| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K160127 |
01/20/2016 |
iCodeConnect |
3B MEDICAL, INC. |
ALEX LUCIO |
| K163207 |
11/15/2016 |
Filtek One Bulk Fill Restorative |
3M Company |
Scott Erickson |
| K163342 |
11/29/2016 |
i-STAT Hematocrit test with i-STAT Alinity System |
Abbott Laboratories |
Tamara McCaw |
| K163271 |
11/21/2016 |
i-Stat Alinity System with i-Stat Glucose test |
Abbott Point of Care, Inc. |
Maria L Figueroa |
| K163092 |
11/04/2016 |
TubeClear Control Box and Clearing Stem |
Actuated Medical, Inc. |
Thomas L. Cronin |
| K163254 |
11/21/2016 |
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A Bonafini |
| K163355 |
11/30/2016 |
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K160203 |
01/28/2016 |
ADAMANT ZIRCONIA DISC |
Adamant Co., Ltd. |
Deborah Lavoie Grayeski |
| K163050 |
11/01/2016 |
Advance Medical Designs, Inc. Sterile Ultrasound Gel |
ADVANCE MEDICAL DESIGNS, INC. |
DAVID MACKIE |
| K163062 |
11/02/2016 |
PHMB Antimicrobial Foam Wound Dressing |
Advanced Medical Solutions Ltd. |
Kay McGrath |
| K160171 |
01/27/2016 |
Illuminated Mediastinal Access Port |
Aegis Surgical Ltd |
William Starling |
| K163228 |
11/17/2016 |
APVolution System |
AESTHETIC-PRESS, LLC |
Jorg Muller |
| K163274 |
11/21/2016 |
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument |
Aggredyne, Inc. |
Philip C. Speros |
| K163367 |
11/30/2016 |
GenetiSure Dx Postnatal Assay |
Agilent Technologies, Inc. |
Lois Nakayama |
| K160221 |
01/29/2016 |
Implance Dental Implant System, Implance Dental Abutment System |
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. |
Gorkem Serce |
| K163057 |
11/01/2016 |
Relizorb |
Alcresta Therapeutics, Inc. |
Robert Gallotto |
| K163266 |
11/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| K160123 |
01/20/2016 |
Apinator |
Allen J. Moses, DDS LTD |
Allen J Moses |
| K163192 |
11/15/2016 |
Comfort EC710 |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
| K160075 |
01/14/2016 |
Accent XL |
Alma Lasers Inc. |
Avi Farbstein |
| K163061 |
11/01/2016 |
Altus Spine Cervical Plate System |
Altus Partners, LLC |
Claudia Hill |
| K163238 |
11/18/2016 |
Eclipse Kiss Zirconia |
AMS |
HYUNA KIM |
| K160014 |
01/04/2016 |
iHealth Track Blood Pressure Monitor |
Andon Health Co., Ltd |
Liu Yi |
| K163276 |
11/21/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
LIU YI |
| K163141 |
11/09/2016 |
NAMIC ClearaCIL Contrast Injection Lines |
AngioDynamics, Inc. |
Teri Juckett |
| K163356 |
11/30/2016 |
Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter |
ANGIODYNAMICS, INC. |
ROBIN FULLER |
| K163107 |
11/07/2016 |
Lifestyles Zero Lubricated Latex Male Condom |
ANSELL HEALTHCARE PRODUCTS, LLC |
Robert Mahler |
| K163049 |
11/01/2016 |
GOLNIT Non-Absorbable PTFE Surgical Suture |
Antarma dba Golnit Sutures |
Armine Badalyan |
| K163359 |
11/30/2016 |
ARK Methotrexate Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K160062 |
01/12/2016 |
AUTION ELEVEN Semi-Automated Urinalysis System |
ARKRAY, Inc. |
Tom Speikers (U.S. Agent) |
| K160018 |
01/05/2016 |
Arrow Quickflash Arterial Catheterization Device |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
TRACY LARISH |
| K163253 |
11/18/2016 |
Arterys Cardio DL |
ARTERYS INC. |
Golnaz Moeini |
| K163142 |
11/09/2016 |
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader |
ArthroCare Corporation |
Laura Kasperowicz |
| K160185 |
01/27/2016 |
Wrist 3 |
ASPECT IMAGING LTD |
ISRAEL CITRON |
| K160154 |
01/20/2016 |
ALTA Anterior Cervical Interbody Spacer |
Astura Medical |
Troy Taylor |
| DEN160003 |
01/19/2016 |
Quantidex qPCR BCR-ABL IS Kit |
ASURAGEN, INC. |
FAYYAZ MEMON |
| K163261 |
11/21/2016 |
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip |
ATRICURE INC. |
Jonathan McElwee |
| K163231 |
11/17/2016 |
Chameleon PTA Balloon Catheter |
AV Medical Technologies Ltd |
Limor Sandach |
| K163264 |
11/21/2016 |
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled |
Avinger, Inc. |
Patty Hevey |
| K163358 |
11/30/2016 |
Introcan Safety 3 Closed IV Catheter |
B.BRAUN MELSUNGEN AG |
ULRICH JEDELHAUSER |
| K163245 |
11/18/2016 |
Virtual Occupational Therapy Application (VOTA) |
Barron Associates, Inc. |
Bruce G. Wilson |
| K160007 |
01/04/2016 |
Paclitaxel Sets |
BAXTER HEALTHCARE CORPORATION |
Tiffany Lin |
| K160161 |
01/27/2016 |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
Becton, Dickinson & Co. |
Gregory P. Payne |
| K160164 |
01/27/2016 |
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit |
Becton, Dickinson & Co. |
Gregory P. Payne |
| K163123 |
11/08/2016 |
Q-Switched Nd:YAG Laser Therapy Systems |
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
HUAN KONG |
| K160112 |
01/19/2016 |
Besmed PEEP Valve |
BESMED HEALTH BUSINESS CORP. |
ERIC LI |
| K160068 |
01/13/2016 |
FilmArray Respiratory Panel (RP) for use with FilmArray Torch |
BioFire Diagnostics, LLC |
KRISTEN J. KANACK |
| K160101 |
01/19/2016 |
SinuBand |
BIOINSPIRE TECHNOLOGIES, INCORPORATED |
DORNA HAKIMIMEHR |
| K163128 |
11/08/2016 |
Epic Pro |
Biolase, Inc |
Alicia Mszyca |
| K163083 |
11/03/2016 |
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) |
bioMerieux, Inc. |
Mary Beth Anheuser |
| K160058 |
01/12/2016 |
Biomet Variable Pitch Compression Screw System |
Biomet Inc |
Julie Largent |
| K160071 |
01/13/2016 |
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis |
Biomet, Inc. |
Carmen Albany |
| K163171 |
11/14/2016 |
CeraClean |
Bisco, Inc. |
