, Inc. |
David L Rogers |
| K153218 |
02/12/2016 |
Arthrex Synergy UHD4 System |
ARTHREX, INC. |
DAVID L ROGERS |
| K151311 |
02/10/2016 |
Safe Block Pen Needle |
Artsana S.P.A |
Cassani Mauro |
| K153443 |
02/25/2016 |
ASAHI Astato XS 40 |
ASAHI INTECC CO., LTD. |
YOSHIHIKO FUKUI |
| K152768 |
02/24/2016 |
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip |
ASSURE TECH. CO., LTD. |
ERIC LIN |
| K151404 |
02/12/2016 |
ProTrach Dualcare |
ATOS MEDICAL AB |
Ferenc Dahner |
| K152994 |
02/03/2016 |
Adaptivo |
Aurora Technology Development, LLC |
Gustavo H Olivera |
| K163264 |
12/21/2016 |
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled |
Avinger, Inc. |
Patty Hevey |
| K151772 |
02/09/2016 |
Actreen Mini Intermittent Urinary Catheters |
B. BRAUN MEDICAL INC. |
SIERRA M. MERTZ |
| K151423 |
02/19/2016 |
APEX Compounding System Transfer Set |
B. BRAUN MEDICAL INC. |
TRACY MADDOCK |
| K152765 |
02/26/2016 |
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM |
B.BRAUN INTERVENTIONAL SYSTEMS INC. |
PETER FLOSDORF |
| DEN150009 |
02/20/2016 |
B.R.A.H.M.S PCT sensitive KRYPTOR |
B.R.A.H.M.S GMBH |
BERNHARD CIOMMER |
| K151918 |
02/11/2016 |
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist |
BAUSCH & LOMB INCORPORATED |
Barbara Klube-Falso |
| K160007 |
12/19/2016 |
Paclitaxel Sets |
BAXTER HEALTHCARE CORPORATION |
Tiffany Lin |
| K151482 |
02/26/2016 |
BCR-30-min BIÖ and RBIP-ST30Ö Readout Accessory |
BCR DIAGNOSTICS, INC. |
BORIS ROTMAN |
| K161837 |
12/16/2016 |
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer |
BECKMAN COULTER INC. |
GERALDINE FUENTESPINA |
| K151866 |
02/25/2016 |
BD BACTEC Peds Plus/F Culture Vials (plastic) |
BECTON DICKINSON AND COMPANY |
ASHANTI C. BROWN |
| K160161 |
02/24/2016 |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
Becton, Dickinson & Co. |
Gregory P. Payne |
| K160164 |
02/25/2016 |
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit |
Becton, Dickinson & Co. |
Gregory P. Payne |
| K162081 |
12/19/2016 |
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe |
Becton, Dickinson and Company |
Murtaza Rana |
| K162516 |
12/09/2016 |
BD Pen Needle |
BECTON, DICKINSON AND COMPANY |
MERIAM YOUSSEF |
| K153309 |
02/12/2016 |
BD Vacutainer UltraTouch Push Button Blood Collection Set |
BECTON, DICKINSON AND COMPANY |
Pasquale Amato |
| K152898 |
02/09/2016 |
DIODE LASER THERAPY SYSTEMS |
BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD |
XIN WANG |
| K152324 |
02/01/2016 |
YAHUA Spinal System |
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. |
XINJIAN LV |
| K162180 |
12/29/2016 |
Disposable Insulin Syringe |
BERPU MEDICAL TECHNOLOGY CO., LTD |
JUNDONG TAN |
| K161844 |
12/13/2016 |
Matrix Pre-Treatment Controller |
BETTER WATER, LLC. |
MIKE CLINE |
| K153474 |
02/23/2016 |
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series |
BIOCHEMICAL DIAGNOSTICS, INC |
ALLEN PANETZ |
| K162373 |
12/16/2016 |
LC Bead LUMI |
Biocompatibles UK Limited |
Simon Leppard |
| K160068 |
02/08/2016 |
FilmArray Respiratory Panel (RP) for use with FilmArray Torch |
BioFire Diagnostics, LLC |
KRISTEN J. KANACK |
| K151955 |
02/05/2016 |
YuGo System |
BIOGAMING LTD. |
RONIT HARPAZ |
| K152185 |
02/11/2016 |
ARCHITECT SHBG |
BIOKIT, S.A. |
ANGELS ROMA |
| K151817 |
02/18/2016 |
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL |
BIOMERIEUX INC |
KAREN RUSSELL |
| K160854 |
12/19/2016 |
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture |
Biomet Manafacturing Corp. |
Adam Cargill |
| K153398 |
02/03/2016 |
Comprehensive SRS/Nexel Elbow |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K152868 |
02/08/2016 |
ExpressBraid Graft Manipulation |
BIOMET MANUFACTURING CORP. |
ADAM CARGILL |
| K162974 |
12/09/2016 |
Biomet Microfixation RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K162783 |
12/09/2016 |
EnFocus 2300, EnFocus 4400 |
Bioptigen, Inc. |
Ravi Kommineni |
| K161632 |
12/08/2016 |
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) |
BIOS S.R.L. |
Riccardo Pisati |
| K161704 |
12/01/2016 |
Phasor Drill |
BIOTEX, INC. |
RICHARD WAITE |
| K150492 |
02/19/2016 |
Ora-GUARD Dental Grind Guard |
Bite Tech Inc. |
Jeff Padovan |
| K162192 |
12/15/2016 |
BluePro |
BlueSom |
Erwan Floch |
| K152141 |
02/25/2016 |
High Pressure Tanning Lamps |
BLV Licht-und Vakuumtechnik GmbH |
Heinz-Jurgen Wesseling |
| K162205 |
12/09/2016 |
Arc EndoCuff and Arc EndoCuff Vision |
BODDINGTONS PLASTICS LTD |
SARAH GIBSON |
| K152297 |
02/09/2016 |
OBS Anchorage Screw |
BOMEI CO., LTD |
LINNEY CHIANG |
| K153066 |
02/09/2016 |
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens |
Boston Foundation for Sight |
Eugene Bonte |
| K163174 |
12/14/2016 |
Emerge PTCA Dilatation Catheter |
Boston Scientific Corporation |
Jane Horan |
| K152231 |
02/12/2016 |
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire |
BOSTON SCIENTIFIC CORPORATION |
Nikki M Wahlberg |
| K163200 |
12/14/2016 |
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete |
BOSTON SCIENTIFIC CORPORATION |
Ka Zoua Xiong |
| K153617 |
02/25/2016 |
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) |
BOSTON SCIENTIFIC CORPORATION |
Eric Elliott |
| K160173 |
02/26/2016 |
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) |
Boston Scientific Corporation |
Eric Elliott |
| K161215 |
12/21/2016 |
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K160941 |
12/13/2016 |
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter |
Brosmed Medical Co., Ltd. |
Tina Yin |
| K162010 |
12/13/2016 |
HPM-6000U |
BTL Industries, Inc. |
Jan Zarsky |
