| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K170330 |
02/06/2017 |
3M Protemp Cement Temporary Dental Cement |
3M Company |
Gretchen Keenan |
| K162916 |
02/24/2017 |
3NT endoscopy system |
3NT Medical Ltd. |
Ehud Bendory |
| K163709 |
02/28/2017 |
FIRMap Catheter |
ABBOTT ELECTROPHYSIOLOGY |
DENNIS POZZO |
| K170160 |
02/15/2017 |
Abbott ARCHITECT Free T3 |
Abbott Laboratories |
Linda Sohn |
| DEN160032 |
02/23/2017 |
Accelerate Pheno system, Accelerate Phenotest BC Kit |
ACCELERATE DIAGNOTICS |
MAUREEN MENDE |
| K172388 |
12/22/2017 |
VPOD ITPR |
Advanced Circulatory System, a wholly owned subsidiary of |
Anja Metzger |
| K172931 |
12/01/2017 |
DUS-6000 Digital Ultrasonic Diagnostic Imaging System |
Advanced Instrumentations, Inc. |
Jorge Millan |
| K172966 |
12/08/2017 |
CMS-2000 Central Monitoring System |
Advanced Instumentations, Inc. |
Jorge Millan |
| K162007 |
02/16/2017 |
STERRAD NX Sterilizer |
Advanced Sterilization Products |
Nazanin Yacobi |
| DEN170075 |
12/19/2017 |
ContainOR |
Advanced Surgical Concepts Ltd. |
Edward Hyland |
| K172529 |
12/05/2017 |
Vivaer ARC Stylus |
Aerin Medical, Inc. |
Shannon Scott |
| K161853 |
02/27/2017 |
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System |
AESCULAP INC. |
KATHY A. RACOSKY |
| K173550 |
12/14/2017 |
Akros FibuLinkÖ Syndesmosis Repair Kit |
Akros Medical |
Charles Horrell |
| K173538 |
12/04/2017 |
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K163551 |
02/03/2017 |
LenSx Laser System |
Alcon Laboratories, Inc. |
James Arganda |
| K173502 |
12/13/2017 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
Alere Scarborough, Inc. |
Benjamin Crystal |
| K171581 |
12/22/2017 |
Neuro Omega System |
Alpha Omega Engineering Ltd, |
Maysana Mousa |
| K172732 |
12/14/2017 |
E-CUBE 8 |
ALPINION MEDICAL SYSTEMS Co., Ltd. |
Boyeon CHO |
| K163061 |
02/06/2017 |
Altus Spine Cervical Plate System |
Altus Partners, LLC |
Claudia Hill |
| K170553 |
12/01/2017 |
Altus Spine Interbody Fusion System |
Altus Partners, LLC |
Mark Melton |
| K161996 |
02/16/2017 |
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE |
Amend Surgical, Inc. |
Robert Lane |
| K172908 |
12/07/2017 |
Q-Switched Nd:YAG Laser System |
AMI Inc. |
Hae Youn Lee |
| K171037 |
12/27/2017 |
PoreStar Patient Specific Implant |
Anatomics Pty Ltd |
Joanne Flatley |
| K153561 |
02/16/2017 |
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System |
ANDON HEALTH CO., LTD |
Yi Liu |
| K162915 |
02/08/2017 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K162668 |
02/14/2017 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
LIU YI |
| K162144 |
02/01/2017 |
iHealth Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
Liu Yi |
| K170258 |
02/21/2017 |
SpeedLyser Infusion Catheter Kit |
AngioDynamics, Inc. |
Teri Juckett |
| K172494 |
12/15/2017 |
PROTEUS PTA Balloon Catheter with Embolic Capture Feature |
Angioslide, Ltd. |
Eran Vickus |
| K173017 |
12/15/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| K173008 |
12/26/2017 |
SCS 17-01 |
Anika Therapeutics, Inc. |
Steven Chartier |
| K171737 |
12/29/2017 |
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves |
Ansell Healthcare Products LLC |
Robert Mahler |
| K161413 |
02/09/2017 |
Low Profile Balloon Feeding Device |
APPLIED MEDICAL TECHNOLOGY, INC. |
Michelle Scott |
| K160857 |
02/24/2017 |
HF 718BD X-Ray System |
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION |
GUIDO ARQUILLA |
| K162608 |
02/14/2017 |
ClariFix Device |
ARRINEX, INC. |
VAHID SAADAT |
| K163513 |
02/24/2017 |
Arrow Endurance Extended Dwell Peripheral Catheter System |
Arrow International, Inc. (subsidiary of Teleflex Inc.) |
Fallon Young |
| K162032 |
02/21/2017 |
Arrowhead Mini-Rail Fixator |
Arrowhead DE, LLC |
Thomas J. Twardzik |
| K172052 |
12/13/2017 |
Arthrex DynaNite Nitinol Staple |
Arthrex Inc. |
Rebecca R. Homan |
| K170414 |
12/14/2017 |
Arthrex Univers Revers Apex Humeral Stems |
Arthrex Inc. |
David L. Rogers |
| K162391 |
02/21/2017 |
AlignMATEÖ Lapidus Arthrodesis System |
ARTHROSURFACE, INC. |
PHANI PUPPALA |
| K172383 |
12/22/2017 |
Arthrosurface Bone Screws |
Arthrosurface, Inc. |
Dawn J. wilson |
| K172228 |
12/15/2017 |
pioli IOL Delivery System |
AST Products, Inc. |
William Lee |
| K162918 |
02/09/2017 |
Atlas Spine Expandable Interbody System |
Atlas Spine, Inc. |
Thomas Smith |
| K161587 |
02/01/2017 |
Memodyn Staple |
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT |
AL AUSTIN |
| K171584 |
12/22/2017 |
B. Braun Tear-Away Introducer Needle |
B. Braun Medical Inc. |
Kimberly Smith |
| DEN150035 |
02/03/2017 |
SEEKER System |
Baebies, Inc. |
Vamsee Pamula |
| K172922 |
12/21/2017 |
MMPC-4127F1 |
Barco N.V. |
Lieven De Wandel |
| K163245 |
02/28/2017 |
Virtual Occupational Therapy Application (VOTA) |
Barron Associates, Inc. |
Bruce G. Wilson |
| K173480 |
12/11/2017 |
Crystalsert Lens Delivery System |
Bausch & Lomb, Inc |
Gary Rauvola |
| K172912 |
12/07/2017 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) |
Beckman Coulter Inc. |
Shannon Popson |
| K172255 |
12/01/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) |
Beckman Coulter, Inc |
Shannon Popson |
| K172337 |
12/15/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) |
Beckman Coulter, Inc. |
Teresa S. Wong |
| K161810 |
02/09/2017 |
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial |
BECTON DICKINSON |
Ashanti C. Brown |
| K161552 |
02/02/2017 |
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe |
Becton Dickinson and Company |
John Blewitt |
| K163591 |
02/27/2017 |
BD PosiFlush Heparin Lock Flush Syringe |
Becton Dickinson and Company |
Aakash Jain |
| K173354 |
12/15/2017 |
BD Nexiva Diffusics Closed IV Catheter Systems |
Becton Dickinson Infusion Therapy Systems, Inc. |
Henry Boland |
| K170283 |
02/28/2017 |
BD Nexiva Diffusics Closed IV Catheter System |
Becton, Dickinson and Company |
Amy Honey |
| K161926 |
02/22/2017 |
ND YAG Q-switch Laser Therapy Machine |
Beijing ADSS Development Co., Ltd |
Gao Yurong |
| K162089 |
02/10/2017 |
Blood Pressure Monitor |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
LEI CHEN |
| K163123 |
02/02/2017 |
Q-Switched Nd:YAG Laser Therapy Systems |
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
HUAN KONG |
| K151834 |
02/22/2017 |
BEMER Classic Set, BEMER Pro-Set |