Ryan Hobson |
| K160227 |
01/29/2016 |
ACCENTO / HWA Dual/Single laser |
BISON MEDICAL CO LTD |
SUN WOO LEE |
| K163126 |
11/08/2016 |
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) |
Blue Sail Medical Co., Ltd |
Robin Liu |
| K163251 |
11/18/2016 |
Life Essence Universal Porcelain System |
BLUE SKY BIO |
ALBERT ZICKMANN |
| K160204 |
01/28/2016 |
BSD4343 Digital Flat Panel X-ray Detector |
BONTECH INC. |
Kwang S. Choi |
| K163058 |
11/01/2016 |
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle |
BOSTON SCIENTIFIC |
Jennifer Edouard |
| K163272 |
11/21/2016 |
AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Kayla Mackey |
| K163174 |
11/14/2016 |
Emerge PTCA Dilatation Catheter |
Boston Scientific Corporation |
Jane Horan |
| K163248 |
11/18/2016 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
Boston Scientific Corporation |
Yingying Gao |
| K163314 |
11/23/2016 |
Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter |
Boston Scientific Corporation |
Nikki Wahlberg |
| K163200 |
11/15/2016 |
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete |
BOSTON SCIENTIFIC CORPORATION |
Ka Zoua Xiong |
| K160173 |
01/27/2016 |
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) |
Boston Scientific Corporation |
Eric Elliott |
| K163267 |
11/21/2016 |
NITRILE EXAMINATION GLOVE |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K163165 |
11/10/2016 |
AM-100 |
BTL INDUSTRIES, INC |
David Chmel |
| K163176 |
11/14/2016 |
Exilis XP II |
BTL Industries, Inc. |
David Chmel |
| K163216 |
11/16/2016 |
Pinpoint GT Needles |
C.R. Bard, Inc. |
Silvia De La Barra |
| K163170 |
11/14/2016 |
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 |
CAPILLUS, LLC |
PATRICIA SCHNOOR |
| K160020 |
01/05/2016 |
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System |
Captiva Spine |
Tamala J. Wampler |
| K160002 |
01/04/2016 |
Piccolo Composite(R) Distal Volar Radius Plate System |
CARBOFIX ORTHOPEDICS LTD. |
Yael Rubin |
| K163316 |
11/23/2016 |
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System |
CAREFUSION 303, INC. |
Erika Fernandez |
| K163157 |
11/10/2016 |
SmartGrid |
Carestream Health |
Diane Koetter |
| K163203 |
11/15/2016 |
Carestream DRX-Evolution |
Carestream Health, Inc. |
Carolyn L. Wagner |
| K163255 |
11/21/2016 |
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor |
Caretaker Medical, LLC |
Jeff Pompeo |
| K163195 |
11/15/2016 |
PRIMUS |
Carl Zeiss Suzhou Co., Ltd. |
Huang XiaoDong |
| K160081 |
01/15/2016 |
TENS Electrodes |
CATHAY MANUFACTURING CORP. |
Ren Ren |
| K163090 |
11/04/2016 |
Plasma Edge System |
Chirurgie Innovation |
Guillaume Noury |
| K163323 |
11/25/2016 |
Dolphix« External Fixation System MR Conditional |
CITIEFFE s.r.l |
Stefano Pullega |
| K163313 |
11/23/2016 |
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
Kevin Mader |
| K163138 |
11/09/2016 |
Clarius Ultrasound System |
Clarius Mobile Health Corp. |
Abhijit Ahir |
| K163139 |
11/09/2016 |
PleuraFlow System with FlowGlide |
CLEARFLOW, INC. |
DOV GAL |
| K163214 |
11/16/2016 |
Unicare System, Unicare Manipulator |
ClearPath Surgical, Inc. |
Puja Ohlhaver |
| K163103 |
11/07/2016 |
Tranberg CLS Diffusor Laser Fiber |
Clinical Laserthermia Systems AB |
Lars-Erik Eriksson |
| K160181 |
01/27/2016 |
COLORADO THERAPEUTICS XENOGRAFT IMPLANT |
Colorado Therapeutics LLC |
WILLIAM JACKSON |
| K160025 |
01/06/2016 |
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System |
CONFORMIS, INC. |
Amita Shah |
| K163258 |
11/21/2016 |
CrossFT Knotless Suture Anchor with Disposable Driver |
ConMed Corporation |
Nyrobia Freeman |
| K163167 |
11/14/2016 |
CKS Plus Knee System |
CONSENSUS ORTHOPEDICS, INC. |
ZAC JOHNSON |
| K160136 |
01/20/2016 |
Flowable Wound Matrix |
COOK BIOTECH INCORPORATED |
PERRY W. GUINN |
| K163197 |
11/15/2016 |
Cook Holmium Laser Fiber |
COOK INCORPORATED |
Colin Jacob |
| K160219 |
01/29/2016 |
Hilal Embolization MicroCoils |
Cook Incorporated |
David Lehr |
| K160200 |
01/28/2016 |
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set |
COOK INCORPORATED |
Kotei Aoki |
| K163353 |
11/30/2016 |
Needle's Eye Snare Retrieval Set - 54cm |
Cook Incorporated |
Thomas Kardos |
| K163318 |
11/23/2016 |
Soules Intrauterine Insemination Catheter |
Cook Incorporated |
Naomi N. Funkhouser |
| K160217 |
01/29/2016 |
uVue HSG/SHG Catheter |
COOK INCORPORATED |
Kara Kanorr |
| K160223 |
01/29/2016 |
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter |
COOK INCORPORATED |
STEVEN LAWRIE |
| K163169 |
11/14/2016 |
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent |
COOK IRELAND LTD |
Charlene Ryan |
| K163104 |
11/07/2016 |
TerraceÖ Anterior Cervical Plate System |
CoreLink, LLC |
Stephan Jones |
| K160157 |
01/22/2016 |
LOSPA Modular Knee System |
CORENTEC CO., LTD |
Goon Hee Lee |
| K160121 |
01/19/2016 |
CorPath GRX System |
Corindus, Inc. |
Michael Douglas |
| K163102 |
11/07/2016 |
ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm |
COVIDIEN |
KATIE BROWN |
| K163055 |
11/01/2016 |
Reprocessed Kendall SCD Express Foot Cuff |
COVIDIEN |
Jennifer Sullivan |
| K160176 |
01/27/2016 |
Signia Stapler |
Covidien |
Frank Gianelli |
| K163105 |
11/07/2016 |
Emprint Ablation System |
COVIDIEN LLC |
PATTI ARNDT |
| K163098 |
11/07/2016 |
Tri-Staple 2.0 Intelligent Cartridge |
Covidien LLC |
REBECCA BREWER |
| K160118 |
01/19/2016 |
STROPP (Single Tunnel Repair of Plantar Plate) |
CROSSROADS EXTREMITY SYSTEMS, LLC |
Vernon Hartdegen |
| K163244 |