| K161716 |
12/21/2016 |
TEETHAN 2.0 |
BTS S.P.A. |
VERONICA BARTOLINI |
| K152736 |
02/25/2016 |
SKIN CARE |
C.I.S LTD |
ILAN SHARON |
| K162193 |
12/23/2016 |
XenMatrix AB Surgical Graft |
C.R. Bard |
Tony John |
| K162900 |
12/14/2016 |
PowerMidline Catheter |
C.R. Bard, Inc. |
Casey Coombs |
| K152136 |
02/18/2016 |
Recovery Cone Removal System |
C.R. Bard, Inc. |
Joni Creal |
| K151635 |
02/09/2016 |
CapsoCam (SV-1) |
CapsoVision, Inc. |
AZIMUN JAMAL |
| K153295 |
02/26/2016 |
TandemLung Oxygenator |
CARDIAC ASSIST, INC. |
GREG JOHNSON |
| K152568 |
02/11/2016 |
C-VBR |
CARDINAL SPINE, LLC |
NATASHA LONNON |
| K152310 |
02/24/2016 |
HeartLight Deflectable Sheath |
CARDIOFOCUS, INC. |
Seema Paliwal |
| K151036 |
02/01/2016 |
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments |
CAREFUSION 2200 INC. |
JANE WEBER |
| K152593 |
02/25/2016 |
LATEX EXAMINATION GLOVE POWDER FREE |
Careplus (M) SDN BHD |
LIM KWEE SHYAN |
| K163019 |
12/01/2016 |
CareView 750Cw/750C X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
Xu Wei |
| K163203 |
12/13/2016 |
Carestream DRX-Evolution |
Carestream Health, Inc. |
Carolyn L. Wagner |
| K153103 |
02/12/2016 |
CARESTREAM Vue PACS |
CARESTREAM HEALTH, INC. |
Diane Koetter |
| K162568 |
12/15/2016 |
INTRABEAM 600 |
CARL ZEISS MEDITEC AG |
Christian Muenster |
| K161654 |
12/30/2016 |
NuFACE Gel Primer |
Carol Cole Company |
Merle Kovacic |
| K161900 |
12/09/2016 |
HYPERION X5 |
CEFLA SC |
SILVIA SANSAVINI |
| K151337 |
02/24/2016 |
Strialite |
Centre Light Solutions, LLC |
Carrie Colburn |
| K162352 |
12/22/2016 |
derma+flex QS High Viscosity Tissue Adhesive |
CHEMENCE MEDICAL INC |
Kenneth Broadley |
| K152476 |
02/09/2016 |
Exofin High Viscosity Tissue Adhesive |
CHEMENCE MEDICAL PRODUCTS INC. |
Kenneth Broadley |
| K161329 |
12/02/2016 |
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel |
Chrono-log Corp. |
Nicholas J Veriabo |
| K153004 |
02/12/2016 |
Clear Guide SCENERGY |
CLEAR GUIDE MEDICAL |
Jack Kent |
| K161959 |
12/28/2016 |
ClearView cCAD |
ClearView Diagnostics Inc. |
Christine Podilchuk |
| K151569 |
02/12/2016 |
Tranberg CLS Laser Fiber |
Clinical Laserthermia Systems AB |
Lars Erik Eriksson |
| K151406 |
02/25/2016 |
Cogent Lateral Interbody System |
COGENT SPINE LLC |
JUDE PAGANELLI |
| K160515 |
12/19/2016 |
PS2 Knee System |
CONSENSUS ORTHOPEDICS, INC. |
JUSTIN CREEL |
| K162717 |
12/21/2016 |
Evolution Esophageal Stent System û Partially Covered |
Cook Ireland Ltd. |
Jane Kennedy |
| K163018 |
12/23/2016 |
Zilver 635 Biliary Stent |
Cook Ireland Ltd. |
Nora O'Connor |
| K161755 |
12/14/2016 |
Integrity-SI TM Fusion System |
CoorsTek Medical |
Steve Brown |
| K153211 |
02/02/2016 |
M-Fix Acromioclavicular Device |
CORACOID SOLUTIONS, INC. |
STEVE GOLDEN |
| K152237 |
02/04/2016 |
The Entasis Dual-Lead Sacroiliac Implant |
CoreLink, LLC |
Dan Hoehn |
| K162127 |
12/05/2016 |
Bencox M Stem Lateralized & Bencox Mirabo Cup System |
CORENTEC CO., LTD |
J. S. DANIEL |
| K160157 |
12/01/2016 |
LOSPA Modular Knee System |
CORENTEC CO., LTD |
Goon Hee Lee |
| K152127 |
02/04/2016 |
CorMatrix Tyke |
CORMATRIX CARDIOVASCULAR, INC. |
ANDREW M. GREEN |
| K150277 |
02/12/2016 |
Pain Therapy System, Model PTS-II |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
Eagle Eagle |
| K163055 |
12/23/2016 |
Reprocessed Kendall SCD Express Foot Cuff |
COVIDIEN |
Jennifer Sullivan |
| K163105 |
12/06/2016 |
Emprint Ablation System |
COVIDIEN LLC |
PATTI ARNDT |
| K163098 |
12/05/2016 |
Tri-Staple 2.0 Intelligent Cartridge |
Covidien LLC |
REBECCA BREWER |
| K160566 |
12/02/2016 |
Cerasorb Ortho Foam |
CURASAN AG |
Wolf-Dietrich Hubner |
| K153215 |
02/19/2016 |
SmartBase for Arthrex Glenoid IRIS |
Custom Orthopaedic Solutions, Inc. |
Keith Grafmeyer |
| K162512 |
12/09/2016 |
truSculpt |
CUTERA, INC. |
BRADLEY RENTON |
| K163067 |
12/01/2016 |
CyMedica e-viveÖ System; CY-1000 |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K161566 |
12/21/2016 |
DMS Disposable Subdermal Needle Electrodes |
Daehan Medical Systems Co., Ltd. |
Dong Cheul Kim |
| K152878 |
02/03/2016 |
SUNTEC Mechanical Wheelchair, model ST-WL-1000 |
DANYANG SUNTEC AUTO PARTS CO., LTD. |
JEN KE-MIN |
| K153191 |
02/26/2016 |
Calcium Bridge |
DENALI CORPORATION |
Jan G Stannard |
| K151945 |
02/18/2016 |
Triumph Resin Dam |
DENALI CORPORATION |
JAN G. STANNARD |
| K161244 |
12/07/2016 |
s-Clean OneQ-SL Narrow Implant System |
Dentis Co., Ltd. |
Sun Chul Shin |
| K161713 |
12/16/2016 |
Dentium CAD/CAM Abutments |
Dentium Co., Ltd |
Sangpil Yoon |
| K151439 |
02/19/2016 |
ATLANTIS ISUS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K153144 |
02/10/2016 |
TIO-H DIGITAL RADIOGRAPHY SENSOR |
DENTTIO, INC. |
YOUNG HAN |
| K152587 |
02/04/2016 |
DermaScalp Laser Cap |
DERMASCALP LLC |
JOHN CARULLO |
| K152989 |
02/25/2016 |
Mammotome revolve Dual Vacuum Assist Biopsy System |
DEVICOR MEDICAL PRODUCTS, INC. |
SHAWNA M. ROSE |
| K162227 |
12/10/2016 |
STA« - Liatest« D-Di |
Diagnostica Stago |
Arnaud Berthier |
| K152645 |
02/09/2016 |
Dictum Health |
DICTUM HEALTH, INC |
PAUL LANDESMAN |
| K153224 |
02/17/2016 |
VitalStim(R) Plus Electrotherapy System |
DJO, LLC |
Natalia Shirina |
| K151580 |
02/16/2016 |
D.N.E. External Fixation System |
DNE, LLC |
NICHOLAS RICCIONE |
| K162421 |
12/21/2016 |
IntelliCartTM System |
DORNOCH MEDICAL SYSTEMS |
LARRY SMITH |
| K162552 |
12/02/2016 |
EVS 3643, EVS 3643G |
DRTECH Corporation |
Choul-Woo Shin |
| K162555 |
12/21/2016 |
EVS 4343, EVS 4343G |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K143290 |
02/18/2016 |