BEMER Int. AG |
Sven Bieler |
| K171061 |
12/28/2017 |
MRSASelect II |
Bio-Rad |
Sylvie Fernez |
| K152432 |
02/03/2017 |
ActiPatch(R) |
BIOELECTRONICS CORPORATION |
ANDREW WHELAN |
| K163395 |
02/10/2017 |
Astroglide Diamond Silicone Gel Personal Lubricant |
BioFilm, Inc. |
Richard Hines |
| DEN160048 |
02/14/2017 |
FilmArray NGDS Warrior Panel |
BioFire Defense, LLC |
Cynthia Phillips |
| K162827 |
02/23/2017 |
VIDAS B.R.A.H.M.S. PCT (PCT) |
bioMerieux, Inc |
John Albright |
| K161510 |
02/13/2017 |
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) |
BIOMERIEUX, INC |
CHERECE L. JONES |
| K161437 |
02/16/2017 |
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) |
BIOMERIEUX, INC. |
KAREN RUSSELL |
| K172731 |
12/08/2017 |
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K172944 |
12/19/2017 |
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL |
bioMerieux, Inc. |
Cherece L. Jones |
| K163083 |
02/01/2017 |
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) |
bioMerieux, Inc. |
Mary Beth Anheuser |
| K173374 |
12/13/2017 |
TSV BellaTek Encode Healing Abutments |
Biomet 3i |
Nichole OÆNeil |
| K163651 |
02/17/2017 |
ExpressBraid Graft Manipulation |
Biomet Manufacturing Corp. |
Vinay Bhal |
| K170138 |
12/26/2017 |
NEURONAUTE |
BIOSERENITY |
Quang TRAN |
| K171185 |
12/01/2017 |
IR Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K172311 |
12/15/2017 |
BioFlux Device |
Biotricity Inc. |
Spencer LaDow |
| K162860 |
02/13/2017 |
MCS Bone Graft |
BIOVENTUS LLC |
John Brunelle |
| K163126 |
02/22/2017 |
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) |
Blue Sail Medical Co., Ltd |
Robin Liu |
| K162014 |
02/06/2017 |
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) |
BLUEPOINT MEDICAL GMBH & CO. KG |
BERND LINDNER |
| K172330 |
12/21/2017 |
Blustone Synergy Silica System |
Blustone Synergy |
Lisa Peterson |
| K172565 |
12/20/2017 |
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device |
Boston Scientific Corporation |
Anand Patel |
| K163272 |
02/18/2017 |
AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Kayla Mackey |
| K173251 |
12/19/2017 |
LumiCoil Platinum Fiducial Marker |
Boston Scientific Corporation |
Lindsay Forys |
| K171271 |
12/15/2017 |
Polyform Synthetic Mesh |
Boston Scientific Corporation |
Michelle Berry |
| K162771 |
02/24/2017 |
EkoSonic Endovascular System with Control Unit 4.0 |
BTG International, Inc. |
CURTIS JENSEN |
| K163165 |
02/16/2017 |
AM-100 |
BTL INDUSTRIES, INC |
David Chmel |
| K172932 |
12/13/2017 |
True Flow Valvuloplasty Perfusion Catheter |
C. R. Bard, Inc. |
Aaron Conovaloff |
| K163380 |
02/13/2017 |
Serranator Alto PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K173652 |
12/28/2017 |
Piccolo Composite Nailing System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K161607 |
02/23/2017 |
VISULUX |
CARL ZEISS MEDITEC AG |
Christian Muenster |
| K161415 |
02/10/2017 |
SteriTite Containers System & MediTray Products |
CASE MEDICAL, INC. |
TANIA LUPU |
| K161848 |
02/23/2017 |
Family of Steam sterilizers B17 B22 Series |
CEFLA S.C. |
Silvia Sansavini |
| DEN160016 |
02/06/2017 |
Variola virus Real-Time PCR Assay |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
YON YU |
| K162456 |
02/13/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
SCOTT A. CAMPBELL |
| K171552 |
12/19/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
Yi-Ping Lin |
| K162331 |
02/09/2017 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
SCOTT A. CAMPBELL |
| K171186 |
12/08/2017 |
Cerebrotech CMS-5000 |
Cerebrotech Medical Systems |
Dawnel Scott |
| K171956 |
12/12/2017 |
Sterile Endoscope Biopsy Sampling Needle |
Changzhou Detain Medical Devices Co., Ltd. |
Zhengrong Ding |
| K172561 |
12/05/2017 |
Disposable Circular Stapler |
Changzhou Kangdi Medical Stapler Co., Ltd. |
Eve Zhou |
| K162590 |
02/14/2017 |
Bashan TDP Heat Lamp |
Chogqing YUHE Medical Instruments Co., Ltd. |
Liu Yong |
| K171877 |
12/21/2017 |
SLM-1ER, SLM-2ER, SLM-3ER |
Chongqing Kanghua Ruiming S&T Co., Ltd. |
Xi You |
| K161764 |
02/16/2017 |
SLIT LAMP, Model: YF-100 |
CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD |
BING HU |
| K170163 |
02/14/2017 |
Erisma« LP Spinal Fixation System |
CLARIANCE SAS |
Pascal ROKEGEM |
| K172465 |
12/15/2017 |
IdysÖ TLIF 3DTi Cages |
CLARIANCE, SAS |
Pascal Rokegem |
| K171677 |
12/08/2017 |
Clear Guide SCENERGY |
Clear Guide Medical |
Jack Kent |
| K163214 |
02/07/2017 |
Unicare System, Unicare Manipulator |
ClearPath Surgical, Inc. |
Puja Ohlhaver |
| K173148 |
12/01/2017 |
ACIF |
coLigne, AG |
Robert Lange |
| K162158 |
02/09/2017 |
Porcine Anorganic Bone Mineral in Delivery Applicator |
Collagen Matrix, Inc. |
Peggy Hansen |
| K171043 |
12/21/2017 |
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters |
Coloplast Corp |
Cori Ragan |
| K172986 |
12/19/2017 |
Zmachine Synergy |
Consolidated Research of Richmond, Inc. dba General Sleep Co |
Richard Kaplan |
| K170193 |
02/13/2017 |
Advance 14LP Low Profile PTA Balloon Dilatation Catheter |
COOK INCORPORATED |
DANIEL J. CORBIN |
| K172217 |
12/13/2017 |
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath |
Cook Incorporated |
Andrew Breidenbach |
| K160200 |
02/17/2017 |
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set |
COOK INCORPORATED |
Kotei Aoki |
| K171275 |
12/20/2017 |
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design |
Cook Incorporated |
Daniel J. Corbin |
| K170008 |
02/28/2017 |
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set |
COOK INCORPORATED |
ERUM B. NASIR |
| K173685 |
12/20/2017 |
Peel-Away Introducer Set |
Cook Incorporated |
Colin Jacob |
| K172321 |
12/21/2017 |
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters |
Cook Incorporated |
Naomi Funkhouser |
| K173687 |
12/15/2017 |
Strange Bile Duct Stone Exploration Set |
Cook Incorporated |
Colin Jacob |
| K170898 |
12/12/2017 |
Wittich Nitinol Stone Basket |
Cook Incorporated |
Erum B. Nasir |
| K163169 |
02/07/2017 |
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent |
COOK IRELAND LTD |
Charlene Ryan |
| K172707 |
12/05/2017 |
Renamel Microfill |
Cosmedent, Inc |
Mary Nowak |
| K163480 |
02/24/2017 |
Renamel NANO +plus |
Cosmedent, Inc |
Hiren Patel |
| K172482 |
12/15/2017 |
The Nellcor pulse oximetry monitor interface cable |
Covidien |
Mia M. Ware |
