| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K151933 |
12/10/2015 |
BRX PRO Bruxism Guard |
12TH MAN TECHNOLOGIES, INC. |
ALEX STENZLER |
| DEN140044 |
02/19/2015 |
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) |
23andMe |
Kathy Hibbs |
| K143058 |
02/13/2015 |
PuraDerm Gel |
3-D Matrix, Inc. |
Lisa Spirio |
| K152060 |
12/01/2015 |
3M Attest Rapid Readout Biological Indicator 1295 |
3M COMPANY |
MATT MORTENSEN |
| K152078 |
12/04/2015 |
Implant Studio 2015 |
3Shape Medical A/S |
Hanne Nielsen |
| K152155 |
12/17/2015 |
ARCHITECT 2nd Generation Testosterone |
Abbott Laboratories |
Regina Xavier Kumar |
| K152442 |
12/17/2015 |
Freestyle Freedom Blood Glucose Monitoring Sytem |
ABBOTT LABORATORIES |
Sai Sriharshada Tatavarty |
| K152721 |
12/08/2015 |
Cytal Wound Matrix |
ACELL, INC |
THOMAS GILBERT |
| K143276 |
02/05/2015 |
Acumed Small Bone IM Nail System |
Acumed, LLC |
Nathan Wolf |
| K152417 |
12/01/2015 |
Adler MicroMed Laser Surgery Fibers |
ADLER MICROMED INC. |
BRIAN CHANDLER |
| K150233 |
02/26/2015 |
NIOX VERO Airway Inflammation Monitor |
AEROCRINE AB |
Kathleen Rickard |
| K141694 |
02/24/2015 |
AESCULAP ORTHOPILOT NEXT GENERATION |
AESCULAP IMPLANT SYSTEMS, LLC |
JULIE TOM WING |
| K150062 |
02/09/2015 |
Excia Total Hip System |
AESCULAP IMPLANT SYSTEMS, LLC |
JULIE TOM WING |
| K152639 |
12/11/2015 |
DR 600 |
AGFA HEALTHCARE N.V. |
Koren Vervoort |
| K150930 |
12/18/2015 |
Deployable Oxygen Generation System-Smaill (DOGS-S) |
AirSep Corporation |
Peter Weisenborn |
| K141123 |
02/27/2015 |
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM |
ALLIANCE PARTNERS, LLC. |
TIM LOHNES |
| K141945 |
02/03/2015 |
ECHOSTAR COMFORT 1.5T MRI |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
| K152968 |
12/30/2015 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC |
RENEE MURPHY |
| K143337 |
02/17/2015 |
CONELOG Titanium base CAD/CAM |
ALTATEC GMBH |
DENNIS PAPPAS |
| K152460 |
12/22/2015 |
Rectangular Corpectomy Cage |
Amendia, Inc. |
Bruce Hooper |
| K152291 |
12/17/2015 |
Sterisheet Sterilization Wrap |
ANDERSEN STERILIZERS, INC. |
WILLIAM K ANDERSEN |
| K150833 |
12/04/2015 |
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System |
ANDON HEALTH CO.,LTD |
Yi Liu |
| K151168 |
12/22/2015 |
Nexodyn AOS Wound Care Solution |
APR Applied Pharma Research SA |
Giorgio Reiner |
| K141559 |
02/27/2015 |
V-GUIDE FOR VENTRICULOSTOMIES |
ARC SURGICAL LLC. |
CRAIG PAGAN |
| K153313 |
12/11/2015 |
SpeedLock Knotless Fixation System |
ARTHROCARE CORPORATION |
LAURA KASPEROWICZ |
| K153344 |
12/17/2015 |
Asahi REXEED-S Series Dialyzer |
Asahi Kasei Medical Co., Ltd. |
Hidenobu Nakazawa |
| K152047 |
12/23/2015 |
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid |
ASCENSION ORTHOPEDICS |
WILLIAM GARZON |
| K152153 |
12/11/2015 |
MicroSpot Handpiece |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K152732 |
12/10/2015 |
AOS Small Fragment Plating System |
AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
Mark Steinhauer |
| K150787 |
12/02/2015 |
Universal Spike |
B. Braun Medical Inc. |