DBSWIN and VistaEasy Imaging Software |
Durr Dental AG |
Oliver Lange |
| K151912 |
02/03/2016 |
AIR-FLOW handy 3.0 PLUS |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
Suzanne Fassio-Hardy |
| K152034 |
02/23/2016 |
FS-PACS |
EC-WEB CO., LTD. |
KE-MIN JEN |
| K160981 |
12/22/2016 |
Patient Monitor |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K152427 |
02/05/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K160982 |
12/22/2016 |
SphynxÖ |
Eden Spine LLC |
Guillaume Viallaneix |
| K160247 |
02/23/2016 |
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K163335 |
12/15/2016 |
6MP Color LCD Monitor, RadiForce RX660, RX660-AR |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K160949 |
12/22/2016 |
Go Dose System |
ELI LILLY AND COMPANY |
SUMITRA M GHATE |
| K162140 |
12/01/2016 |
RemLogic |
EMBLA SYSTEMS |
SHANE T. SAWALL |
| K161906 |
12/01/2016 |
SCIg60 Infuser |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K151475 |
02/08/2016 |
EndoChoice Select Injection Needle |
ENDOCHOICE, INC. |
THERON GOBER |
| K153588 |
02/24/2016 |
EndoChoice Water Bottle Cap System |
ENDOCHOICE, INC. |
Daniel Hoefer |
| K152702 |
02/18/2016 |
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) |
ENT BIOTECH SOLUTIONS |
LAURA YAMADA |
| K153340 |
02/09/2016 |
Epic Extremity Plate System |
Epic Extremity, LLC |
DAN SCHWARTZBAUER |
| K152196 |
02/18/2016 |
Erchonia EVRL |
ERCHONIA CORPORATION |
STEVEN SHANKS |
| K162578 |
12/16/2016 |
Zerona Z6 OTC |
ERCHONIA CORPORATION |
STEVEN SHANKS |
| K152691 |
02/25/2016 |
EDS Universal Cement |
ESSENTIAL DENTAL SYSTEMS, INC |
JEFFREY WAN |
| K152438 |
02/25/2016 |
ETView VivaSight-SL (TVT) system |
ETVIEW LTD. |
YORAM LEVY |
| K163539 |
12/23/2016 |
Ez3D-i / E3 |
EWOO SOFT Co., Ltd. |
Young Seok Kim |
| K162972 |
12/02/2016 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging |
Karina Torres |
| K161550 |
12/22/2016 |
DynaMesh-VENTRAL |
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT |
STEFAN SCHNEEMELCHER |
| K162176 |
12/01/2016 |
Fiagon Navigation System |
Fiagon GmbH |
Dirk Mucha |
| K160707 |
12/17/2016 |
CustomizedBone Service |
FIN-CERAMICA FAENZA SPA |
Monticelli Marina |
| DEN160020 |
12/21/2016 |
CipherOx CRI Tablet |
Flashback Technologies, Inc. |
Gordon Van Dusen |
| K152529 |
02/04/2016 |
NaturaLase CO2 Laser System |
FOCUS MEDICAL, LLC |
JOHN B LEE |
| K151474 |
02/18/2016 |
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
MARY MOORE |
| K160196 |
02/23/2016 |
Fujifilm Video Colonoscope Model EC-600WL V2 |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha More |
| K160108 |
02/03/2016 |
Synapse PACS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Jyh-Shyan Lin |
| K163053 |
12/01/2016 |
Lumipulse G E2-III Calibrators |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K152557 |
02/23/2016 |
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters |
G21 s.r.l. |
Maurizio Foroni |
| K160182 |
02/26/2016 |
LOGIQ S7 Expert |
GE Healthcare |
Bryan Behn |
| K160184 |
02/25/2016 |
Voluson S6, Voluson S8, Voluson S10 |
GE HEALTHCARE |
TRACEY ORTIZ |
| K161682 |
12/02/2016 |
GE Lunar DXA Bone Densitometers with enCORE version 17 |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC |
Nicole Landreville |
| K163213 |
12/16/2016 |
Revolution CT |
GE Medical Systems, L.L.C. |
Helen Peng |
| K160972 |
12/28/2016 |
Gexfix External Fixation |
Gexfix International Corp. |
Maurizio Longo |
| K153203 |
02/03/2016 |
Navigation Instruments |
GLOBUS MEDICAL INC. |
Kelly J Baker |
| K153368 |
02/16/2016 |
Radiance V3 |
GMV SOLUCIONES GLOBALES INTERNET S.A.U. |
CARLOS ILLANA |
| K151274 |
02/04/2016 |
Dr's Finder |
GOOD DOCTORS CO., LTD. |
Sungro Joo |
| K162442 |
12/12/2016 |
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
Martin D. Paugh |
| K152739 |
02/09/2016 |
Electronic Thermometer |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
JING LIANG |
| K153135 |
02/25/2016 |
VITAL SIGNS MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Jin Liang |
| K162747 |
12/08/2016 |
Proture Double Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Jun Deng |
| K160306 |
12/13/2016 |
Cloud Smart Thermometer |
GUANGZHOU BOSMA TECHNOLOGY CO LTD |
Guoxing Dai |
| K163373 |
12/12/2016 |
PK AIM |
Gyrus ACMI Inc. |
Graham A.L. Baillie |
| K152715 |
02/25/2016 |
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
HAINING MEDICAL PRODUCTS CO., LTD |
ZHANG LIANG |
| K162048 |
12/05/2016 |
EZstim*III Peripheral Nerve Stimulator/Nerve Locator |
HALYARD HEALTH - IRVINE |
Maria Pronina |
| K163236 |
12/16/2016 |
COOLIEF Cooled Radiofrequency Kit |
Halyard Health, Inc. |
Mary Ann B Kinard |
| K153304 |
02/01/2016 |
Hansen Medical Magellan Robotic Catheter eKit |
Hansen Medical, Inc. |
Marysa Loustalot |
| K160928 |
12/20/2016 |
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| K153489 |
02/05/2016 |
Cryocare CS Surgical System |
Health Tronics |
Maritza Ward |
| K162902 |
12/15/2016 |
ARIETTA Prologue Diagnostic Ultrasound system and Transducers |
HITACHI, LTD. |
ANGELA VAN ARSDALE |
| K160492 |
12/06/2016 |
Hospira Sapphire Sets |
Hospira, Inc |
David Blonski |
| K150157 |
02/16/2016 |
AnapnoGuard 100 Respiratory Guard System |
HOSPITECH RESPIRATION LTD. |
Yoram Levy |
| K161237 |
12/16/2016 |
HyperView Hyperspectral Tissue Oxygenation Measurement System |
HYPERMED IMAGING, INC. |
Carlyn Reynolds |
| K160742 |
12/16/2016 |
NoCoding1 Plus Blood Glucose Monitoring System |
i-SENS, INC. |
Joon Ho Jung |
| K153570 |
02/25/2016 |
Axxent Electronic Brachytherapy System Model 110 XP 1200 |
ICAD INC. |
John DeLucia |
| K151307 |