11/18/2016 |
truFreeze System |
CSA MEDICAL, INC. |
Sherrie Coval-Goldsmith |
| K160088 |
01/15/2016 |
Cydar EV |
Cydar Ltd. |
John Clarke |
| K163067 |
11/02/2016 |
CyMedica e-viveÖ System; CY-1000 |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K160180 |
01/27/2016 |
Intermittent Pneumatic Compression system |
DaeSung Maref Co., Ltd |
Jae-wha Lee |
| K160178 |
01/27/2016 |
Lympha-Flow(LF1200) |
DaeSung Maref Co., Ltd |
Jae-wha Lee |
| K160005 |
01/04/2016 |
Contact Lens Case (multiple brand name) |
DANYANG CHANXIN GLASSES CASES FACTORY |
LEMON CHEN |
| K160166 |
01/27/2016 |
X-MIND trium |
DE GOTZEN S.R.L. |
Olivier Balouka |
| K160213 |
01/29/2016 |
s-Clean Tapered II RBM Implant System |
Dentis Co., Ltd. |
Sun Chul Shin |
| K160207 |
01/28/2016 |
ATLANTIS ISUS Implant Suprastructures |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K163155 |
11/10/2016 |
MTM Clear Aligner |
DENTSPLY SIRONA |
HELEN LEWIS |
| K163350 |
11/30/2016 |
Multibase Abutments EV and ATLANTIS Suprastructures |
DENTSPLY SIRONA |
KARL NITTINGER |
| K163046 |
11/01/2016 |
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long |
DEPUY SYNTHES |
JOANNA RIEDER |
| K163137 |
11/09/2016 |
NIRA Beauty Skin Laser |
Dermal Photonics Corporation |
David Bean |
| K160199 |
01/28/2016 |
Advocate Insulin Pen Needles |
Diabetic Supply of Suncoast, Inc. |
Victoria Thuss |
| K160060 |
01/12/2016 |
DMi Dental Implant System |
DMi Innovative Medical Technology Ltd. |
Yaniv Haim Buchacho |
| K163150 |
11/09/2016 |
ViMove2 |
DORSAVI LTD |
DAN RONCHI |
| K163166 |
11/14/2016 |
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only |
EASYWELL BIOMEDICALS, INC. |
ARTHUR CHEN |
| K160084 |
01/15/2016 |
Swan Ganz Catheters |
Edwards Lifesciences, LLC |
Mugdha Dongre |
| K163335 |
11/28/2016 |
6MP Color LCD Monitor, RadiForce RX660, RX660-AR |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K160041 |
01/08/2016 |
Cobbra RF Tissue Dissector |
ELLIQUENCE LLC. |
PAUL D. BUHRKE |
| K163071 |
11/02/2016 |
vascuCAP |
Elucid Bioimaging, Inc. |
Andrew J. Buckler |
| K163226 |
11/17/2016 |
EPIC Extremely Small Staple |
Epic Extremely, LLC |
Dan Schwartzbauer |
| K163082 |
11/03/2016 |
6200 Ultrasound System and 6250 Ultrasound System |
ESAOTE S.P.A |
MASSIMO POLIGNANO |
| K160128 |
01/20/2016 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
Marjorie Medina |
| K163152 |
11/10/2016 |
PROLENE Soft Polypropylene Mesh |
Ethicon, Inc. |
Debbie Fazen |
| K163065 |
11/02/2016 |
T3 Software |
ETIOMETRY, INC. |
DIMITAR BARONOV |
| K160191 |
01/27/2016 |
Align Anterior Ankle Fusion Plate |
Extremity Medical, LLC |
Brian Smekal |
| K163209 |
11/15/2016 |
Fiagon Navigation System |
FIAGON GMBH |
Dirk Mucha |
| K163125 |
11/08/2016 |
gekoÖ T-2 and gekoÖ Plus R-2 Neuromuscular Stimulators |
FIRSTKIND LIMITED |
NEIL BUCKLEY |
| K163300 |
11/22/2016 |
ThermoShield HME Filter |
Flexicare Medical Limited |
Joel Biddle |
| K163085 |
11/03/2016 |
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack |
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC |
Irene M. Guzman |
| K160195 |
01/27/2016 |
Forma System, Forma Light System |
FORMATK SYSTEMS LTD. |
AMIT GOREN |
| K163148 |
11/09/2016 |
BePOD« Foot Screws |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K160139 |
01/21/2016 |
Luggie Chair |
FREERIDER CORPORATION |
Arthur Wang |
| K160196 |
01/27/2016 |
Fujifilm Video Colonoscope Model EC-600WL V2 |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha More |
| K160108 |
01/19/2016 |
Synapse PACS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Jyh-Shyan Lin |
| K163053 |
11/01/2016 |
Lumipulse G E2-III Calibrators |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K160090 |
01/15/2016 |
Lumipulse G ROMA |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K160116 |
01/19/2016 |
SpiroScout |
GANSHORN MEDIZIN ELECTRONIC GMBH |
Stefan Ponto |
| K160131 |
01/20/2016 |
OEC Elite MiniView |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
LIFENG WANG |
| K160182 |
01/27/2016 |
LOGIQ S7 Expert |
GE Healthcare |
Bryan Behn |
| K163302 |
11/22/2016 |
Senographe Pristina |
GE Healthcare |
Camille Vidal |
| K160162 |
01/27/2016 |
Voluson P6, Voluson P8 |
GE HEALTHCARE |
Tracey Ortiz |
| K160184 |
01/27/2016 |
Voluson S6, Voluson S8, Voluson S10 |
GE HEALTHCARE |
TRACEY ORTIZ |
| K163205 |
11/15/2016 |
48CH Head Coil |
GE Healthcare Coils (USA Instruments, Inc.) |
Mary A. Mayka |
| K163077 |
11/03/2016 |
LOGIQ E9, LOGIQ E9 XDClear 2.0 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K160078 |
01/14/2016 |
Vivid T8 |
GE Medical Systems Ultrasound and Primary Care Diagnotics, L |
Tracey Ortiz |
| K163213 |
11/16/2016 |
Revolution CT |
GE Medical Systems, L.L.C. |
Helen Peng |
| K163331 |
11/28/2016 |
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist |
GE Medical Systems, LLC |
Mary A. Mayka |
| K163281 |
11/21/2016 |
FastStroke |
GEf Medical Systems SCS |
Kristine Schraufnagel |
| K160065 |
01/13/2016 |
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System |
GEMSS MEDICAL SYSTEMS CO., LTD |
Sang Woo Lee |
| K163140 |
11/09/2016 |
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System |
GEMSS MEDICAL SYSTEMS CO., LTD |
Sang Woo Lee |
| DEN160001 |
01/11/2016 |
BD MAX Vaginal Panel, BD MAX Instrument |
GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) |
MANON RICHARD |
| K160079 |
01/14/2016 |
rainbow Shine |
GENOSS Co. Ltd. |
Byungsun Kim |
| K160144 |
01/21/2016 |
rainbow LS Block |