| K170170 |
02/16/2017 |
Valleylab FT10 Electrosurgical Platform |
Covidien llc |
Sharon McDermott |
| K172432 |
12/12/2017 |
SporView Rapid Read Biological Indicator |
Crosstex/SPSmedical, A Division of Cantel Medical |
Megan Skaar |
| K172085 |
12/04/2017 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K162388 |
02/03/2017 |
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) |
CURASEAL, INC. |
HAROLD F. CARRISON |
| K162697 |
02/10/2017 |
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal |
Custom Orthopaedic Solutions, Inc. |
Keith Grafmeyer |
| K171909 |
12/17/2017 |
HAL for Medical Use (Lower Limb Type) |
CYBERDYNE Inc. |
Yohei Suzuki |
| K170005 |
12/21/2017 |
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) |
DAKO DENMARK A/S |
LASSE POST MOLLER |
| K170028 |
12/21/2017 |
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) |
DAKO DENMARK A/S |
Lasse Post Moller |
| K171530 |
12/21/2017 |
Deltaven XiV Max, Deltaven XiV Max FF |
Delta Med SpA |
Raschi Olga |
| K162888 |
02/24/2017 |
Cercon |
Dentsply Sirona |
Karl Nittinger |
| K163155 |
02/03/2017 |
MTM Clear Aligner |
DENTSPLY SIRONA |
HELEN LEWIS |
| K161213 |
02/10/2017 |
XSmart iQ |
DENTSPLY SIRONA |
HELEN LEWIS |
| K163046 |
02/09/2017 |
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long |
DEPUY SYNTHES |
JOANNA RIEDER |
| K161987 |
02/21/2017 |
UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure |
DIO CORPORATION |
SANGIN PARK |
| K162849 |
02/16/2017 |
Huvex Interspinous Fixation System |
DIO MEDICAL CO., LTD. |
LEE SUNG-HEE |
| K170104 |
12/27/2017 |
COMPACT S, COMPACT S (LED) |
DMETEC CO., LTD. |
Lee Seung Dae |
| K163535 |
02/22/2017 |
my Patch sl |
DMS-SERVICE LLC |
LYNDA COLE |
| K162283 |
02/06/2017 |
DCM Kyphoplasty System |
Dragon Crown Medical Co., Ltd. |
Zhi Yong Song |
| K171729 |
12/13/2017 |
Fixtemp C&B |
Dreve Dentamid GmbH |
Reiner Altmann |
| K162670 |
02/23/2017 |
RSM 1824C with RConsole1 |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K171174 |
12/18/2017 |
PERIO-FLOW nozzle |
E.M.S. Electro Medical Systems S.A. |
Suzanne Fassio-Hardy |
| K160876 |
02/15/2017 |
PC ECG |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K161056 |
02/03/2017 |
Telemetry Transmitter |
Edan Instruments, Inc. |
Queena Chen |
| K162071 |
02/24/2017 |
IllumiFlow Laser Cap |
EGLOBAL, LLC |
WAYNE DESTEFANO |
| K172888 |
12/15/2017 |
EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K172270 |
12/07/2017 |
gammaCore-2 |
eletroCore, LLC |
Mike Romaniw |
| K173073 |
12/26/2017 |
AltiVate Anatomic to Reverse Conversion Module |
Encore Medical, L.P. |
Teffany Hutto |
| K172651 |
12/13/2017 |
FMP Extended Liners |
Encore Medical, L.P. |
Teffany Hutto |
| K161715 |
02/07/2017 |
EndyGel |
EndyMed Medical Ltd. |
Yoram Levy |
| K163038 |
02/28/2017 |
EPIC Extremity Snap-Off Screw |
EPIC EXTREMITY, LLC |
DAN SCHWARTZBAUER |
| K163548 |
02/14/2017 |
ENSEAL X1 Large Jaw Tissue Sealer |
Ethicon Endo-Surgery, LLC |
Marjorie Medina |
| K172722 |
12/10/2017 |
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) |
EUROIMMUN US, Inc. |
Michael A. Locke |
| K172357 |
12/29/2017 |
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow |
EVER GROWTH (VIETNAM) CO., LTD |
Che-Min Lee |
| K171781 |
12/13/2017 |
eVox System |
Evoke Neuroscience, Inc. |
David Hagedorn |
| K173375 |
12/21/2017 |
Anterior Cervical Plate System |
Evolution Spine, LLC |
Douglas Davis |
| K162903 |
02/27/2017 |
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies |
Exactech Inc |
Thomas McNamara |
| K162726 |
02/01/2017 |
Exactech« Equinoxe« Preserve Stem |
EXACTECH INC |
Thomas McNamara |
| K170240 |
02/23/2017 |
Truliant Femoral Components |
Exactech Inc |
Patrick Hughes |
| K162508 |
02/13/2017 |
KerraCel Ag Gelling Fiber Silver Dressing |
Exciton Technologies Inc. |
Melanie Ussyk |
| K172960 |
12/21/2017 |
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use |
Ezisurg Medical Co., Ltd. |
Sheng Tian |
| K171193 |
12/18/2017 |
Certa Catheter |
Ferrosan Medical Devices SP. Z O.O. |
Elzbieta Porebska-Guillemant |
| K163416 |
02/16/2017 |
Fiagon Navigation û PointerTube Straight and PointerTube Keat |
FIAGON GMBH |
DIRK MUCHA |
| K163440 |
02/01/2017 |
Stealth Staple System |
FIRST RAY LLC |
ROBERT HOY |
| K162987 |
02/14/2017 |
FA100 SCCD (Sequential Continuous Contraction Device) |
FlowAid Medical Technologies, Corp |
Jacob Brezel |
| K163085 |
02/14/2017 |
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack |
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC |
Irene M. Guzman |
| K172819 |
12/01/2017 |
LightWalker Laser System Family |
Fotona d.o.o. |
Marko Berdajs |
| K172238 |
12/14/2017 |
CAREline Airless Hemodialysis Blood Tubing Sets |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K172713 |
12/10/2017 |
Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K161980 |
02/07/2017 |
Fuselier Intraoral Nighttime Device (FIND) |
FUSELIER ENTERPRISES, LLC |
BRIAN FUSELIER |
| K171834 |
12/19/2017 |
G Surgical OCT Spinal System |
G Surgical LLC |
Donald Grafton |
| K173287 |
12/21/2017 |
Elite HV Radial |
Galt Medical Corp. |
David Derrick |
| K173555 |
12/20/2017 |
LOGIQ E10 |
GE Healthcare |
Bryan Behn |
| K163596 |
02/10/2017 |
LOGIQ P9 and LOGIQ P7 |
GE HEALTHCARE |
BRYAN BEHN |
| K173612 |
12/11/2017 |
Optima XR646 HD |
GE Hualun Medical Systems Co., Ltd |
Kenny Ma |
| K163619 |
02/14/2017 |
SIGNA PET/MR |
GE Medical Systems, LLC |
Janice M. Sich |
| K172010 |
12/07/2017 |
gel-e Bandage |
gel-e, Inc. (formerly Remedium Technologies, Inc.) |
Matthew Dowling |
| K170276 |
12/11/2017 |
Safety Blood Collection Device for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| K172714 |
12/08/2017 |
LipiVage |
Genesis Biosystems, Inc. |
Jim Lafferty |
| K161316 |
02/23/2017 |
George King Coumadin Plasma |
GEORGE KING BIO-MEDICAL, INC. |
BARBARA YOUNG |
| K171108 |
12/29/2017 |
AUTOBAHN Nailing System |
Globus Medical Inc. |
Kelly J. Baker |
| K173115 |
12/20/2017 |
COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS |
Globus Medical Inc. |
Kelly J. Baker |
| K171848 |
12/21/2017 |
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS |
Globus Medical Inc. |
Lori Burns |
| K152022 |
02/22/2017 |
SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers |
GLOBUS MEDICAL INC. |
KELLY J. BAKER |
| K172445 |
12/08/2017 |