02/26/2016 |
ICONACY(TM) I-Hip (TM) |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
ROY Y HORI |
| K153204 |
02/01/2016 |
In2Bones Kirschner wire |
IN2BONES SAS |
Morgane Grenier |
| K153395 |
02/18/2016 |
OS2-C Compression Staple |
IN2BONES SAS |
MORGANE GRENIER |
| K161947 |
12/16/2016 |
Chagas Detect Plus Rapid Test |
INBIOS INTERNATIONAL, INC. |
ESTELA RAYCHAUDHURI |
| K163190 |
12/12/2016 |
InMode RF System |
INMODE MD LTD. |
Amit Goren |
| K151793 |
02/19/2016 |
InMode RF System |
INMODE MD LTD. |
AHAVA STEIN |
| K162344 |
12/20/2016 |
INNOLUX RIC |
INNOLUX CORPORATION |
Andy Kuo |
| K161827 |
12/08/2016 |
Reprocessed Response Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
SHARON HIGGINS |
| K161769 |
12/06/2016 |
Reprocessed Supreme Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
Sharon Higgins |
| K162251 |
12/21/2016 |
Reprocessed Viking Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
Sharon Higgins |
| K152505 |
02/01/2016 |
C2 NerveMonitor System |
INOMED MEDIZINTECHNIK GMBH |
SASCHKA BUSCH |
| K151429 |
02/12/2016 |
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K160415 |
12/14/2016 |
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) |
Instrumentation Laboratory Co. |
Carol Marble |
| K160412 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) |
Instrumentation Laboratory Co. |
Carol Marble |
| K160402 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) |
Instrumentation Laboratory Co. |
Carol Murble |
| K160225 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K152596 |
02/15/2016 |
Intact« Gen2 System |
INTACT MEDICAL CORPORATION |
JOHN VACHA |
| K160811 |
12/06/2016 |
CRW STEREOTACTIC SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
TIMOTHY CONNORS |
| K153275 |
02/26/2016 |
Aingeal Activity System |
Intelesens, Ltd. |
Patricia Pepper |
| K162696 |
12/28/2016 |
Kuschall Advance Manual Wheelchair |
INVACARE CORPORATION |
ELIJAH N. WREH |
| K162686 |
12/28/2016 |
Kuschall Champion Manual Wheelchair |
Invacare Corporation |
Elijah N. Wreh |
| K162692 |
12/28/2016 |
Kuschall K-Series Attract Manual Wheelchair |
INVACARE CORPORATION |
Elijah N. Wreh |
| K143369 |
12/15/2016 |
MRidium 3860+ MRI infusion Pump/ Monitoring System |
IRADIMED CORPORATION |
FRANCIS X CASEY |
| K161730 |
12/08/2016 |
Wireless Digital Flat Panel Detector |
IRAY TECHNOLOGY (SHANGHAI) LTD. |
WEI PAN |
| K160798 |
12/15/2016 |
IPS e.max« Press Abutment Solutions for Viteo Base Ti |
IVOCLAR VIVADENT AG |
Sandra Cakebread |
| K162478 |
12/22/2016 |
ivWatch |
ivWatch, LLC |
Jaclyn Lautz |
| K153605 |
02/11/2016 |
ivWatch Model 400 |
ivWatch, LLC |
Jaclyn Lautz |
| K163308 |
12/27/2016 |
SMARTO |
JEIL MEDICAL CORPORATION |
JAEHAN PARK |
| K162600 |
12/09/2016 |
Jewel Precision Reusable Rigid Sterilization Container System |
JEWEL PRECISION SHEET METAL & MACHINE, INC. |
GARY SCHNEBERGER |
| K160326 |
02/23/2016 |
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) |
JVC KENWOOD Corporation |
Tsukasa Tashiro |
| K150468 |
02/29/2016 |
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs |
K2 Medical GmbH & Co. KG |
Harald Jung |
| K153370 |
02/16/2016 |
Caspian OCT/MESA Mini/DENALI Mini Spinal System |
K2M, Incorporated |
Nancy Giezen |
| K161488 |
12/08/2016 |
ESTETICA Dental Treatment Unit and Accessories |
KALTENBACH & VOIGT GMBH |
STEFAN TRAMPLER |
| K160044 |
02/01/2016 |
Image1 SPIES System |
KARL STORZ ENDOSCOPY AMERICA, INC. |
SUSIE S. CHEN |
| K153199 |
02/29/2016 |
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack |
KCI USA, INC. |
MARGARET MARSH |
| K160487 |
12/09/2016 |
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System |
KCI USA, Inc. |
Kristen Weniger Hopewell |
| K162436 |
12/21/2016 |
EndoVac Pure |
Kerr Corporation |
Mohammad Saad Ansari |
| K161470 |
12/01/2016 |
Internal Distraction - Sterile |
KLS MARTIN LP |
JENNIFER DAMATO |
| K161259 |
12/19/2016 |
KLS Martin Cannulated Headless Screws |
KLS MARTIN LP |
JENNIFER DAMATO |
| K161127 |
12/22/2016 |
The Small PLATEAU (PLATEAU-C) Spacer System |
LIFE SPINE INC. |
RANDY LEWIS |
| K151835 |
02/05/2016 |
Vital Signs Patch System |
LIFEWATCH TECHNOLOGIES LTD. |
ASHER KASSEL |
| K162854 |
12/19/2016 |
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml |
Liofilchem s.r.l. |
Fabio Brocco |
| K162428 |
12/06/2016 |
DiLumen Endolumenal Interventional Platform |
Lumendi, LLC |
Dennis Daniels |
| K162772 |
12/23/2016 |
ARIES GBS Assay |
LUMINEX CORPORATION |
CHRISTIE HUGHES |
| K163347 |
12/15/2016 |
xTAG Cystic Fibrosis 39 Kit v2 |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K163336 |
12/15/2016 |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR |
Luminex Molecular Diagnostics, Inc. |
Jennifer Grimes |
| K153523 |
02/16/2016 |
FUSION Vascular Graft |
MAQUET CARDIOVASCULAR, LLC |
Mark Dinger |
| K160695 |
12/06/2016 |
Talymed Suspension |
Marine Polymer Technologies, Inc. |
Sergio Finkielsztein |
| K162675 |
12/28/2016 |
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K151644 |
02/12/2016 |
Masimo Root Vital Signs Monitoring System and Accessories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K160063 |
02/25/2016 |
McLaren Proton Therapy System |
McLaren Health Care Corporation |
Ryan Vlcko |
| K142969 |
02/23/2016 |
ANI Monitor |
MDOLORIS MEDICAL SYSTEMS SAS |
MATHILDE COLLET |
| K160198 |
02/23/2016 |
UreTron MultiProbe Lithotripter System |
Med-Sonics Corp |
Jennifer Rautine |
| K163311 |
12/21/2016 |
GMK Revision Femoral Distal Augmentation |
Medacta International SA |
Stefano Baj |
| K153246 |
02/12/2016 |
PTFE Super Sheath Introducer 2.1 |