GENOSS CO., LTD. |
HAN YEIN |
| K163144 |
11/09/2016 |
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) |
GKE-GMBH |
Ulrich Kaiser |
| K163361 |
11/30/2016 |
ANTHEMÖ Fracture System |
Globus Medical Inc. |
Kelly J. Baker |
| K160138 |
01/21/2016 |
Adhesive Electrodes |
GMDASZ MANUFACTURING CO., LTD |
CHARLES MACK |
| K163096 |
11/04/2016 |
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System |
GPC MEDICAL LIMITED |
VIKAS NARANG |
| K163113 |
11/07/2016 |
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K163191 |
11/14/2016 |
ComfortGuard Surgical Gown, i600, Film Reinforced |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
Martin D. Paugh |
| K160197 |
01/27/2016 |
Haemonetics Cell Saver Elite Autotransfusion System |
Haemonetics Corporation |
Mark Anzalone |
| K160132 |
01/20/2016 |
Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC |
HAGER & MEISINGER GMBH |
Melanie May |
| K163236 |
11/17/2016 |
COOLIEF Cooled Radiofrequency Kit |
Halyard Health, Inc. |
Mary Ann B Kinard |
| K163283 |
11/21/2016 |
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 |
HAMILTON MEDICAL AG |
Steffen Boden |
| K160102 |
01/19/2016 |
Amber Mill Series and Amber Press Series |
HASS CORP. |
YONGSU KIM |
| K160140 |
01/21/2016 |
DENTRIa series |
HDX WILL CORP. |
Hyung-suk Oh |
| K160145 |
01/21/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
Health & Life Co., Ltd. |
Sarah Su |
| K163079 |
11/03/2016 |
HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System |
HealthLight, LLC |
Warren Graber |
| K163146 |
11/09/2016 |
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
Shaozhang Nan |
| K163168 |
11/14/2016 |
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) |
HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED |
Liu Wei |
| K160049 |
01/11/2016 |
Charisma |
Heraeus Kulzer, LLC (Mitsui Chemicals Group) |
Jamie Cleveland |
| K160152 |
01/22/2016 |
Trillium Oval V 5.1 MRI System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Douglas Thistlethwaite |
| K163179 |
11/14/2016 |
Onli Intermittent Catheter |
HOLLISTER INCORPORATED |
JEANNE LEE |
| K163052 |
11/01/2016 |
Brevera Biopsy System with Corlumina Imaging Technology |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K160022 |
01/05/2016 |
LUOFUCON Silicone Ag foam dressing |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
Guosheng Tan |
| K160160 |
01/27/2016 |
Non-Telescopic PenEvac |
I.C. Medical, Inc. |
Elena S. Buiga |
| K163343 |
11/29/2016 |
Icare HOME tonometer |
Icare Finland Oy |
Matti Tulikoura |
| K160023 |
01/06/2016 |
Electronic Stethoscope DS301 |
IMEDIPLUS INC. |
SHIRLEY LAI |
| K163133 |
11/08/2016 |
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K163177 |
11/14/2016 |
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K163260 |
11/21/2016 |
SeptiCyte LAB |
IMMUNEXPRESS, INC. |
VICTORIA ROTHWELL |
| K163225 |
11/17/2016 |
AFIAS iFOB with AFIAS-50 |
IMMUNOSTICS, INC. |
Antoinette Prusik |
| K160226 |
01/29/2016 |
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector |
Implanet, S.A. |
Regis Le Couedic |
| K163127 |
11/08/2016 |
bellavista 1000 |
IMTMEDICAL AG |
BEAT KELLER |
| K160174 |
01/27/2016 |
I.B.S. 2.0 Osteosynthesis screw |
In2Bones SAS |
Morgane Grenier |
| K163293 |
11/22/2016 |
ColinkÖ Plating System |
IN2BONESUSA, LLC |
JOE CLIFT |
| K163290 |
11/22/2016 |
INFINITT ULite |
INFINITT CO., LTD. |
Heejin Lim |
| K160064 |
01/13/2016 |
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System |
INFOBIONIC, INC. |
NANCY BRIEFS |
| K163345 |
11/29/2016 |
TVC Imaging System, TVC Catheter |
Infraredx, Inc. |
Stephen Sum |
| K163190 |
11/14/2016 |
InMode RF System |
INMODE MD LTD. |
Amit Goren |
| K160225 |
01/29/2016 |
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 |
| K163326 |
11/28/2016 |
SmartEP |
INTELLIGENT HEARING SYSTEMS |
Edward Miskiel |
| K160216 |
01/29/2016 |
Revolution Spinal Fixation System |
INTELLIGENT IMPLANT SYSTEMS, LLC |
MICHAEL NUTT |
| K163056 |
11/01/2016 |
RevolutionÖ Spinal Fixation System |
Intelligent Implant Systems, LLC |
Michael Nutt |
| K163256 |
11/21/2016 |
Dual Mode Infrared Thermometer |
Intelliworks LLC |
Dr. Jessica Leonardi |
| K163149 |
11/09/2016 |
VisualEyes |
Interacoustics A/S |
Erik Nielsen |
| K160006 |
01/04/2016 |
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit |
Irvine Scientific |
Jayme Yamaguchi-Owens |
| K163270 |
11/21/2016 |
ISEN-Goggles with Data Viewer |
ISENT TECH & TRADING COMPANY,LTD. |
MARTIN LIU |
| K163185 |
11/14/2016 |
OptiLux LED Illuminator |
ISOLUX LLC |
NIKOLAOS ANDREOULAKIS |
| K163223 |
11/16/2016 |
ORCA (tm) - Operational Rescue Containment Apparatus |
ISOVAC PRODUCTS, LLC |
PETER M. JENKNER |
| K163087 |
11/03/2016 |
PixoTest Blood Glucose Monitoring System |
iXensor Company Ltd. |
JAMIE WU |
| K163224 |
11/16/2016 |
JAZZ SOLO Sensor |
Jazz Imaging LLC |
Todd C. Miller |
| K160077 |
01/14/2016 |
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set |
JBW7 Innovations, LLC |
Jason B Wynberg |
| K163308 |
11/23/2016 |
SMARTO |
JEIL MEDICAL CORPORATION |
JAEHAN PARK |
| K163094 |
11/04/2016 |
TinniLogic Mobile Tinnitus Management Device |
JIANGSU BETTERLIFE MEDICAL CO., LTD. |
HONGWEI XU |
| K163093 |
11/04/2016 |
Safety Blood Collection Set |
Jiangsu Shenli Medical Production Co., Ltd |
Tina Cai |
| K163162 |
11/10/2016 |
Sterile Hypodermic Safety Syringes for Single Use |
JiangXi HongDa Medical Equipment Group Ltd. |
Yang Xiaohua |
| K163160 |
11/10/2016 |