Tracy Maddock |
| K143632 |
02/13/2015 |
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens |
Bausch & Lomb Incorporated |
Jessica Burger |
| K153158 |
12/28/2015 |
Solution Administration Sets with 0.2 Micron Filter |
BAXTER HEALTHCARE CORPORATION |
GARY CHUMBIMUNE |
| K152852 |
12/22/2015 |
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) |
BAYER HEALTHCARE, LLC |
William R Walsh |
| K153210 |
12/21/2015 |
Defibrillator Analyzer Variable Load |
BC GROUP INTERNATIONAL, INC |
Mel Roche |
| K141468 |
02/27/2015 |
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) |
BD Biosciences |
Terrance Thiel |
| K142985 |
02/26/2015 |
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator |
BECKMAN COULTER, INC. |
Eimear Carr |
| K150815 |
12/17/2015 |
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit |
Becton, Dickinson and Company |
Catherine(Katie) Bessette |
| K153257 |
12/11/2015 |
BD FlowSmart Set, MiniMed Pro-Set |
BECTON, DICKINSON AND COMPANY |
MATTHEW TRACHTENBERG |
| K142888 |
02/20/2015 |
Fingertip Pulse Oximeter |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Lei Chen |
| K143150 |
02/05/2015 |
CO2 monitoring line with and without in-line filter |
BESMED HEALTH BUSINESS CORP. |
WINNIE CHUNG |
| K150300 |
12/11/2015 |
Liquichek Cardiac Markers Plus Control LT |
Bio-Rad Laboratories |
Elizabeth Platt |
| K151321 |
12/09/2015 |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
Bio-Rad Laboratories, Inc. |
Jackie Buckley |
| K151876 |
12/30/2015 |
Bio2 Fusion Implant System |
Bio2 Technologies, Inc |
Janet Krevolin |
| K152157 |
12/11/2015 |
LC Bead LUMI |
BIOCOMPATIBLES UK LTD |
April Kent |
| K151295 |
12/01/2015 |
Biodenta Customized Abutment - Titanium |
BIODENTA SWISS AG |
DAVID ELIER |
| K143005 |
02/19/2015 |
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 |
BioFire Diagnostics, LLC |
Kristen Kanack |
| K143080 |
02/17/2015 |
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System |
BioFire Diagnostics, LLC |
Kristen Kanack |
| K141798 |
02/19/2015 |
SYPHER SPACER SYSTEM |
BIOGENNIX, LLC |
MEREDITH MAY, MS, RAC |
| K152326 |
12/10/2015 |
Biomet Microfixation OmniMax MMF System |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K142823 |
02/25/2015 |
Biomet Microfixation Thoracic Fixation System |
BIOMET MICROFIXATION |
Lauren Jasper |
| K142882 |
02/10/2015 |
G7 Freedom and Offset Liners, Freedom Head, Size 32 |
Biomet, Inc. |
Becky Earl |
| K143192 |
02/12/2015 |
Vanguard 360 Revision Knee System |
Biomet, Inc. |
Jason Heckaman |
| K142432 |
02/20/2015 |
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit |
BIONESS, INC. |
Robert Schulz, RAC |
| K150722 |
12/02/2015 |
EnFocus 2300, EnFocus 4400 |
BIOPTIGEN, INC. |
Tammy B Carrea |
| K152889 |
12/30/2015 |
SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS |
BIORENEW LABS, LLC |
JON DAVID |
| K143705 |
02/20/2015 |
NeedleCam HD Visualization System |
BIOVISION TECHNOLOGIES, LLC |
DAVID SANSO |
| K150997 |
12/22/2015 |
RUBY STAR |
BISON MEDICAL CO., LTD |
SUN-WOO LEE |
| K153088 |
12/11/2015 |