MEDCOMP (MEDICAL COMPONENTS, INC.) |
COURTNEY NIX |
| K161128 |
12/01/2016 |
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply |
Medela AG |
Markus Butler |
| K152410 |
02/02/2016 |
Top Fine Pen Needle |
MEDEXEL CO., LTD. |
CHA DONG IK |
| K153091 |
02/25/2016 |
IMPLANT 3D |
Media Lab S.r.l. |
Massimo Ivani |
| K152327 |
12/01/2016 |
EasyLyte Na/K/Cl/Ca Analyzer |
Medica Corporation |
Photios Makris |
| K161916 |
12/21/2016 |
TelePatch Cardiac Monitor |
MEDICOMP, INC. |
Sean Marcus |
| K162194 |
12/08/2016 |
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System |
MEDICREA INTERNATIONAL S.A |
DAVID RYAN |
| K150487 |
02/12/2016 |
X-Suit NIR Biliary Metallic Stent |
MEDINOL LTD. |
Michal Hershkovitz |
| K162128 |
12/21/2016 |
Scope Buddy Plus Endoscope Flushing Aid |
MEDIVATORS INC. |
Kristin Bergeson Padilla |
| K152948 |
02/04/2016 |
Medline Anti-Fog Solution |
Medline Industries, Inc. |
Matt Clausen |
| K162829 |
12/09/2016 |
Medline UNITE« Ankle Fracture Plating System |
MEDLINE, INDUSTRIES, INC. |
Jennifer Mason |
| K163106 |
12/01/2016 |
CODMAN Integrated Bipolar Cord and Tubing Set |
Medos International SARL |
Megan Palumbo |
| K162247 |
12/15/2016 |
PERMATAPE |
MEDOS INTERNATIONAL SARL |
TATYANA KORSUNSKY |
| K160879 |
12/20/2016 |
CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems |
Medos International Sαrl |
KIRSTEN LEMULLER |
| K162327 |
12/12/2016 |
COUGAR« LS Lateral Cage System and COUGAR« System |
Medos International, Sarl |
Eric Zhu |
| K162912 |
12/08/2016 |
VIPER PRIMEÖ additions to the VIPER« System |
MEDOS INTERNATIONAL, SARL |
Karen Sylvia |
| K161400 |
12/08/2016 |
ImagingRing System |
MEDPHOTON GMBH |
Daniel Schaffarzick |
| K163158 |
12/02/2016 |
MEDSYNAPSE Zero Footprint Viewer |
MEDSYNAPTIC PRIVATE LTD. |
Ashish Dhawad |
| K162604 |
12/30/2016 |
Cranial Reducing Tubes |
MEDTRONIC NAVIGATION, INC. |
Christopher Perman |
| K153247 |
02/18/2016 |
Fusion Compact Navigation System |
MEDTRONIC NAVIGATION, INC. |
RISHI SINHA |
| K153589 |
02/10/2016 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
ANKIT K. SHAH |
| K153442 |
02/18/2016 |
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATIO |
Medtronic Sofamor Danek USA, Inc. |
Lila Joe |
| K163301 |
12/20/2016 |
CD HORIZON« Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Justin O'Connor |
| K162680 |
12/14/2016 |
SOVEREIGN« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KANESHA HINES |
| K162896 |
12/06/2016 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface |
MEDTRONIC, INC. |
RENEE CVEYKUS |
| K152496 |
02/19/2016 |
CPX 4 Breast Tissue Expander |
MENTOR WORLDWIDE LLC |
Manchi Cheung |
| K152187 |
02/12/2016 |
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K160771 |
12/19/2016 |
Destiknee Total Knee System |
MERIL HEALTHCARE PRIVATE LIMITED |
Umesh Sharma |
| K153081 |
02/15/2016 |
Clear Bi-Light |
Michael Todd, LP |
Lilia Friend |
| K161728 |
12/05/2016 |
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 |
MICROFILE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K153077 |
02/12/2016 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K152743 |
02/08/2016 |
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) |
MICROLINE SURGICAL, INC. |
ANU GAUR |
| K161639 |
12/22/2016 |
Y-MIC |
MICRON CORPORATION |
Takashi Terui |
| K163154 |
12/09/2016 |
Traxcess 7 Mini XSoft Guidewire |
MicroVention, Inc. |
Sapna Singh |
| K162630 |
12/20/2016 |
CP Relief Wand-OTC |
Mid-America Medical Innovations LLC |
Norm Schroeder |
| K153059 |
02/02/2016 |
HF1202H PowerPlus Portable X-ray Equipment |
MINXRAY, INC. |
Keith Kretchmer |
| K161871 |
12/19/2016 |
EVA (Enhanced Visual Assessment) System |
MobileODT Ltd. |
Jen Acobas |
| K153426 |
12/21/2016 |
Ox-Imager CS |
MODULATED IMAGING, INC. |
DAVID CUCCIA |
| K152626 |
02/26/2016 |
H3+ Holter Recorder |
MORTARA INSTRUMENT, INC |
Margaret Mucha |
| K161425 |
12/05/2016 |
APEX Manual Wheelchair |
Motion Composites |
Stephane Le Beau |
| K152422 |
02/17/2016 |
FRENDÖ Free T4 Test System |
NANOENTEK USA INC |
JIMMY CHEN |
| K151476 |
02/26/2016 |
Beactive Brace |
NATURES PILLOWS, INC. |
WILLIAM McALISTER |
| K160745 |
12/12/2016 |
neoBLUE compact LED Phototherapy System |
NATUS MEDICAL INCORPORATED |
THERESE LEGGIERE |
| K163163 |
12/14/2016 |
XLTEK EMU40EX EEG Headbox |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K161399 |
12/22/2016 |
Neocis Guidance System |
Neocis Inc. |
Alon Mozes |
| K161467 |
12/22/2016 |
HydraGuard 10 UltraFilter |
NEPHROS INC. |
JAMES SUMMERTON |
| K152664 |
12/02/2016 |
TAV System |
New Aera, Inc. |
ERIC JOHANSSON |
| K161307 |
12/21/2016 |
NICO Myriad |
NICO CORPORATION |
SEAN SPENCE |
| K153479 |
02/16/2016 |
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System |
NINEPOINT MEDICAL, INC |
EMAN NAMATI |
| K162869 |
12/09/2016 |
Contact Lens Case |
Ningbo Yinzhou Zonghai Artware Co., Ltd. |
Weng Changhai |
| K160231 |
12/23/2016 |
Model X-100C CO-MetÖ Oximetry System |
NONIN MEDICAL, INC. |
KIM E. AVES |
| K152088 |
02/24/2016 |
IV-eye |
Novarix Limited |
JOHN SCOTT |
| K160392 |
02/26/2016 |
Novilase Laser Therapy System, Model LTS-2 |
NOVIAN HEALTH, INC. |
WILLIAM GRAVEMAN |
| K153054 |
02/05/2016 |
N5-1 |
NUGA MEDICAL CO., LTD |
JONG SOO LEE |
| K150826 |
02/10/2016 |
Nutra Face Lift Model PE8050 |
NUTRA LUXE MD, LLC |
PETER VON BERG |
| K162371 |
12/15/2016 |
Pulsaderm ACE-All Blue |
Nutra Luxe MD, LLC |
Gloria Avendano |
| K153625 |
02/12/2016 |
Single Use Injector NM600/610 |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K151743 |
02/26/2016 |