Sterile Single-use Infusion Set |
JiangXi HongDa Medical Equipment Group Ltd. |
Xiaohua Yang |
| K163161 |
11/10/2016 |
Sterile Single-use Syringe with Needle |
JiangXi HongDa Medical Equipment Group Ltd. |
Yang Xiaohua |
| K163194 |
11/15/2016 |
Neodent Implant System - GM Line |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
Julianne Lechechem |
| K160212 |
01/29/2016 |
ACUVUE (senofilcon C) Soft Contact Lens |
Johnson & Johnson Vision Care, Inc. |
Ramona Haile |
| K160143 |
01/21/2016 |
ClearVision ExamVue Flat Panel Detector |
JPI HEALTHCARE, INC |
JANG WON LEE |
| K160125 |
01/20/2016 |
Cascadia Interbody System |
K2M |
Nancy Giezen |
| K163364 |
11/30/2016 |
MOJAVE Expandable Interbody System |
K2M |
Nancy Giezen |
| K160208 |
01/28/2016 |
NILE Alternative Fixation Spinal System |
K2M, Inc. |
NANCY GIEZEN |
| K163239 |
11/18/2016 |
SMARTmatic |
Kaltenbach & Voigt GmbH |
Stefan Trampler |
| K163317 |
11/23/2016 |
ELECTROmatic |
Kaltenbach & Voigt GmgH |
Stefan Trampler |
| K160013 |
01/04/2016 |
Crosperio OTW |
KANEKA CORPORATION |
TOSHIHIKO MOTOMINE |
| K160004 |
01/04/2016 |
Crosstella OTW |
KANEKA CORPORATION |
TOSHIHIKO MOTOMINE |
| K160044 |
01/08/2016 |
Image1 SPIES System |
KARL STORZ ENDOSCOPY AMERICA, INC. |
SUSIE S. CHEN |
| K163070 |
11/02/2016 |
Kent Camera |
KENT IMAGING INC. |
Darrell Barnhart |
| K163064 |
11/02/2016 |
Demi Ultra |
KERR CORPORATION |
Mohammad Saad Ansari |
| K160142 |
01/21/2016 |
MINERAL OIL |
KITAZATO BIOPHARMA CO., LTD. |
Futoshi INOUE |
| K163315 |
11/23/2016 |
Internal Distraction - Sterile |
KLS Martin LP |
Jennifer Damato |
| K163117 |
11/07/2016 |
Alpha Pure |
KOROAD AMERICA |
YEON JAE LEE |
| K163204 |
11/15/2016 |
A08 Power wheelchair |
Kunshan Aoshida Electric Technology Co., Ltd |
Shen Wenhua |
| K163352 |
11/30/2016 |
Wheelchair |
Kunshan Hi-Fortune Health Products Co.,Ltd. |
HongFa Zhi |
| K163201 |
11/15/2016 |
KYMCO EQ10D Scooter |
KWANG YANG MOTOR CO., LTD. |
Wang Ching Yun |
| K163159 |
11/10/2016 |
Dario Blood Glucose Monitoring System |
LabStyle Innovations, Ltd. |
Erez Raphael |
| K163247 |
11/18/2016 |
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider |
LAURIMED LLC |
Brian R DuBois |
| K163173 |
11/14/2016 |
Handheld Diode Laser for Hair Removal |
Liaoning Sidey Optoelectronics Technologies Co., Ltd. |
Li Zhao |
| K163334 |
11/28/2016 |
LiDCOunity v2 Hemodynamic Monitor |
LiDCO Ltd |
JI HEE KO |
| K160169 |
01/27/2016 |
The Life Spine Subtalar Implant System |
Life Spine |
Randy Lewis |
| K160066 |
01/13/2016 |
Pro-Link« Stand-Alone Cervical Spacer System |
Life Spine, Inc. |
Randy Lewis |
| K163153 |
11/10/2016 |
Livia |
LIFECARE LTD. |
AMNON NAHUM SHARON |
| K163357 |
11/30/2016 |
OneTouch Via On-Demand Insulin Delivery System |
LifeScan Europe, a division of Cilag GmbH |
Kirsten Franco |
| K160130 |
01/20/2016 |
BloodSTOP iX Battle Matrix |
LifeSciencePLUS Inc. |
Audrey Vitale |
| K160011 |
01/04/2016 |
H-Max S stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K163298 |
11/22/2016 |
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K163347 |
11/28/2016 |
xTAG Cystic Fibrosis 39 Kit v2 |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K163336 |
11/28/2016 |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR |
Luminex Molecular Diagnostics, Inc. |
Jennifer Grimes |
| K163196 |
11/15/2016 |
ACTION II Laser System |
LUTRONIC CORPORATION |
Jhung Won Vojir |
| K163282 |
11/21/2016 |
Apex Dental Sensors |
Masterlink LLC |
Tom Birney |
| K163156 |
11/10/2016 |
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides |
Materialise NV |
Oliver Clemens |
| K163221 |
11/16/2016 |
Mazor X |
Mazor Robotics Ltd. |
Ayelet Matia |
| K160063 |
01/13/2016 |
McLaren Proton Therapy System |
McLaren Health Care Corporation |
Ryan Vlcko |
| K160198 |
01/28/2016 |
UreTron MultiProbe Lithotripter System |
Med-Sonics Corp |
Jennifer Rautine |
| K163311 |
11/23/2016 |
GMK Revision Femoral Distal Augmentation |
Medacta International SA |
Stefano Baj |
| K163119 |
11/08/2016 |
NaviSuite SSI Edition |
MEDCOM GMBH |
JOHANNES MESSOW |
| K160117 |
01/19/2016 |
AbClose - Port Site Closure Device |
Medeon Biodesign, Inc |
GRETA CHANG |
| K160172 |
01/27/2016 |
Laparoscope Lens Shield Device |
Medeon Biodesign, Inc |
Greta Chang |
| K163091 |
11/04/2016 |
VibraPEP |
Medica Holdings, LLC |
George Reed |
| K163106 |
11/07/2016 |
CODMAN Integrated Bipolar Cord and Tubing Set |
Medos International SARL |
Megan Palumbo |
| K163158 |
11/10/2016 |
MEDSYNAPSE Zero Footprint Viewer |
MEDSYNAPTIC PRIVATE LTD. |
Ashish Dhawad |
| K163268 |
11/21/2016 |
FlexCath Select Steerable Shealth and Dilator |
Medtronic CryoCath LP |
Natalie Sadeghi |
| K163182 |
11/14/2016 |
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories |
Medtronic Powered Surgical Solutions |
Deep Pal |
| K163301 |
11/22/2016 |
CD HORIZON« Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Justin O'Connor |
| K163181 |
11/14/2016 |
TRANSLACEÖ Spinal Tethering System |
Medtronic Sofamor Danek USA, Inc. |
Becky Ronner |
| K163279 |
11/21/2016 |
Medtronic Transportation/Sterilization Cassettes |
Medtronic Sofamor Danek, USA, Inc. |
Julie Bassett |
| K160091 |
01/15/2016 |
Temperature Probe, Affinity Temperature Probe |
Medtronic, Inc. |
Choua Thao |
| K163076 |
11/03/2016 |
Segment CMR |
MEDVISO AB |
Einar Heiberg |
| K163280 |
11/21/2016 |
RP Lite 760R |
Mego Afek AC Ltd. |
Ilan Sharon |
| K163273 |
11/21/2016 |
TRU Legionella |
MERIDIAN BIOSCIENCE, INC. |