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System |
BOSTON SCIENTIFIC CORPORATION |
ASHLEY SANTOS |
| K151840 |
12/16/2015 |
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire |
Boston Scientific Corporation |
Nikki M Wahlberg |
| K152401 |
12/04/2015 |
Stingray LP Catheter |
BOSTON SCIENTIFIC CORPORATION |
KURTIS HUNSBERGER |
| K140828 |
02/04/2015 |
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE |
BRAINREADER APS |
METTE MUNCH |
| K141285 |
02/19/2015 |
BUSSE EXTENSION SET |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K153298 |
12/10/2015 |
AccuCath Intravascular Catheter |
C.R. Bard, Inc. |
Casey Coombs |
| K152554 |
12/14/2015 |
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology |
C.R. Bard, Inc. |
Kerrie Hamblin |
| K150585 |
12/31/2015 |
Ascent 3D |
CAO GROUP, INC. |
Robert K Larsen |
| K150769 |
12/14/2015 |
Cardinal Health Trochanteric IM Nail System |
Cardinal Health |
Tatyana Bogdan |
| K151445 |
12/21/2015 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
MEGAN MIDDAUGH |
| K142858 |
02/09/2015 |
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K153492 |
12/24/2015 |
CareView 1800L |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
Leilei Li |
| K152467 |
12/09/2015 |
Touch Ultrasound |
CARESTREAM HEALTH, INC. |
CAROLYN L. WAGNER |
| K151255 |
12/30/2015 |
Navigator Aesthetic Delivery System |
CARTICEPT MEDICAL INC |
CARRIBETH RAMEY |
| K152162 |
12/24/2015 |
Myray- HYPERION X5 |
CEFLA S.C. |
Silvia Sansavini |
| K153148 |
12/01/2015 |
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
YON YU |
| K152211 |
12/01/2015 |
PCT System |
CENTINEL SPINE, INC. |
JESSICA STAUB |
| K151226 |
12/03/2015 |
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
CEPHEID |
Kerry J Flom |
| K143302 |
02/12/2015 |
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 |
CEPHEID |
KERRY J FLOM |
| K151672 |
12/21/2015 |
Cerner CareAware Event Management |
CERNER CORPORATION |
SHELLEY S. LOOBY |
| K143013 |
12/11/2015 |
Spinal Inner Fixation System |
Changzhou Dingjian Medical Appliance Co., Ltd |
Li Quinsong |
| K151062 |
12/17/2015 |
WASTON Metallic Intramedullary Nail System |
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD |
Jack Lu |
| K153085 |
12/21/2015 |
Q Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
Qifei Liu |
| K152515 |
12/18/2015 |
TOMCAT Cervical Spinal System |
CHOICE SPINE, LP |
Kim Finch |
| K152146 |
12/08/2015 |
High Speed Handpieces and Accessories |
CODENT TECHNICAL INDUSTRY CO., LTD. |
Chin-Ting Wen |
| K151126 |
12/18/2015 |
Foresight Intracardiac Echocardiography (ICE) System |
Colibri Technologies Inc. |
SAM MOSTAFAVI |
| K152243 |
12/09/2015 |
One Coat 7 Universal |
Coltene/Whaledent AG |
Silke Wallaschek |
| K153499 |
12/18/2015 |
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension |
ConMed Corporation |
Dionne Sanders |
| K152860 |
12/29/2015 |
HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL |
CONMED CORPORATION |
LISA ANDERSON |
| K142716 |
02/10/2015 |
VCARE |
CONMED CORPORATION |
ANNA D'LIMA |
| K150668 |
12/09/2015 |
Biodesign Enterocutaneous Fistula Plug |