RoyalGuard Surgical Gown, i600, Breathable |
GRI Medical & electrical Technology Co., Ltd |
Martin D. Paugh |
| K163191 |
02/27/2017 |
ComfortGuard Surgical Gown, i600, Film Reinforced |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
Martin D. Paugh |
| K163550 |
12/20/2017 |
Pobling MIITY 2 |
HABALAN MED & BEAUTY CO.,LTD |
RAY JEON |
| K162073 |
02/24/2017 |
Dental Implants OKTAGON Tissue Level and Bone Level |
HAGER & MEISINGER GMBH |
MELANIE MAY |
| K172861 |
12/19/2017 |
Digital thermometer(with disposable thermometer cover) |
Hangzhou Hua'an medical&health instruments Co.,Ltd |
Ahneo Yang |
| K162923 |
02/06/2017 |
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DR |
HARTALEGA NGC SDN. BHD. |
KUAN MUN LEONG |
| K173137 |
12/12/2017 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K162491 |
02/08/2017 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K162683 |
02/03/2017 |
RehaStim 2 |
HASOMED GmbH |
Matthias Ueltzen |
| K163146 |
02/13/2017 |
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
Shaozhang Nan |
| K163168 |
02/23/2017 |
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) |
HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED |
Liu Wei |
| K171336 |
12/07/2017 |
Cystoscope 4.0mm autoclavable 0░ WL 302mm; Hysteroscope 4.0mm autoclavable 0░ WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath |
Henke-Sass, Wolf GmbH |
Anna Reifschneider |
| K171049 |
12/26/2017 |
Real Time Image Gating System for Proton Beam Therapy Systems |
Hitachi, Ltd. Healthcare |
Tomoyuki Seino |
| K172629 |
12/04/2017 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
Anila K Tarte |
| K170988 |
12/12/2017 |
DropSafe Safety Pen Needle |
HTL-Strefa S.A. |
Aleksandra Prazmowska-Wilanowska |
| K173131 |
12/08/2017 |
Rexious Spinal Fixation System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K171480 |
12/13/2017 |
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| DEN160062 |
12/19/2017 |
IlluminOss Bone Stabilization System |
IllminOss Medical, Inc. |
Fred Tobia |
| K173038 |
12/01/2017 |
CuRAS Nd:YAG Laser |
Ilooda Co., Ltd. |
Yun-Jung HA |
| K170202 |
02/22/2017 |
Aquarius 8600 |
IMAGING DYNAMICS COMPANY LTD. |
Nicole Wherry |
| K163260 |
02/17/2017 |
SeptiCyte LAB |
IMMUNEXPRESS, INC. |
VICTORIA ROTHWELL |
| K170209 |
02/23/2017 |
ImPACT |
IMPACT APPLICATIONS, INC |
MICHAEL ZAGORSKI |
| K172507 |
12/22/2017 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K173470 |
12/04/2017 |
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
Eben Gordon |
| K163549 |
02/16/2017 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Eben Gordon |
| K170881 |
12/14/2017 |
ISP Safety Huber Needle Infusion Set |
Infusion Safety Products, Inc. |
Alan P. Reid |
| K173126 |
12/05/2017 |
ArisstosÖ Spinal System |
Ingenium Spine |
David Brumfield |
| K172302 |
12/08/2017 |
InMode PLUS System |
InMode MD Ltd. |
Amit Goren |
| K172468 |
12/06/2017 |
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm |
InNeuroCo, Inc |
Marc Litzenberg |
| K162099 |
02/15/2017 |
IBS Implant System II |
InnoBioSurg Co., Ltd. |
Bo-reum Yoo |
| K161258 |
02/03/2017 |
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
| K170993 |
12/22/2017 |
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
Inova Diagnostics, Inc. |
Roger Albesa |
| K171773 |
12/01/2017 |
Straumann n!ce Glass Ceramic A14 Blocks |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K162753 |
02/28/2017 |
RTC 26-C Inline Aerosol Adapter |
INSTRUMENTATION INDUSTRIES, INC. |
Doris Walter |
| K173403 |
12/29/2017 |
GEM Premier 5000 |
Instrumentation Laboratory Co. |
Carol Marble |
| K163056 |
02/24/2017 |
RevolutionÖ Spinal Fixation System |
Intelligent Implant Systems, LLC |
Michael Nutt |
| K170029 |
12/15/2017 |
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile |
INTERNATIONAL BIOPHYSICS CORPORATION |
Geoff Marcek |
| K162624 |
02/01/2017 |
Pre-Formed Penile Silicone Block |
INTERNATIONAL MEDICAL DEVICES, INC. |
JAMES ELIST |
| K162973 |
02/06/2017 |
EndoWrist Suction Irrigator |
Intuitive Surgical, Inc. |
Melissa S. Gonzalez |
| K161579 |
02/24/2017 |
Watch-PAT200U |
ITAMAR MEDICAL, LTD. |
Koby Sheffy |
| K171102 |
12/21/2017 |
Ives MR Conditional Cup Electrode |
Ives EGG Solutions |
John Ives |
| K171012 |
12/19/2017 |
Veraview X800 |
J.Morita USA, Inc. |
Keisuke Mori |
| K170105 |
02/28/2017 |
Jac-Cell Medic testers |
JAC-CELL MEDIC |
MARK MELTZER |
| K172008 |
12/01/2017 |
ARIX Humerus System |
Jeil Medical Corporation |
Sejin Ryu |
| K161335 |
02/23/2017 |
Dual Top Screw System |
JEIL MEDICAL CORPORATION |
SEUNGYOUNG LEE |
| K170846 |
12/13/2017 |
Disposable Insulin Pen Needle |
Jiangsu Caina Technology Co., Ltd. |
Jun Lu |
| K172989 |
12/20/2017 |
Electric Breast Pump |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K160918 |
02/13/2017 |
JUVORA Dental Disc, Ceramill PEEK by JUVORA |
JUVORA |
SELINA SALTHOUSE |
| K173434 |
12/14/2017 |
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 |
JVC KENWOOD Corporation |
Masafumi Yugami |
| K172009 |
12/14/2017 |
Cascadia Interbody System |
K2M, Inc. |
Nancy Giezen |
| K163317 |
02/21/2017 |
ELECTROmatic |
Kaltenbach & Voigt GmgH |
Stefan Trampler |
| K172918 |
12/18/2017 |
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
KaVo Dental Technologies, LLC |
Frank Ray |
| K162536 |
02/03/2017 |
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord |
KERR CORPORATION |
MOHAMMAD SAAD ANSARI |
| K171748 |
12/14/2017 |
Vitrification Kit and Thawing Kit |
Kitazato Corporation |
Futoshi Inoue |
| K160610 |
02/13/2017 |
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set |
KOBOLD, LLC |
Brian Stoddart |
| K173696 |
12/19/2017 |
TBL-ABI System |
LD Technology LLC |
Albert Maarek |
| DEN140033 |
02/16/2017 |
Companion |
LGCH, INC |
Mike Girouard |
| K162106 |
02/03/2017 |
Micro-current Wrinkle Reduction Facial service, model EP-400 |
Li-Tek Electronic Technology Corporation |
Barry Yuan |
| K163173 |
02/08/2017 |
Handheld Diode Laser for Hair Removal |
Liaoning Sidey Optoelectronics Technologies Co., Ltd. |
Li Zhao |
| K173286 |
12/14/2017 |
Cannulated Screw Internal Fixation System |
Life Spine Inc. |
Randy Lewis |
| K172973 |
12/21/2017 |
Life Spine Foot and Ankle Plating System |
Life Spine Inc. |
Randy Lewis |
| K161279 |
02/01/2017 |
Life Spine Metatarsal Hemi Implant |
LIFE SPINE INC. |