THUNDERBEAT Open Fine Jaw |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K152332 |
02/25/2016 |
Perfectio LED infrared device |
OMM IMPORTS INC DBA ZERO GRAVITY |
OHAD MENACHEM |
| K152991 |
02/11/2016 |
OptoWire Deux |
OPSENS |
Vanessa Mootoosamy |
| K153080 |
02/11/2016 |
RTVue XR OCT Avanti with AngioVue Software |
OPTOVUE, INC. |
EDWARD SINCLAIR |
| K163180 |
12/29/2016 |
Hubble II |
Orbbo Surgical, LLC |
Eric Garofano |
| K152813 |
12/02/2016 |
FS-500DDR Medical Radiographic X-Ray System |
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. |
JU PENG |
| K152932 |
02/29/2016 |
BlastGen |
ORIGIO A/S |
TOVE KJAER |
| K151737 |
02/25/2016 |
MedicVOD System |
Orpheus Medical Ltd. |
Asaf Omer |
| K162020 |
12/16/2016 |
VITROS Chemistry Products Cl- Slides |
Ortho Clinical Diagnostics |
Marlene Hanna |
| K153216 |
02/18/2016 |
Alpine Cemented Hip System |
ORTHO DEVELOPMENT CORPORATION |
Drew Weaver |
| K162638 |
12/16/2016 |
CETRA Anterior Cervical Plate System |
Orthofix Inc. |
Jacki Koch |
| K162446 |
12/22/2016 |
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System |
ORTHOFIX INC. |
JACKI KOCH |
| K153608 |
02/12/2016 |
Vitoss BiModal Bone Graft Substitute Foam Strip |
ORTHOVITA, INC. |
LYNN LUNDY |
| K153141 |
02/04/2016 |
DyeVert Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K153015 |
12/05/2016 |
Transfer & Angled Abutment |
Osstem Implant Co., Ltd |
Hee Kwon |
| K161197 |
12/21/2016 |
Orthodontic Screw |
OSSTEM IMPLANT CO., LTD. |
NA HEEKWON |
| K151553 |
02/10/2016 |
Anterior Cervical Plate System |
Osteomed Implantes, LTDA |
J.D. WEBB |
| K152485 |
02/16/2016 |
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm |
OSTIAL CORPORATION |
JAKE WOLENBERG |
| K143596 |
02/05/2016 |
MINIARS SCREWS |
OVERMED SRL. |
DAVIDE PIZZAMIGLIO |
| K150304 |
02/24/2016 |
Oxyless Blood Tubing Set |
Oxyless Ltd |
Bob Duffy |
| K153528 |
02/01/2016 |
PacEndo EDTA |
PAC-DENT INTERNATIONAL, INC. |
Wenying Zhu |
| K152489 |
02/04/2016 |
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray |
PANORAMIC CORP. |
Doug Pack |
| K152416 |
02/26/2016 |
Indego |
PARKER HANNIFIN CORPORATION |
ACHILLEAS DOROTHEOU |
| K162233 |
12/23/2016 |
Kurin Blood Culture Collection Set |
Pathway LLC |
Emily Davis |
| K161739 |
12/19/2016 |
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
PEGAVISION CORPORATION |
Judith Hou |
| K150960 |
12/01/2016 |
WoundPro Negative Pressure Wound Therapy System |
PENSAR MEDICAL LLC |
BRIAN GUTHRIE |
| K150597 |
02/29/2016 |
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite |
PHADIA AB |
Carina Magnusson |
| K161800 |
12/06/2016 |
OnSite-IV |
PHARMC, LLC |
CHRIS TICE |
| K151435 |
02/25/2016 |
MRCAT |
PHILIPS MEDICAL SYSTEMS MR FINLAND |
JANNE MARVOLA |
| K162955 |
12/19/2016 |
Multi-Modality Tumor Tracking (MMTT) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K162940 |
12/30/2016 |
MultiBand SENSE |
Philips Medical Systems Nederland B.V. |
Jan Van de Kerkhof |
| K162859 |
12/02/2016 |
Allura Xper FD series and Allura Xper OR Table series |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| K160315 |
02/19/2016 |
I4 (Integrated Intelligent Imaging Informatics) system |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
Ilana Ben Moshe |
| K162418 |
12/02/2016 |
Pioneer Plus Catheter |
PHILIPS VOLCANO |
MARY STANNERS |
| K153593 |
02/17/2016 |
CliniscanSM MRI |
PICOFEMTO LLC |
Jessica Phillips |
| K162376 |
12/08/2016 |
CAAS MR 4D Flow |
PIE MEDICAL IMAGING B.V. |
ANNEMIEK BOUTS |
| K151545 |
12/22/2016 |
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K162282 |
12/22/2016 |
CardioChek Plus Test System, CardioChek Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Margo Enright |
| K161809 |
12/06/2016 |
ShurFit CpTi-HA ACIF Interbody Fusion System |
Precision Spine, Inc. |
Michael C. Dawson |
| DEN150038 |
12/16/2016 |
CleanCisionTM Wound Retraction and Protection System |
Prescient Surgical |
Lisa Ruehlow |
| K152278 |
02/09/2016 |
ENDOFLOW II - Irrigation, Warming and Suction System |
PROMEPLA SAM |
ALEXANDRE BAREILLE |
| K162246 |
12/08/2016 |
ProNova SC360 Proton Therapy System |
ProNova Solutions, LLC |
ADAM KUHN |
| K163068 |
12/22/2016 |
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent |
Q UROLOGICAL CORPORATION |
SCOTT EPSTEIN |
| K162623 |
12/09/2016 |
16ch T/R Hand Wrist Coil |
QUALITY ELECTRODYNAMICS, LLC |
KATHLEEN ARAS |
| K163222 |
12/05/2016 |
Discovery Pico Family |
Quanta System Spa |
Francesco Dell'Antonio |
| K163009 |
12/01/2016 |
Litho |
Quanta System SpA |
FRANCESCO DELL' ANTONIO |
| K162304 |
12/06/2016 |
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets |
QUEST MEDICAL, INC. |
Amy Clendening-Wheeler |
| K162468 |
12/01/2016 |
ClearCheck |
RADFORMATION |
KURT SYSOCK |
| K161613 |
12/28/2016 |
Hang&Go PAC |
RanD S.r.l. |
Simone Ceretti |
| K152343 |
02/16/2016 |
Direct Bilirubin |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K152085 |
02/24/2016 |
Liquid CO2-2 (LCO2-2) |
RANDOX LABORATORIES LTD |
PAULINE ARMSTRONG |
| K162066 |
12/02/2016 |
Reliance Spinal Screw System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K162051 |
12/14/2016 |
Cryotec |
REPROLIFE INC. |
KOICHI TAKEDA |
| K160836 |
12/15/2016 |
Menai System |
ResMed Ltd |
Greg Dockar |
| K153095 |
02/17/2016 |
ROP Resorbable Hemostasis Material |
Resorbable Orthopedic Products, LLC |
Barry E Constantine |
| K160614 |
12/16/2016 |
Xcite Clinical Station |
RESTORATIVE THERAPIES INC. |
Andrew Barriskill |
| K162677 |
12/21/2016 |
L- OVC |
Rhondium, Ltd |
Greer Fricker |
| K161734 |
12/09/2016 |
Vanguard Dental Unit |
RITTER CONCEPT GMBH |