COOK BIOTECH INCORPRATED |
Perry W Guinn |
| K150748 |
12/18/2015 |
Flexipet Denuding Pipette, Flexipet Manipulation Pipette |
COOK INCORPORATED |
NAOMI FUNKHOUSER |
| K150931 |
12/18/2015 |
MReye Embolization Coils |
Cook Incorporated |
Nozomi Yagi |
| K150964 |
12/18/2015 |
MReye Flipper Detachable Embolization Coil and Delivery System |
Cook Incorporated |
Nozomi Yagi |
| K143415 |
02/26/2015 |
Air Bubble Based Infuser (ABBI) |
CooperSurgical, Inc |
James Keller |
| K153092 |
12/21/2015 |
Ally Uterine Positioning System |
CooperSurgical, Inc. |
Roaida Johnson |
| K141382 |
02/10/2015 |
BIOS KING BIOCELLULOSE FILM |
CORELEADER BIOTECH CO., LTD. |
YA-WEN KUO |
| K152284 |
12/04/2015 |
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS |
COTTON HIGH TECH S.L. |
Anna Garcia |
| K151279 |
12/16/2015 |
Counter OTC TENS Device, Model CSD-737Z |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
Jiang Eagle |
| K143088 |
02/25/2015 |
GastriSail Gastric Positioning System |
COVIDIEN |
Debbie Peacock |
| K142128 |
02/23/2015 |
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR |
COVIDIEN |
SHANNON GREEN |
| K151381 |
12/11/2015 |
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye |
Covidien |
Danielle Mueller |
| K142296 |
02/24/2015 |
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula |
Covidien |
Danielle Mueller |
| K142298 |
02/13/2015 |
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff |
Covidien |
Kelsey Lee |
| K152586 |
12/30/2015 |
Beacon Fine Needle Fiducial System |
Covidien LLC |
RACHEL SILVA |
| K152306 |
12/11/2015 |
MotoBand┐ CP Implant System |
CROSSROADS EXTREMITY SYSTEMS, LLC |
VERNON HARTDEGEN |
| K151896 |
12/07/2015 |
Houdini Catheter |
Cruzar Medsystems, Inc. |
Tom Kramer |
| K151158 |
12/10/2015 |
ALP VasQcare Take Home System |
Currie Medical Specialties, Inc. |
Owen J Bry |
| K143105 |
02/23/2015 |
Picosure Workstation |
CYNOSURE, INC. |
Kelli McMillan |
| K143092 |
02/11/2015 |
Tensyn Plug |
DALLEN MEDICAL, INC. |
Al Memmolo |
| K142881 |
02/13/2015 |
DMRC Dual Cure Orthodontic Band Cement |
DANVILLE MATERIALS, LLC. |
Dong Hua |
| K140575 |
02/03/2015 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
TRISHIA DWYER |
| K142880 |
02/04/2015 |
DMRC Light Cure Orthodontic Adhesive System |
Daville Materials LLC |
Dong Hua |
| K151496 |
12/15/2015 |
Latitude-C Cervical Interbody Spacer System |
Degen Medical |
Craig Black |
| K152767 |
12/14/2015 |
OTC12D AUTO RADIOGRAPHIC SYSTEM |
DEL MEDICAL, INC. |
JOHN HARTZELL |
| K152322 |
12/16/2015 |
Resolve 2.0 |
DENALI CORPORATION |
Jan G Stannard |
| K142987 |
02/11/2015 |
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color |
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) |
Gerhard de Boer |
| K151926 |
12/14/2015 |
QuickRay HD Intraoral Sensor |
DENTERPRISE INTERNATIONAL, INC. |
CLAUDE BERTHOIN |
| K142313 |
12/10/2015 |
OneQ-SL Implant System |
DENTIS CO. LTD. |
Jeong Seop Keun |
| K142178 |
02/26/2015 |
PROROOT MTA WHITE, PROROOT MTA GRAY |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K140881 |