RANDY LEWIS |
| K173182 |
12/20/2017 |
ProLift« Expandable System |
Life Spine Inc. |
Randy Lewis |
| K162752 |
02/24/2017 |
ARTIA Reconstructive Tissue Matrix Perforated |
LIFECELL CORPORATION |
ANUJA YARDI |
| K170046 |
12/07/2017 |
Lilium a-200E |
Lilium Otsuka Co., Ltd. |
Hiroaki Takahashi |
| K161226 |
02/10/2017 |
Revision Femoral Stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K161120 |
02/21/2017 |
SMR TT Metal Back Glenoid, Bone Graft instruments |
LIMACORPORATE S.P.A. |
Emanuele Buttazzoni |
| K173484 |
12/11/2017 |
CorticaLINK Spinal Fusion Platform |
LinkSPINE Inc |
Nickolas Kriska |
| K163298 |
02/22/2017 |
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K173307 |
12/19/2017 |
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K162852 |
02/08/2017 |
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove |
Lucenxia Prescience AG |
Robert Hill |
| K162837 |
02/28/2017 |
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532Ö Laser System |
LUMENIS LTD |
NAAMA JACOBY |
| K172737 |
12/12/2017 |
MESIRE - Balloon Sinus Dilatation System |
M/s. Meril Life Sciences Private Limited |
Umesh Sharma |
| K163282 |
02/28/2017 |
Apex Dental Sensors |
Masterlink LLC |
Tom Birney |
| K172844 |
12/15/2017 |
Cellvizio 100 Series System with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K171928 |
12/08/2017 |
Med-Hot Thermal Imaging Systems |
Med-Hot Thermal Imaging Inc. |
Carol Chandler |
| K173267 |
12/07/2017 |
MasterLoc Stem: Lateralized Plus |
Medacta International SA |
Stefano Baj |
| K171058 |
12/13/2017 |
Medacta Shoulder System: Threaded Glenoid Baseplate |
Medacta International SA |
Stefano Baj |
| K161861 |
02/09/2017 |
APTUS« Coronoid 2.0 |
Medartis AG |
Andrea Schweizer |
| K171483 |
12/15/2017 |
ArchFlo CT Midline |
Medcomp (dba Medical Components, Inc.) |
Courtney Nix |
| K161811 |
02/15/2017 |
Medela Low Dose Enteral Syringe |
Medela, Inc. |
Fergie Ferguson |
| K170103 |
02/16/2017 |
Laparoscope Lens Shield Device (LENS) |
Medeon Biodesign, Inc |
Greta Chang |
| K160358 |
02/24/2017 |
DT-100 |
Mediana Co., Ltd. |
Min-hye Kim |
| K170497 |
12/15/2017 |
V10 |
Mediana Co., Ltd. |
Kim Min-hye |
| K163091 |
02/21/2017 |
VibraPEP |
Medica Holdings, LLC |
George Reed |
| K170934 |
12/06/2017 |
C3 Wave System |
Medical Components, Inc (Dba Medcomp_ |
Courtney Nix |
| K160837 |
02/23/2017 |
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM |
MEDINET SRL |
STEFANO BERNUCCI |
| K163688 |
02/23/2017 |
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 |
MEDISONO, LLC |
JORGE MILLAN |
| K172677 |
12/19/2017 |
Advantage Plus Pass-Thru |
Medivators Inc. |
Megan Skaar |
| K162982 |
02/27/2017 |
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Jennifer Mason |
| K163268 |
02/02/2017 |
FlexCath Select Steerable Shealth and Dilator |
Medtronic CryoCath LP |
Natalie Sadeghi |
| K163032 |
02/27/2017 |
Kyphon Xpede Bone Cement |
Medtronic Inc. |
Pamela Edwards |
| K173664 |
12/29/2017 |
Medtronic O-arm O2 Imaging System |
Medtronic Inc. |
Dean Honkonen |
| K173125 |
12/20/2017 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek |
Kanesha Hines |
| K163279 |
02/23/2017 |
Medtronic Transportation/Sterilization Cassettes |
Medtronic Sofamor Danek, USA, Inc. |
Julie Bassett |
| K171866 |
12/20/2017 |
Sentrant Introducer Sheath with Hydrophilic Coating |
Medtronic Vascular, Inc. |
Wee Wen Leow |
| K163008 |
02/28/2017 |
CareLink SmartSync Device Manager - Pacing System Analyzer |
Medtronic, Inc. |
Laura Danielson |
| K162774 |
02/10/2017 |
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) |
Medtronic, Inc. |
Harsh Dharamshi |
| K162958 |
02/01/2017 |
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge |
Medtronic, Inc. |
Harsh Dharamshi |
| K162855 |
02/23/2017 |
Reveal LINQ |
Medtronic, Inc. |
Syed Sumran Mohiuddin |
| K163460 |
02/14/2017 |
Reveal LINQ Insertable Cardiac Monitor |
MEDTRONIC,INC. |
Laura Danielson |
| K171109 |
12/21/2017 |
Praxiject 0.9% NaCl |
MedXL Inc. |
Premala Premanathan |
| K170389 |
12/14/2017 |
TAURUS PEEK Cage System |
Medyssey USA, Inc. |
Shawn Kim |
| K172756 |
12/08/2017 |
Varian cage |
Medyssey USA, Inc. |
Shawn Kim |
| K173475 |
12/08/2017 |
Merge PACS |
Merge Healthcare Incorporated |
Carol Nakagawa |
| K163273 |
02/21/2017 |
TRU Legionella |
MERIDIAN BIOSCIENCE, INC. |
Lauren Davis |
| K173621 |
12/13/2017 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| K173124 |
12/18/2017 |
PEEK Biosolution |
Merz Dental GmbH |
Claudia Bobrowski |
| K172848 |
12/27/2017 |
MEVION S250i Proton Beam Radiation Therapy Device |
Mevion Medical Systems |
Thomas H. Faris |
| K172786 |
12/08/2017 |
MDS Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K161372 |
02/24/2017 |
The Red Head Collection Device, The Jordy Connection System |
MIAMI FAT SUPPLY |
Donnell Mark Jordan |
| K172448 |
12/21/2017 |
Riptide Aspiration System |
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
Ryan Kenney |
| K161500 |
02/22/2017 |
MEG-TORQ |
MICRO-NX Co., Ltd |
J. K. Jung |
| K173420 |
12/27/2017 |
Radiomics App v1.0 |
Microsoft Corp. |
Ivan Tarapov |
| K162570 |
02/16/2017 |
Miromatrix Biological Mesh TW |
Miromatrix Medical Inc. |
Jeff Ross |
| K172505 |
12/28/2017 |
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K170165 |
12/29/2017 |
Osteo-P Bone Graft Substitute |
Molecular Matrix, Inc. |
Charles Lee |
| K173492 |
12/22/2017 |
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software |
MolecularMD Corporation |
Kevin Hawkins |
| K173392 |
12/12/2017 |
Pure-Vu System |
Motus GI Medical Technologies Ltd. |
Hagit Ephrath |
| K173043 |
12/14/2017 |
Holycon Synthetic Absorbable Sutures |
Nantong Holycon Medical Devices Co., Ltd. |
Feng Lu |
| K172743 |
12/19/2017 |
Natus VikingQuest |
Natus Neurology Incorporated |
Shane T. Sawall |
| K163452 |
02/03/2017 |
PICC Maximal Barrier Nursing Kit |
Navilyst Medical, Inc. |
Robin Fuller |
| K161534 |
02/22/2017 |
EasyOne Pro Respiratory Analysis System |
NDD MEDIZINTECHNIK AG |
N/A N/A |
| K153262 |
02/07/2017 |
PUREtraceÖ |
NEMO HEALTHCARE BV |
Aron Wierts |
| K173087 |
12/28/2017 |
UroLift System (UL400 and UL500) |
NeoTract, Inc. |
Louis-Pierre Marcoux |
| K171198 |
12/07/2017 |
NeuViz 16 Essence Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Shao Xiancheng |
| K161860 |
02/24/2017 |
TG-970P CO2 Sensor Kit |