Lauren Davis |
| K160107 |
01/19/2016 |
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe |
Merit Medical Systems, Inc. |
Dan W Lindsay |
| K163084 |
11/03/2016 |
Merit Coronary Control Syringe |
Merit Medical Systems, Inc. |
Cory Marsh |
| K163101 |
11/07/2016 |
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set |
MICROGENICS CORPORATION |
MINOTI PATEL |
| K163154 |
11/10/2016 |
Traxcess 7 Mini XSoft Guidewire |
MicroVention, Inc. |
Sapna Singh |
| K163337 |
11/28/2016 |
Midmark and Ritter M9 and M11 UltraClave« Automatic Sterilizers and Ritter M9D AutoClave« Automatic Sterilizer |
Midmark Corporation |
ADAM CLUTTER |
| K160141 |
01/21/2016 |
miraDry System |
Miramar Labs, Inc. |
Kathy O'Shaughnessy |
| K160149 |
01/21/2016 |
Miret Grasper, Alligator, Miret Grasper, Maryland |
MIRET SURGICAL INC. |
AVI ROOP |
| K163349 |
11/29/2016 |
MIS V3 Conical Connection Dental Implant System¡ |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K163233 |
11/17/2016 |
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter |
MIVI NEUROSCIENCE, INC |
Randy LaBounty |
| K160126 |
01/20/2016 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging |
Norma J LeMay |
| K163249 |
11/18/2016 |
GoSpiro |
MONITORED THERAPEUTICS, INC. |
William Zimlich |
| K160015 |
01/04/2016 |
Pure Vu |
Motus GI Medical Technologies Ltd. |
Hagit Ephrath |
| K160129 |
01/20/2016 |
MRII Cranial Drill and Accessories |
MRI INTERVENTIONS, INC. |
PETER PIFERI |
| K163131 |
11/08/2016 |
A-dec NLZ Electric Motor System |
NAKANISHI, INC. |
KIMIHIKO SATOH |
| K163183 |
11/14/2016 |
Yooeehouse Breast Pump |
Nantong Poly Technology Co., Ltd. |
Rongmin Lin |
| K160209 |
01/28/2016 |
Gold Anchor |
NASLUND MEDICAL AB |
Tomas Naslund |
| K163163 |
11/10/2016 |
XLTEK EMU40EX EEG Headbox |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K163118 |
11/08/2016 |
FLEX Microwave Ablation System and Accessories |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
| K163188 |
11/14/2016 |
Next Science Wound Gel (Rx) |
Next Science, LLC |
Matthew Myntti |
| K163136 |
11/08/2016 |
Youha electric breast pump |
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. |
Huang Yun Jun |
| K163122 |
11/08/2016 |
NobelClinician, DTX Studio implant |
NOBEL BIOCARE AB |
CHALEMAGNE CHUA |
| K160158 |
01/27/2016 |
NobelProcera HT ML FCZ Implant Bridge and Framework |
Nobel Biocare AB |
Charlemagne Chua |
| K160119 |
01/19/2016 |
NobelSpeedy Groovy |
NOBEL BIOCARE AB |
Charlemagne Chua |
| K163324 |
11/25/2016 |
nordicBrainEx |
NordicNeurolab AS |
CHANDANA GURUNG BHANDARI |
| K160156 |
01/22/2016 |
StatStrip Xpress Blood Glucose Monitoring System |
NOVA BIOMEDICAL CORPORATION |
Eliza Wang |
| K163310 |
11/23/2016 |
NovaBone IRM |
NovaBone Products, LLC |
Gregory Pomrink |
| K163230 |
11/17/2016 |
NuVasive Modulus XLIF Interbody System |
NUVASIVE INCORPORATED |
Cynthia Adams |
| K160051 |
01/11/2016 |
NuVasive« Interfixated Interbody System |
NuVasive, Incorporated |
Michelle Cheung |
| K160038 |
01/07/2016 |
UniStrip1 Generic Blood Glucose Test Strips |
OK BIOTECH CO., LTD. |
KE-MIN JEN |
| K163069 |
11/02/2016 |
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K160098 |
01/19/2016 |
Single Use Aspiration Needle NA-U401SX |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K160053 |
01/11/2016 |
Monopolar single-use HF cable |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K163332 |
11/28/2016 |
Apex Revision Knee System |
OMNIlife science |
Christina Rovaldi |
| K163338 |
11/28/2016 |
OMNIBotics Knee System |
OMNllife Science Inc. |
Daniel Decruppe |
| K160115 |
01/19/2016 |
Heat Pain Pro |
OMRON HEALTHCARE, INC. |
RENEE Thornborough |
| K163235 |
11/17/2016 |
HEM-9210T |
Omron Healthcare, Inc. |
Renee Thornborough |
| K163180 |
11/14/2016 |
Hubble II |
Orbbo Surgical, LLC |
Eric Garofano |
| K163265 |
11/21/2016 |
Kepler II |
Orbbo Surgical, LLC |
Eric Garofano |
| K163114 |
11/07/2016 |
Sapphire II PRO |
OrbusNeich Medical Inc. |
John Pazienza |
| K163048 |
11/01/2016 |
Smart Stitching Software System, Image Processing, Radiological |
OSKO, INC. |
Richard Jeon |
| K163054 |
11/01/2016 |
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K163088 |
11/04/2016 |
TSIII BA Fixture |
OSSTEM IMPLANT Co., Ltd. |
Hee Kwon |
| K163303 |
11/22/2016 |
OsteoMed ExtremiFix Mid and Large Screw System |
OsteoMed LLC |
Ellen Hong |
| K160076 |
01/14/2016 |
XCageÖ Interbody Fusion System |
Ouroboros Medical, Inc. |
John To |
| K163109 |
11/07/2016 |
OxyHeal 4000 Multiplace Hyperbaric Chamber Family |
OXYHEAL MEDICAL SYSTEMS, INC. |
EDWARD J. CHOMAS |
| K160194 |
01/27/2016 |
StarFuse Interphalangeal Pin |
Phalanx Innovations |
Daniel Lanois |
| K163210 |
11/15/2016 |
Philips CombiDiagnost R90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K163116 |
11/07/2016 |
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 |
Philips Medical Systems Nederland B.V. |
Ruojuan Zhang |
| K163250 |
11/18/2016 |
Longitudinal Brain Imaging (LoBI) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K160147 |
01/21/2016 |
CT TrueView |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
JEANETTE BECKER |
| K163120 |
11/08/2016 |
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Peng Cui |
| K163328 |
11/28/2016 |
Planmed Clarity |
Planmed Oy |
Lars Moring |
| K163327 |
11/28/2016 |
Precifit Medical Kirschner Wires |
PRECIFIT MEDICAL LTD |
ZHEN YU(ERIC) WU |
| K160012 |
01/04/2016 |
O-pel Laser and families of probe delivery devices |