WEN FANG |
| K160475 |
12/14/2016 |
Ritter Dental Implant System |
Ritter Implants GmbH & Co. KG |
Werner Schmitz |
| K153307 |
02/12/2016 |
HS SutureTape |
RIVERPOINT MEDICAL |
Edwin Anderson |
| DEN150057 |
12/19/2016 |
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 |
ROCHE DIAGNOSTICS |
Edie Eads |
| K160915 |
12/14/2016 |
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker |
ROCHE DIAGNOSTICS |
Adam Clark |
| K160571 |
12/19/2016 |
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay |
Roche Diagnostics Operations (RDO) |
David Tribbett |
| K152827 |
02/19/2016 |
Weely Manual Wheelchair |
Rupiani |
Jean-Marie Mangenot |
| K162531 |
12/29/2016 |
STERISPINE CC |
SAFE ORTHOPAEDICS |
SOPHIE REHAULT |
| K163206 |
12/15/2016 |
SMD-Sr90-DA Radionuclide Brachytherapy Source |
Salutaris Medical Devices, Inc. |
Laurence Marsteller |
| K163115 |
12/07/2016 |
GC70 |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K153529 |
02/02/2016 |
WS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
Kyeong-Mi Park |
| K151308 |
02/09/2016 |
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set |
SCHOELLY FIBEROPTIC, GMBH |
SANDRA BAUMANN |
| K162351 |
12/01/2016 |
SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device |
SEASPINE ORTHOPEDICS CORPORATION |
Gina Flores |
| K161928 |
12/21/2016 |
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL |
Sebia |
Karen Anderson |
| K163078 |
12/08/2016 |
DC-UIBC-CAL |
SEKISUI DIAGNOSTICS P.E.I. INC. |
PENNY WHITE |
| K152781 |
02/12/2016 |
Adena-Zina System |
SHANGHAI SANYOU MEDICAL CO, LTD |
DAVID FAN |
| K160092 |
02/12/2016 |
Digital Electrocardiograph |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Hongbo Zhong |
| K152902 |
02/18/2016 |
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANHONG BAI |
| K162845 |
12/15/2016 |
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
ZHAI PEI |
| K151258 |
02/18/2016 |
Arm automatic blood pressure monitor |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
Xie Qiongyu |
| K160969 |
12/12/2016 |
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler |
SHINEMED LLC |
ROGELIO A. INSIGNARES |
| K163306 |
12/22/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
Plessy Paul |
| K162420 |
12/12/2016 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
PETRA DISSMANN |
| K162688 |
12/26/2016 |
Sysmex CS-2100i |
Siemens Healthcare Diagnostics Products GmbH |
Donna Noeh |
| K151529 |
02/11/2016 |
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
JULIE WARREN |
| K153232 |
02/10/2016 |
Cios Select |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K162302 |
12/16/2016 |
Somatom Confidence « RT Pro |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K153220 |
02/19/2016 |
syngo.CT Single Source Dual Energy (Twin Beam) |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K160317 |
02/29/2016 |
syngo.via MI Workflows |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Veronica Padharia |
| K153759 |
02/25/2016 |
SIGN Compression Screw System |
SIGN FRACTURE CARE INTERNATIONAL |
ROB R. TEETER |
| K152831 |
02/23/2016 |
Spot Skan |
SKANRAY TECHNOLOGIES PRIVATE LIMITED |
MAHADEVAN J |
| K151512 |
02/14/2016 |
Star 60 |
SKANRAY TECHNOLOGIES PRIVATE LIMITED |
MAHADEVAN J |
| K161233 |
12/14/2016 |
OXINIUM DH Fermoral Heads |
SMITH & NEPHEW, INC. |
MIKE SCOTT |
| K163086 |
12/21/2016 |
VLP MINI-MOD 2.0mm Column Plates |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K163034 |
12/07/2016 |
SUTUREFIX Curved Suture Anchor |
Smith and Nephew, Inc. |
Anne-Marie Keefe |
| K160946 |
12/05/2016 |
4.0 and 6.5 Cancellous Bone Screw and Washer |
SMV SCIENTIFIC |
Nephi Zufelt |
| K160942 |
12/21/2016 |
Sonablate |
SonaCare Medical, LLC |
DAVID M. HERNON |
| K163063 |
12/12/2016 |
UC-5000 Mobile X-Ray |
SOURCE-RAY, INC. |
RAY MANEZ |
| K161548 |
12/01/2016 |
Osseointegrated Fixtures |
SOUTHERN IMPLANTS (PTY) LTD. |
LAURANDA BREYTENBACH |
| K151069 |
02/05/2016 |
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle |
SPECTRA MEDICAL DEVICES, INC. |
Agustin Turriza |
| K153530 |
02/05/2016 |
Bridge Occlusion Balloon |
SPECTRANETICS, INC. |
Christopher McLellan |
| K152539 |
02/24/2016 |
SpineView X-Pac Expandable Lumbar Cage System |
SPINE VIEW, INC. |
Mbithi Muthini |
| K160003 |
02/26/2016 |
Sniper (R) Spine System |
SPINE WAVE, INC. |
KELLY Barbieri |
| K153323 |
02/23/2016 |
Palisade Pedicular Fixation System |
SPINEOLOGY, INC. |
JACQUELINE A HAUGE |
| K153082 |
02/04/2016 |
Rampart A Lumbar Interbody Fusion Device |
SPINEOLOGY, INC. |
JACQUELINE A HAUGE |
| K152922 |
02/19/2016 |
ViziShot FLEX |
SPIRATION, INC. |
Cyndy J Adams |
| K160335 |
12/13/2016 |
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D |
St. Jude Medical |
Tamara Stanczak |
| K160218 |
12/13/2016 |
AutoMark Module |
St. Jude Medical |
Melissa Frank |
| K160210 |
12/13/2016 |
EnSite Precision Cardiac Mapping System v2.0 |
ST. JUDE MEDICAL |
Marlene Peterson |
| K162643 |
12/13/2016 |
MediGuide Technology System |
ST. JUDE MEDICAL |
MARLENE PETERSON |
| K152009 |
12/05/2016 |
DENSEEMAMMO v1.0 |
STATLIFE |
STEPHANE RAGUSA |
| K153173 |
02/05/2016 |
MOR Implant System |
STERNGOLD DENTAL, LLC |
MARIA RAO |
| DEN160005 |
12/19/2016 |
Hem-Avert Perianal Stabilizer |
STETRIX, INC. |
MARK BUCHANAN |
| K162161 |
12/16/2016 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K162702 |
12/30/2016 |
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table |
STL International, Inc. |
Rylie Teeter Leier |
| K160585 |
12/22/2016 |
XN CAL |
Streck |
Deborah Kipp |
| K160590 |
12/22/2016 |
XN CHECK |
STRECK |