NIHON KOHDEN CORPORATION |
THOMAS BENTO |
| K160444 |
02/08/2017 |
FB-U Hemodialyzer |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
| K172854 |
12/14/2017 |
NobelPerfect Abutments |
Nobel Biocare AB |
Charlemagne Chua |
| K161655 |
02/28/2017 |
On1 Concept |
NOBEL BIOCARE AB |
CHARLEMAGNE CHUA |
| K162875 |
02/17/2017 |
Sentry IVC filter |
NOVATE MEDICAL LTD. |
GORDON CROWLEY |
| K173129 |
12/01/2017 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K173117 |
12/07/2017 |
NuVasive« VersaTieÖ System |
NuVasive, Inc. |
Marysa Loustalot |
| K172623 |
12/21/2017 |
NuVasive Navigation Instruments |
NuVasive, Incorporated |
Manthan J. Damani |
| K172676 |
12/14/2017 |
NuVasive« Modulus-C Interbody System |
NuVasive, Incorporated |
Marysa E. Loustalot |
| K173153 |
12/06/2017 |
Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System |
NuVasive, Incorporated |
Michelle Cheung |
| K173091 |
12/06/2017 |
Boundary Anterior Lumbar Buttress Plate |
Nvision Biomedical Technologies, LLC |
Diana L. Langham |
| K172734 |
12/07/2017 |
Single Use Electrosurgical Snare SD-400 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172618 |
12/05/2017 |
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172467 |
12/21/2017 |
OMNI ARC Anteverted Neck Hip Stem |
OMNIlife science |
Christina Rovaldi |
| K163045 |
02/21/2017 |
Omron HEM-6400T-Z Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
Renee Thornborough |
| K171167 |
12/13/2017 |
Prodigio Stain Powder |
OperArt LLC |
Domenico Cascione |
| K162039 |
02/08/2017 |
OptosAdvance 4.0 Software |
Optos Plc |
Paul Burns |
| K163566 |
02/09/2017 |
Hubble I System |
Orbbo Surgical, LLC. |
Eric Garofano |
| K163602 |
02/16/2017 |
Kepler I Cervical Plate System |
Orbbo Surgical, LLC. |
Eric Garofano |
| K162833 |
02/16/2017 |
VitriGuard |
ORIGIO A/S |
ROAIDA JOHNSON |
| K173458 |
12/07/2017 |
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
Orthofix Srl |
Gianluca Ricadona |
| K172425 |
12/06/2017 |
OrthoPediatrics Wrist Fusion Plate |
OrthoPediatrics, Inc. |
Adam Cargill |
| K172573 |
12/15/2017 |
ReBOSSIS85 |
Orthorebirth Co., Ltd. |
Yasutoshi Nishikawa |
| K171269 |
12/28/2017 |
X-PSI Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Guylaine Roy |
| K170972 |
12/20/2017 |
Apex Tibial Nailing System |
OrthoXel |
Aisling O'Sullivan |
| K161103 |
02/02/2017 |
US SA Implant System |
OSSTEM IMPLANT CO.,LTD. |
Hee Kwon |
| DEN160014 |
12/22/2017 |
remOVE System |
OVESCO ENDOSCOPY AG |
Med.Marc O. Schurr |
| K173646 |
12/19/2017 |
FS Ergo |
PaloDEx Group Oy |
Anni Lundholm |
| K172886 |
12/20/2017 |
Breakaway Screw System |
Paragon 28 |
Eric Lintula |
| K170086 |
02/09/2017 |
Pinnacle Radiation Therapy Planning System |
Philips Medical Systems (Cleveland), Inc. |
Michelle Godin |
| K170113 |
02/09/2017 |
pixium 4343RCE |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K173467 |
12/12/2017 |
Advanced Diffusion Analysis (ADA) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K162484 |
02/23/2017 |
Lung Nodule Assessment and Comparison Option (LNA) |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K172904 |
12/26/2017 |
IntelliVue Capnography Extension, IntelliVue Microstream Extension |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K172349 |
12/14/2017 |
InFill« Interbody Fusion Device |
Pinnacle Spine Group, LLC |
Zach Sowell |
| K163328 |
12/28/2017 |
Planmed Clarity |
Planmed Oy |
Lars Moring |
| K173130 |
12/19/2017 |
Reform« Midline Cortical Screw System |
Precision Spine, Inc. |
Michael C. Dawson |
| K170061 |
02/02/2017 |
ProMISÖ Fixation System |
Premia Spine Ltd. |
Kobi Arbus |
| K172893 |
12/21/2017 |
SafeSept Needle Free Transseptal Guidewire |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K161025 |
02/03/2017 |
priti multidisc ZrO2 High Translucent |
PRITIDENTA GMBH |
MAGDALENA GEIGENBERGER |
| DEN170024 |
12/21/2017 |
AQUABEAM System |
PROCEPT BioRobotics Corporation |
Michael Nketiah |
| K163374 |
02/16/2017 |
ALLYÖ Facet Screws |
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
MARGARET WONG |
| K161099 |
02/23/2017 |
Powder Free Nitrile Examination Gloves, Black |
PT. MAJA AGUNG LATEXINDO |
IMELDA SHAMROCK |
| K163041 |
02/22/2017 |
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E |
PT. MEDISAFE TECHNOLOGIES |
DEEPAK BANG |
| K172056 |
12/13/2017 |
InnoSight Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K173002 |
12/13/2017 |
2940 nm Er:Yag Laser Handpiece |
Quanta System S.p.A. |
Francesco DellÆAntonio |
| K162911 |
02/22/2017 |
Sofia RSV FIA on Sofia 2 analyzer |
Quidel Corporation |
Edward C. Brehm |
| K171976 |
12/21/2017 |
Sofia Strep A+ FIA, Sofia 2 Analyzer |
Quidel Corporation |
Edward C. Brehm |
| K173250 |
12/21/2017 |
Solana GBS Assay |
Quidel Corporation |
Ronald H. Lollar |
| K171352 |
12/01/2017 |
EZFluence |
Radformation, Inc. |
Kurt Sysock |
| K161334 |
02/09/2017 |
RASL Repair Kit |
RADICLE ORTHOPAEDICS, INC. |
EDWARD ROSENWASSER |
| K162481 |
02/16/2017 |
RF1400 Active Compression Wrap |
RECOVERY FORCE LLC |
Jeff Schwegman |
| K173662 |
12/20/2017 |
speX Support Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K173102 |
12/29/2017 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K161411 |
02/17/2017 |
Care Cycle Connect Application |
RESPIRONICS, INC. |
Colleen Witt |
| K162321 |
02/10/2017 |
EasyClip Xpress |
RESTORE SURGICAL LLC dba Instratek |
JEFF SEAVEY |
| K170373 |
02/27/2017 |
Flextra Steerable Introducer |
Rhythm Xience, Inc. (RXI) |
James Hassett |
| K172503 |
12/01/2017 |
MR Conditional Cup Electrode, MR Conditional Webb Electrode |
Rhythmlink International, LLC |
Daniel McCoy |
| K170960 |
12/25/2017 |
CoaguChek Vantus System |
Roche Diagnostics |
Justin Davis |
| K162840 |
02/08/2017 |
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 |
Roche Diagnostics |
Linda McCammack |
| K163184 |
02/09/2017 |
cobas« CT/NG v2.0 Test |
Roche Molecular Systems, Inc. |
David W. Gates |
| K170392 |
12/01/2017 |
S.I.N. Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denis Oliveira |
| K160799 |
02/17/2017 |
GenNarino |
SALIWELL LTD. |
BEN Z. BEISKI |
| K163691 |
02/22/2017 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Emily Woo |
| DEN160037 |
12/28/2017 |
dermaPACE System |
SANUWAVE, INC. |
PETER STEGAGNO |
| K161491 |
02/09/2017 |
Scopis Hybrid Navigation System EM |
Scopis GmbH |