PRECISE LIGHT SURGICAL |
KEN ARNOLD |
| K160100 |
01/19/2016 |
Prestige Ameritech Pediatric/ChildÆs Face mask |
Prestige Ameritech |
RODNEY GREGORY |
| K163329 |
11/28/2016 |
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 |
PULSADERM LLC |
Gloria Avendano |
| K160082 |
01/15/2016 |
Puritan Opti-Tranz Cary-Blair Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K163068 |
11/02/2016 |
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent |
Q UROLOGICAL CORPORATION |
SCOTT EPSTEIN |
| K163066 |
11/02/2016 |
TxRx Knee 15 Flare MR Coil 3.0T |
QUALITY ELECTRODYNAMICS, LLC |
Kathleen Aras |
| K163222 |
11/16/2016 |
Discovery Pico Family |
Quanta System Spa |
Francesco Dell'Antonio |
| K160153 |
01/22/2016 |
ABL90 FLEX PLUS |
RADIOMETER MEDICAL APS |
SOEREN BOEGESTRAND |
| K163295 |
11/22/2016 |
Infant Transport Mattress Warmer with Disc |
RAPID AID CORP. |
Laureta Prifti |
| K160093 |
01/19/2016 |
RayStation |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K160067 |
01/13/2016 |
RenovoCath |
RenovoRx, Inc. |
Kamran Najmabadi |
| K163277 |
11/21/2016 |
SuperNO2VA Device |
Revolutionary Medical Devices, Inc. |
David M. Kane |
| K160192 |
01/27/2016 |
Atteris Antimicrobial Skin & Wound Cleanser |
ROCHAL INDUSTRIES LLC |
WILLIAM J. COULSTON |
| K163184 |
11/14/2016 |
cobas« CT/NG v2.0 Test |
Roche Molecular Systems, Inc. |
David W. Gates |
| K163321 |
11/25/2016 |
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
ROCKET MEDICAL PLC |
Tracy Charlton |
| K163206 |
11/15/2016 |
SMD-Sr90-DA Radionuclide Brachytherapy Source |
Salutaris Medical Devices, Inc. |
Laurence Marsteller |
| K163115 |
11/07/2016 |
GC70 |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K163215 |
11/16/2016 |
AnemoCheck |
SANGUINA, LLC |
ERIKA TYBURSKI |
| K163099 |
11/07/2016 |
My Dose Coach |
Sanofi, Inc. |
Robert Ezzell |
| K163078 |
11/03/2016 |
DC-UIBC-CAL |
SEKISUI DIAGNOSTICS P.E.I. INC. |
PENNY WHITE |
| K163366 |
11/30/2016 |
Shanghai Sanyou CARMEN Cervical Fusion System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K160092 |
01/15/2016 |
Digital Electrocardiograph |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Hongbo Zhong |
| K163135 |
11/08/2016 |
Finger Pulse Oximeter |
SHENZHEN FITFAITH TECHNOLOGY CO.,LTD |
Yuan Junfeng |
| K163288 |
11/22/2016 |
Pelvifine Pelvic Muscle Trainer |
Shenzhen Konmed Technology Co., Ltd. |
Tony Tony |
| K160019 |
01/05/2016 |
U80 Series Upper Arm Electronic Blood Pressure Monitor |
SHENZHEN URION TECHNOLOGY CO.,LTD |
AUTUMN LIU |
| K160106 |
01/19/2016 |
LUNA DENTAL IMPLANT SYSTEM |
SHINHUNG MST Co., Ltd |
Sunbyung Lee |
| K163306 |
11/23/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
Plessy Paul |
| K160086 |
01/15/2016 |
SHOFU Enamel Conditioner |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K163220 |
11/16/2016 |
Atellica CH Phencyclidine (Pcp) |
Siemens Healthcare Diagnostics, Inc. |
Laura J. Duggan |
| K160202 |
01/28/2016 |
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Laura J. Duggan |
| K163286 |
11/22/2016 |
ARTIS pheno |
SIEMENS MEDICAL SOLUTION USA, INC. |
PATRICIA D. JONES |
| K163285 |
11/22/2016 |
syngo Application Software |
SIEMENS MEDICAL SOLUTION USA, INC. |
PATRICIA D. JONES |
| K163252 |
11/18/2016 |
Mammomat Fusion with Stereotactic Biopsy |
SIEMENS MEDICAL SOLUTIONS USA, INC |
Denise Adams |
| K163234 |
11/17/2016 |
Biograph mMR with syngo MR E11P system software |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K163312 |
11/23/2016 |
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K163211 |
11/16/2016 |
MAGNETOM Sempra with syngo MR E11S |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K163297 |
11/22/2016 |
Scan&GO |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K163296 |
11/22/2016 |
SOMATOM go.Up, SOMATOM go.Now |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K163284 |
11/22/2016 |
syngo. CT Neuro Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K163341 |
11/29/2016 |
syngo.CT Extended Functionality |
SIEMENS MEDICAL SOLUTIONS USA, Inc. |
Kimberly Mangum |
| K163294 |
11/22/2016 |
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L. FIELDS |
| K163289 |
11/22/2016 |
syngo. CT Single Source Dual Energy (twin beam) |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
Kimberly Mangum |
| K163081 |
11/03/2016 |
40-42mm BiPolar Head and 22mm Femoral Head |
SIGNATURE ORTHOPAEDICS PTY LTD. |
Declan Brazil |
| K160159 |
01/27/2016 |
Active-X Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K160095 |
01/19/2016 |
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz |
Simple Science, LLC |
Eoin Croke |
| K163257 |
11/14/2016 |
VitreOx Anti-fog Solution |
SiO2 Nanotech, LLC |
CLARIZZA WATSON |
| K160099 |
01/19/2016 |
CEREC SpeedGlaze |
Sirona Dental Systems GmbH |
Thomas Diesch |
| K163086 |
11/03/2016 |
VLP MINI-MOD 2.0mm Column Plates |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K163172 |
11/14/2016 |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
SMITHS MEDICAL ASD, INC. |
Bruce Backlund |
| K163212 |
11/16/2016 |
Parietene DS Composite Mesh |
Sofradim Production |
Benjamin Rochette |
| K163073 |
11/02/2016 |
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder |
Sol-Millennium Medical, Inc. |
Jim Barley |
| K160069 |
01/13/2016 |
Sonoma Fibula Repair System |
Sonoma Orthopedics Products, Inc |
Rick Epstein |
| K163063 |
11/02/2016 |
UC-5000 Mobile X-Ray |
SOURCE-RAY, INC. |
RAY MANEZ |
| K163060 |
11/01/2016 |
Deep Conical (DC) Implants and Accessories |