DEBORAH KIPP |
| K160588 |
12/22/2016 |
XN CHECK BF |
STRECK |
DEBORAH KIPP |
| K160586 |
12/22/2016 |
XN-L CHECK |
STRECK |
DEBORAH KIPP |
| K153508 |
02/05/2016 |
Stryker CMF MEDPOR Customized Implant |
Stryker |
Jonathan Schell |
| K161821 |
12/08/2016 |
Stryker Universal Mesh |
Stryker |
Jonathan Schell |
| K152266 |
12/02/2016 |
Altrix Precision Temperature Management System |
STRYKER MEDICAL |
BRIAN ORWAT |
| K160096 |
02/19/2016 |
InZone Detachment System |
STRYKER NEUROVASCULAR |
KATE TAYLOR |
| K151520 |
02/19/2016 |
Oscar 2 |
SunTech Medical, Inc. |
Charles Setzer |
| K151680 |
02/12/2016 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
SUQIAN XINGYE GLOVE CO, LTD |
JIAN ZHONG-DENG |
| K152271 |
02/09/2016 |
Powder Free Nitrile Patient Examination Gloves, Black color |
SUQIAN XINGYE GLOVE CO,LTD |
JIAN ZHANG DENG |
| K163028 |
12/28/2016 |
Medline ReNewal Reprocessed Stryker External Fixation Devices |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K152648 |
02/18/2016 |
Ennova Self-adhesive Electrode |
Suzhou Ennova Electronics Technology Co.,Ltd |
N/A N/A |
| K162004 |
12/05/2016 |
PREMIUM Implant Systems SHELTA Implant Systems |
SWEDEN & MARTINA S.p.A. |
Alessia Pezzato |
| K160538 |
12/22/2016 |
Sysmex XN-L Automated Hematology Analyzer |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
| K151263 |
02/19/2016 |
Venturi Gauze Wound Care Sets with Portal Drain |
TALLEY GROUP LTD. |
ROBERT MACDONALD |
| K162022 |
12/22/2016 |
Collagentex Rx-1 |
Tanses Technologies inc. |
Kirk Kiremitci |
| K153690 |
02/22/2016 |
PriMatrix Dermal Repair Scaffold |
TEI BioSciences Inc. |
David D Cox |
| K160309 |
12/22/2016 |
Neurosoft TMS |
TeleEMG, LLC |
Joe F Jabre |
| K160070 |
12/07/2016 |
Rheumatoid Factor (RF) Kit for use on SPAPLUS |
THE BINDING SITE GROUP, LTD. |
Jon Lauder |
| K162003 |
12/21/2016 |
IMSE Cervical Cage |
The Institute of Musculoskeletal Science & Education |
Ed McShane |
| K152168 |
02/05/2016 |
Love Liquid Personal Lubricant |
The Kama Sutra Company |
Marla Lee |
| K160328 |
02/25/2016 |
DIVA ZSP2105CMI with QUBYX PerfectLum bundle |
THE LINDEN GROUP CORP. |
ROBERT COLAIZZO |
| K160222 |
12/07/2016 |
OIC Cervical PEEK Spacer |
THE ORTHOPAEDIC IMPLANT COMPANY |
DOUGLAS FULTON |
| K153647 |
02/16/2016 |
TSolution One w/ACG+ Surgical System |
THINK SURGICAL INC. |
IN K. MUN |
| K162648 |
12/12/2016 |
U-Blade Veress Needle |
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
TAO FAN |
| K151508 |
02/25/2016 |
IRENE Locking Compression Plate System |
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
YIFAN FU |
| K161972 |
12/09/2016 |
Slit Lamp SL-D301 |
TOPCON CORPORATION |
MICHAEL GUSEL |
| K161789 |
12/27/2016 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER SAS |
AYMEN AZAIEZ |
| K160113 |
02/17/2016 |
ST AIA-PACK hsE2 Calibrator Set |
TOSOH BIOSCIENCE, INC. |
ROBERT L WICK |
| K152778 |
12/21/2016 |
TRACOE Cuff Pressure Monitor |
TRACOE MEDICAL GMBH |
STEPHAN KOHLER |
| K153575 |
02/26/2016 |
Tyber Medical Trauma Screw |
TYBER MEDICAL LLC |
Mark F Schenk |
| K161032 |
12/22/2016 |
neon3Ö universal OCT spinal stabilization |
ULRICH GMBH & CO. KG |
Christoph Ulrich |
| K161723 |
12/21/2016 |
ulrich Transfer Set |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K153677 |
02/25/2016 |
The Cellfina System |
ULTHERA, INC. |
Suzon Lommel |
| K153384 |
02/19/2016 |
Low Potassium Dextran Solution with Tris Diluent |
United Therapeutics Corporation |
Rita Lee |
| K162476 |
12/12/2016 |
Varian High Energy Linear Accelerator |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K161702 |
12/06/2016 |
Endura guidewire |
Vascular Solutions, Inc. |
BEKA VITE |
| K160377 |
12/02/2016 |
V-varnish Premium |
Vericom Co., Ltd. |
Myung-Hwan Oh |
| K152082 |
02/26/2016 |
Vesocclude Polymer Ligating Clip |
Vesocclude Medical, LLC |
Freddy Cannady |
| K161757 |
12/05/2016 |
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads |
VICTOR MEDICAL INSTRUMENTS CO.,LTD. |
Yunhuo Chen |
| K152894 |
02/26/2016 |
VIVIX-S 1717N |
Vieworks Co., Ltd |
Yoonjae Im |
| K152855 |
02/26/2016 |
VIVIX-S 1012N |
VIEWORKS CO., LTD. |
YOONJAE IM |
| K152611 |
02/19/2016 |
V20 system |
VIORA LTD. |
OMRI KESLER |
| K153548 |
02/22/2016 |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
VISIONSENSE LTD |
ALEX CHANIN |
| K160001 |
02/12/2016 |
TraumaCad Mobile Release 2.0 |
Voyant Health Ltd |
Yael Guttentag |
| K151237 |
02/09/2016 |
Nutrisafe 2- ENFit Adaptor |
VYGON |
Jillian Mikovich |
| K161453 |
12/05/2016 |
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
| K162343 |
12/14/2016 |
Westmed Gas Sampling Cannula with O2 delivery |
WESTMED, INC. |
DIANA UPP |
| K153543 |
02/12/2016 |
WHILL Model M |
WHILL, INC. |
TERESE BOGUCKI |
| K160849 |
12/15/2016 |
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
CHIH-WEN TSAI |
| K161322 |
12/07/2016 |
CT CoPilot |
ZEPMED, LLC. |
Douglas J. Bates |
| K160852 |
12/15/2016 |
Zia |
Zetta Medical Technologies, LLC. |
Main M. Ghazal |
| K162259 |
12/21/2016 |
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
ZIBO DAIYANG PLASTIC COMPANY |
YANG YAN HONG |
| K161390 |
12/19/2016 |
Vinyl Exam Gloves, Powder Free, Clear |
Zibo Hongchin Plastic and Rubber Co., Ltd |
James Ren |
| K153028 |
02/05/2016 |
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue |
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD. |
Fufang Wang |
| K153631 |
02/16/2016 |
Zimmer Virage OCT Spinal Fixation System |
Zimmer Spine, Inc |
Ted Kuhn |
| K162114 |
12/12/2016 |
Photon, Photon Plus |
Zolar Technology & MFG Co. Inc. |
Paul Atkins |