Christopher Ozbek |
| K173260 |
12/04/2017 |
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e╖POD System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172926 |
12/21/2017 |
SeaSpine Vu cPOD, Zuma-C, Complete Cervical |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K162281 |
02/17/2017 |
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) |
SEBIA |
KAREN ANDERSON |
| K161577 |
02/08/2017 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
Ren Yunhua |
| K162565 |
02/18/2017 |
VIA 17 Microcatheter |
SEQUENT MEDICAL, INC. |
BETHANY BARRETT |
| K161521 |
02/16/2017 |
TAP Blood Collection Device |
Seventh Sense Biosystems, Inc. |
TIM RICHARDS |
| K173000 |
12/07/2017 |
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K162479 |
02/08/2017 |
Smart Pain Reliever, Model LT5019 |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
TRUMAN SHEN |
| K173462 |
12/08/2017 |
Wireless Pain Relieve Device Model: LT5018C |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K173369 |
12/13/2017 |
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Jean Lei |
| K171381 |
12/13/2017 |
Adhesive Electrodes |
ShenZhen Quality Medical Technology Co.,Ltd |
Grace Zhao |
| K172222 |
12/08/2017 |
8ch Flex Suite |
Shenzhen RF Tech Co., Ltd. |
Ke Xi |
| K172530 |
12/06/2017 |
BEAUTIFIL Flow Plus X |
Shofu Dental Corporation |
Mauro Malzyner |
| K172286 |
12/18/2017 |
Automated Blood Coagulation Analyzer CS-2500 |
Siemens Healthcare Diagnostic Products Gmbh |
Nils Neumann |
| K171771 |
12/04/2017 |
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K163285 |
02/14/2017 |
syngo Application Software |
SIEMENS MEDICAL SOLUTION USA, INC. |
PATRICIA D. JONES |
| K163478 |
02/09/2017 |
AcuNav Volume ICE Catheter |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K173618 |
12/19/2017 |
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K173578 |
12/20/2017 |
Biograph mCT Family of PET/CT Systems |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K163234 |
02/28/2017 |
Biograph mMR with syngo MR E11P system software |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173600 |
12/19/2017 |
MAGNETOM Amira |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K163341 |
02/09/2017 |
syngo.CT Extended Functionality |
SIEMENS MEDICAL SOLUTIONS USA, Inc. |
Kimberly Mangum |
| K163294 |
02/06/2017 |
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L. FIELDS |
| K163289 |
02/09/2017 |
syngo. CT Single Source Dual Energy (twin beam) |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
Kimberly Mangum |
| K173332 |
12/21/2017 |
OMNI Surgical System |
Sight Sciences, Inc. |
Anne-Marie Ripley |
| K171434 |
12/21/2017 |
ROCCIA« MultiLIF |
Silony Medical GmbH |
Bircan Yilmaz |
| K172688 |
12/22/2017 |
Align Radial Head System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K161629 |
02/10/2017 |
CRYLREX |
SM ENG CO., LTD |
SOON-GU LEE |
| K172876 |
12/04/2017 |
PowerDot PD-01M |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K172785 |
12/22/2017 |
CONQUEST FN |
Smith & Nephew |
Allison Chan |
| K170720 |
12/07/2017 |
Portex Blue Line Ultra Paediatric Tracheosomy Tube |
Smiths Medical ASD, Inc. |
James Taufen |
| K170862 |
12/19/2017 |
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope |
Solace Therapeutics, Inc. |
Scott Blood |
| K162402 |
02/16/2017 |
4CIS« Marlin ACIF Cage System |
SOLCO BIOMEDICAL CO., LTD. |
KIM IL |
| K161371 |
02/24/2017 |
Sonoma Fifth Metatarsal Repair System |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
Rick Epstein |
| K171935 |
12/01/2017 |
Alevicyn SG Antimicrobial Gel |
Sonoma Pharmaceuticals, Inc. |
Brian W. Martin |
| K173058 |
12/01/2017 |
P10 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K172993 |
12/05/2017 |
P20 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K170790 |
12/13/2017 |
SAM CRRT Unit, SAM Cassette CRRT |
Spectral Medical Inc. |
Danijela Domljanovic |
| K163428 |
02/02/2017 |
HA Minuteman G3-R MIS Fusion Plate |
Spinal Simplicity |
Douglas B Snell |
| K172594 |
12/15/2017 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K162639 |
02/07/2017 |
ProficientÖ Posterior Cervical Spine System |
Spine Wave, Inc. |
Sanja Jahr |
| K162760 |
02/16/2017 |
Spine Wave Anterior Cervical Spine System |
SPINE WAVE, INC. |
Amnon Talmor |
| K162611 |
02/09/2017 |
PeriFLEX |
SPIRATION, INC. |
Aadarsh S Viswanathan |
| K172474 |
12/29/2017 |
Celerity 20 HP Biological Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K161432 |
02/08/2017 |
MyNeWT Negative Pressure Wound Therapy System |
Stortford Medical LLC |
Chris Daughtery |
| K170091 |
02/09/2017 |
UA-Cellular Complete |
Streck |
Deborah Kipp |
| K162929 |
02/22/2017 |
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker |
Stryker Corporation |
Brittney M. Larsen |
| K162937 |
02/23/2017 |
Stryker OrthoMap Versatile Hip System |
Stryker Corporation |
Brittney Larsen |
| K172350 |
12/15/2017 |
AxSOS 3 Ti |
Stryker GmbH |
Kemine Hale |
| K162439 |
02/03/2017 |
AxSOS 3 Ti; Stryker Plating System |
STRYKER GMBH |
Irene Bacalocostantis |
| K162841 |
02/21/2017 |
VariAx Distal Radius Plating System, VariAx 2 System |
Stryker GmbH |
Irene Bacalocostantis |
| K161693 |
02/23/2017 |
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis |
STRYKER SUSTAINABILITY SOLUTIONS |
Scott English |
| K170913 |
12/15/2017 |
Composite Removable Sinus Stent System |
STS Medical |
Lena Shlossberg |
| K172982 |
12/19/2017 |
SuperGrow 272, Ultimate 272 |
Super Grow Lasers |
Jeff Stanifer |
| K162830 |
02/14/2017 |
SIS Software |
Surgical Information Sciences, Inc. |
Mark Headrick |
| K172978 |
12/22/2017 |
SurgeoBite |
Surgovations LLC |
Chris Menard |
| K161894 |
02/21/2017 |
SurgTech Trauma System |
SURGTECH INC |
XUEGONG YU |
| K172666 |
12/01/2017 |
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor |
SutureEase, Inc. |
Scott Heneveld |
| K171889 |
12/19/2017 |
Reusable Blood Pressure Cuff |
Suzhou Minhua Medical Apparatus Supplies Co., LTD |
Yang Qidong |
| K172560 |
12/21/2017 |
PREMIUM ONE Implant Systems |
Sweden & Martina S.p.A |
Alessia Pezzato |
| K172473 |
12/15/2017 |
LifeStyles« SKYN« Intimate Moments Personal Lubricant |
SXWELL USA LLC |
Robert Mahler |
| K162454 |
02/01/2017 |
PicoWay Laser System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K170818 |
12/07/2017 |
Craniomaxillofacial Distraction System (CMFD) |