SOUTHERN IMPLANTS (PTY) LTD |
LAURANDA BREYTENBACH |
| K163292 |
11/22/2016 |
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford |
SPECTRA MEDICAL DEVICES |
SCOTT HENDERSON |
| K163339 |
11/28/2016 |
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 |
SPECTRALMD, INC. |
J. MICHAEL DIMAIO |
| K160120 |
01/19/2016 |
D-SPECT Processing and Reviewing Workstation |
SPECTRUM DYNAMICS LTD. |
YORAM LEVY |
| K163246 |
11/18/2016 |
Leva Anterior Expandable Spacer System |
SPINE WAVE, INC. |
AMY NOCCIOLI |
| K160003 |
01/04/2016 |
Sniper (R) Spine System |
SPINE WAVE, INC. |
KELLY Barbieri |
| K160074 |
01/14/2016 |
Rampart D Lumbar Interbody Fusion Device |
Spineology Inc. |
Karen Roche |
| K160124 |
01/20/2016 |
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System |
SpineVision S.A. |
Helene Plas |
| K160218 |
01/29/2016 |
AutoMark Module |
St. Jude Medical |
Melissa Frank |
| K160210 |
01/28/2016 |
EnSite Precision Cardiac Mapping System v2.0 |
ST. JUDE MEDICAL |
Marlene Peterson |
| K160187 |
01/27/2016 |
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 |
ST. JUDE MEDICAL |
MELISSA FRANK |
| K160186 |
01/27/2016 |
EnSite Velocity Surface Electrode Kit |
ST. JUDE MEDICAL |
YUMI WACKERFUSS |
| DEN160005 |
01/28/2016 |
Hem-Avert Perianal Stabilizer |
STETRIX, INC. |
MARK BUCHANAN |
| K160016 |
01/05/2016 |
Steth IO |
STRATOSCIENTIFIC, INC. |
SUMAN MULUMUDI |
| K160050 |
01/11/2016 |
SERFAS 90-S Electrosurgical Probe |
STRYKER CORPORATION |
SOMI EKWEALOR |
| K163259 |
11/21/2016 |
AXS Offset Delivery Assist Catheter |
STRYKER NEUROVASCULAR |
Shazia Hakim |
| K160096 |
01/19/2016 |
InZone Detachment System |
STRYKER NEUROVASCULAR |
KATE TAYLOR |
| K160057 |
01/12/2016 |
ArcCHECK-MR |
Sun Nuclear Corporation |
James Luker |
| K160190 |
01/27/2016 |
Sunmed Control Syringes |
Sunny Medical Device (Shenzhen) Co.,Ltd. |
James Qi Zhang |
| K160031 |
01/07/2016 |
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) |
SUNRISE MEDICAL (US) LLC |
LAURIE H ROBERTS |
| K163363 |
11/30/2016 |
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System |
SurgTech Inc. |
Xuegong Yu |
| K160097 |
01/19/2016 |
Image Fast Set, Image Regular Set |
Sybron Dental Specialties |
Gerardo Lara |
| K160103 |
01/19/2016 |
Spetzler Malis Dual Illuminating Bipolar Forceps |
SYNERGETICS |
DAN REGAN |
| K160167 |
01/27/2016 |
DePuy Synthes TFNA Augmentation System |
Synthes (USA) Products, LLC |
Christopher J. Medberry |
| K163175 |
11/14/2016 |
Bel-Cypher Pro |
Takara Belmont Corporation |
Toshinori Kiyomatsu |
| K160056 |
01/12/2016 |
t:slim Insulin Delivery System |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K163121 |
11/08/2016 |
SmartUs EXT-1M/3M |
TELEMED |
YURY SOKOLOV |
| K160206 |
01/28/2016 |
VirtuoSaph Plus Endoscopic Vessel Harvesting System |
Terumo Cardiovascular Systems Corporation |
Tierra A Brown |
| K160109 |
01/19/2016 |
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber |
THAYER MEDICAL CORPORATION |
MEGHAN MCGOVERN |
| K160070 |
01/13/2016 |
Rheumatoid Factor (RF) Kit for use on SPAPLUS |
THE BINDING SITE GROUP, LTD. |
Jon Lauder |
| K160222 |
01/29/2016 |
OIC Cervical PEEK Spacer |
THE ORTHOPAEDIC IMPLANT COMPANY |
DOUGLAS FULTON |
| K160052 |
01/11/2016 |
CUR Model 1 |
Thimble Bioelectronics, Inc. |
Shaun Rahimi |
| K163269 |
11/21/2016 |
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device |
TITAN SPINE, LLC |
JANE RODD |
| K160113 |
01/19/2016 |
ST AIA-PACK hsE2 Calibrator Set |
TOSOH BIOSCIENCE, INC. |
ROBERT L WICK |
| K160211 |
01/28/2016 |
Wet Original Personal Lubricant |
TRIGG LABORATORIES D/B/A WET INTERNATIONAL |
ERICA LORING |
| K160177 |
01/27/2016 |
Gridlock Ankle Plating System |
Trilliant Surgical, LTD |
Jon Olson |
| K163095 |
11/04/2016 |
Lyme B. burgdorferi (IgG) MarStripe Test |
Trinity Biotech |
Kevin Lawson |
| K163322 |
11/25/2016 |
TZ SKULL PIN Adult |
TZ MEDICAL INC |
JOHN LUBISICH |
| K163193 |
11/15/2016 |
UTF Stem, reduced, #0, #00 |
UNITED ORTHOPEDIC CORPORATION |
GIMPEL CHIEN |
| K160045 |
01/08/2016 |
Heyman Packing Applicator Set |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K160021 |
01/05/2016 |
Varian Sterilization Boxes |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K163307 |
11/23/2016 |
Expro Elite Snare, Sympro Elite Snare |
Vascular Solutions, Inc. |
Jake Schultz |
| K163346 |
11/29/2016 |
MAZIC Duro |
VERICOM CO., LTD. |
Myung-Hwan Oh |
| K163232 |
11/17/2016 |
Vitrea View |
Vital Images, Inc |
Fei Li |
| K160150 |
01/21/2016 |
Vitrea CT Colon Analysis |
Vital Images, Inc. |
Alexis Erazo |
| K160179 |
01/27/2016 |
VivaChek Ino Blood Glucose Monitoring System |
VIVACHEK LABORATORIES, INC. |
Julie Zhou |
| K160001 |
01/04/2016 |
TraumaCad Mobile Release 2.0 |
Voyant Health Ltd |
Yael Guttentag |
| K163217 |
11/16/2016 |
GORE BIO-A Tissue Reinforcement |
W. L. GORE & ASSOCIATES, INC. |
Barbara L Smith |
| K163320 |
11/23/2016 |
LAP-Pump PP110 |
W.O.M. WORLD OF MEDICINE GMBH |
Soeren Markworth |
| K163051 |
11/01/2016 |
ClearLumen II Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K160170 |
01/27/2016 |
Lehman Manometry Catheter |
Wilson-Cook Medical, Inc. |
Doris A. Hawks |
| K163368 |
11/30/2016 |
FITBONE TAA |
WITTENSTEIN intens GmbH |
Hartmut Kampa |
| K160114 |
01/19/2016 |
Xspan Laminoplasty Fixation System |
X-SPINE SYSTEMS, INC. |
Kriss Anderson |
| K160085 |
01/15/2016 |
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System |
ZIMMER GMBH |
Roberto Tommasini |