Synthes USA Products, LLC |
Nicholas Fountoulakis |
| K161616 |
02/16/2017 |
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannu |
Synthes USA Products, LLC |
Nina Rudolph |
| K173536 |
12/12/2017 |
T2Candida 1.1 Panel |
T2 Biosystems, Inc. |
Anne Marie Whalen |
| K172692 |
12/13/2017 |
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens |
Tangible Science LLC |
Vic McCray |
| K172645 |
12/26/2017 |
iLux Instrument, iLux Disposable |
Tear Film Innovations, Inc. |
John Slate |
| K162965 |
02/16/2017 |
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction |
TEI Biosciences Inc. |
Kavita Amin |
| K173441 |
12/13/2017 |
Neurosoft TMS (also CloudTMS) |
TeleEMG, LLC |
Joe F. Jabre |
| K162989 |
02/24/2017 |
Rusch Simplastic Foley Catheters |
TELEFLEX MEDICAL, INC. |
LORI PFOHL |
| K162922 |
02/23/2017 |
GalaFORM 3D |
TEPHA, INC. |
CONNIE H GARRISON |
| K161953 |
02/17/2017 |
ReDe Mask |
TereoPneuma |
Warren G. Young |
| K162365 |
02/16/2017 |
T-Cuff |
Terumo BCT, Inc. |
Nithya Rajan |
| K161606 |
02/10/2017 |
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K162710 |
02/09/2017 |
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
TGS Medical Co., Ltd. |
Hua Cao |
| K173209 |
12/01/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K162800 |
02/22/2017 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER SAS |
Aymen AZAIEZ |
| K170019 |
02/02/2017 |
Aquilion Lightning, TSX-036A/1, V8.4 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172863 |
12/14/2017 |
Infinix-i, INFX-8000V, V7.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172276 |
12/12/2017 |
Xario 200 Diagnostic Ultrasound System V6.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173349 |
12/20/2017 |
Operio |
Toul Meditech AB |
Tomas Hansson |
| K161468 |
02/08/2017 |
Transformair Indoor Air Purifier |
Transformair, LLC |
Jaya Rao |
| K172405 |
12/11/2017 |
SNIPER STAPLE SYSTEM, NON-STERILE |
Trilliant Surgical |
Jon Olson |
| K163095 |
02/01/2017 |
Lyme B. burgdorferi (IgG) MarStripe Test |
Trinity Biotech |
Kevin Lawson |
| K172257 |
12/22/2017 |
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) |
True Diagnostics, Inc |
Jerry Lee |
| K172185 |
12/21/2017 |
Tyber Medical PT Interbody Spacer System |
Tyber Medical LLC |
Mark F. Schenk |
| K163322 |
02/23/2017 |
TZ SKULL PIN Adult |
TZ MEDICAL INC |
JOHN LUBISICH |
| K160835 |
02/02/2017 |
Titan 3W |
TZORA ACTIVE SYSTEMS LTD. |
Adi Shemer |
| K173524 |
12/13/2017 |
ANAX 5.5Ö Spinal System |
U&I Corporation |
Jee Ae Bang |
| K172419 |
12/04/2017 |
VelofixÖ TLIF Cage |
U&i Corporation |
Jee-Ae Bang |
| K160934 |
02/06/2017 |
UC-CARE NaviGo Workstation |
UC-CARE LTD. |
TOMER SCHATZBERGER |
| K170279 |
12/12/2017 |
Disposable High Pressure Syringe |
Union Medical Shenzhen Co., Ltd. |
Wenguo Zhang |
| K161360 |
02/01/2017 |
U2 Total Knee System, PSA Tibial Insert |
UNITED ORTHOPEDIC CORPORATION |
KAREN HO |
| K163607 |
12/15/2017 |
ECG Acquisition Systems |
VALES & HILLS BIOMEDICAL TECH. LTD. |
Jianfang Liu |
| K162018 |
02/28/2017 |
Surface Applicator Set |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K173266 |
12/01/2017 |
Octane aspiration system |
Vascular Solutions Inc. |
Becky Astrup |
| K173532 |
12/15/2017 |
Raider Guidewire |
Vascular Solutions, Inc. |
Beka Vite |
| K161901 |
02/03/2017 |
TrapLiner catheter |
Vascular Solutions, Inc. |
Beka Vite |
| K162467 |
02/01/2017 |
Twin-Pass Torque |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
| K163508 |
02/09/2017 |
PIVO |
Velano Vascular |
Tiffini Diage |
| K170950 |
12/20/2017 |
Well-Root ST |
Vericom Co., Ltd. |
Hyoshin Chung |
| K170218 |
02/24/2017 |
Vesco Medical NRFit Tip Syringes |
Vesco Medical, LLC |
Chris O'Keefe |
| K163703 |
02/08/2017 |
VIVIX-S 1417N |
VIEWORKS CO., LTD. |
JORDIN KIM |
| K162393 |
02/24/2017 |
The ViewRay (MRIdian) Linac System |
VIEWRAY INCORPORATED |
SEAN DELANEY |
| K163487 |
02/13/2017 |
Ultima HA Coated Half Pins and Wire |
Vilex in Tennessee, Inc |
Sylvia Southard |
| K171447 |
12/05/2017 |
OxyPure Color Silicone Hydrogel Soft Contact Lenses |
Visco Vision Inc |
Evan Huang |
| K171553 |
12/08/2017 |
W&H Assistina Twin |
W & H Dentalwerk Buermoos GmbH |
Mag. Anja Lindner |
| K163217 |
02/10/2017 |
GORE BIO-A Tissue Reinforcement |
W. L. GORE & ASSOCIATES, INC. |
Barbara L Smith |
| K162926 |
02/23/2017 |
Air-Powered Handpieces and Handpiece Attachments |
W&H DENTALWERK BURMOOS GMBH |
Anja Lindner |
| K163051 |
02/21/2017 |
ClearLumen II Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K163037 |
02/17/2017 |
Intra medullary endo-transilluminating device (iMET device) |
WEMED BIO-TECH INC. |
YIN-JIUN TSENG |
| K163511 |
02/02/2017 |
NovaGuard SA Pro Safety System |
WEST PHARMACEUTICAL SERVICES, INC. |
Ana Ladino |
| K170797 |
12/06/2017 |
wettrust D2care |
Wettrust Korea Co., Ltd. |
Sungho Lee |
| K172578 |
12/07/2017 |
Equipment Pouch |
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K171611 |
12/15/2017 |
Double Lumen Ovum Aspiration Needles |
William A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K170257 |
02/24/2017 |
Sydney IVF Culture Oil |
William A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K171513 |
12/07/2017 |
Lunderquist Extra Stiff Wire Guide |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K171573 |
12/29/2017 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K173013 |
12/14/2017 |
WishBone K-Wire System |
WishBone Medical, Inc. |
Gary Barnett |
| K170265 |
02/23/2017 |
GRAVITYTM PEEK-OPTIMA Suture Anchor |
Wright Medical Technology, Inc. |
Tara Conrad |
| K162795 |
02/22/2017 |
PROPHECY INVISION Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K172706 |
12/22/2017 |
GammaPod - Model A |
Xcision Medical Systems, LLC |
Daniel R. Plonski |
| K161907 |
02/23/2017 |
Pressure Therapy System |
XIAMEN SENYANG CO., LTD. |
XINJIE SHAO |
| K161859 |
02/24/2017 |
MagnetOs |
XPAND BIOTECHNOLOGY BV |
YVONNE P. BOVELL |
| K162824 |
02/17/2017 |
Z-Span Plate System |
Zavation, LLC |
Frankie Cummins |
| K161484 |
02/24/2017 |
ZIIP Device |
ZIIP,LLC |
David Mason |
| K163543 |
02/28/2017 |
Biomet Fusion System |
Zimmer Biomet Spine Inc. |
Megan Fessenden |
| K170072 |
02/07/2017 |
Fitmore« Hip Stem |
Zimmer GmbH |
Thomas Lincoln |
| K171858 |
12/18/2017 |
Sidus Stem-Free Shoulder |
Zimmer GmbH |
Roberto Tommasini |