02/13/2015 |
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS |
DEPUY (IRELAND) |
NANCY FRIDDLE |
| K143362 |
02/03/2015 |
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister |
Devon Medical Products |
John Siegel |
| K152859 |
12/03/2015 |
Portable X-ray System (Model: MINIX-V / MINIX-S) |
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) |
YOUNGBAE KWON |
| K142228 |
02/09/2015 |
Heated Eye Pad |
Digital Heat Corporation |
John Devine |
| DEN150010 |
12/08/2015 |
Dignitana AB DigniCap System |
DIGNITANA AB |
JAN RICHARDSSON |
| K143127 |
02/13/2015 |
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style |
DISPO-MED (MALAYSIA) SDN BHD |
NC LEOW |
| K141410 |
02/19/2015 |
ORAGENE DX OGD-500.001 |
DNA GENOTEK, INC. |
DAN FULLERTON |
| K152508 |
12/31/2015 |
Ageless Health Medical Digital Thermometer |
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
VICTOR WAN |
| K152172 |
12/14/2015 |
Econsole1 |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K140990 |
02/27/2015 |
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
TINA WU |
| K142064 |
02/13/2015 |
GALILEO NT |
EB NEURO, S.P.A. |
ALLISON SCOTT, RAC |
| K150190 |
02/26/2015 |
IntraTemp Solution Warmer |
Ecolab Inc. |
Michelle Nivala |
| K142511 |
02/20/2015 |
U50 Diagnostic Ultrasound System |
EDAN INSTRUMENTS, INC. |
CHERRY SUN |
| K140579 |
02/06/2015 |
ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K151878 |
12/01/2015 |
Video Colposcope |
EDAN INSTRUMENTS, INC. |
Queena Chen |
| K142576 |
02/26/2015 |
Spinal System |
EISERTECH, LLC |
Lukas Eisermann |
| K153011 |
12/11/2015 |
iViewDose R1.0 |
Elekta Limited |
Maurice Paine |
| K151686 |
12/30/2015 |
HumanPen Ergo II |
ELI LILLY AND COMPANY, INC. |
CHRISTINE A. PHILLIPS |
| K152370 |
12/22/2015 |
PRECICE Trauma Nail System |
Ellipse Technologies Incorporated |
John McIntyre |
| K133019 |
02/20/2015 |
FIBERION OPHTHALMIC ENDOLASER PROBE |
EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM |
MEHMET MELEK |
| K152182 |
12/10/2015 |
Fuse Gastroscopy System |
ENDOCHOICE INC. |
DANIEL HOEFER |
| K151567 |
12/23/2015 |
ENDOPLUS hand-held laparoscopic instruments |
ENDOPLUS |
Matthew Gudeman |
| DEN150005 |
12/18/2015 |
Newa Skin Therapy System |
EndyMed Medical Ltd. |
Yoram Levy |
| K150020 |
02/25/2015 |
Irritrol, EDS Combo-Rinse |
ESSENTIAL DENTAL SYSTESM, INC. |
JEFFREY WAN |
| K132868 |
02/20/2015 |
CARRICELL |
ETEX CORPORATION |
MICHAEL STRUNK, PHD. |
| K141492 |
02/06/2015 |
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) |
EUROSETS S.R.L. |
MARIO GENNARI |
| K143576 |
02/27/2015 |
Exactech Ambassador |
EXACTECH, INC. |
DAWN DAVISSON |
| K143402 |
02/04/2015 |
Extremity Medical Calcaneal Osteotomy Device |
EXTREMITY MEDICAL LLC |
Brian Smekal |
| K150166 |
02/23/2015 |
Extremity Medical Suture Anchor |
EXTREMITY MEDICAL LLC |
Brian Smekal |
| K141401 |
02/20/2015 |
EASY OUT |
FEET FOR LIFE PODIATRY CENTER |
MICHAEL HORWITZ |
| K141666 |
02/03/2015 |
FERTILIGENT SLOW RELEASE IUI CATHETER KIT |
FERTILIGENT, LTD |
BABACAR DIOUF |
| K152406 |
12/23/2015 |
SalivaMAX |
FORWARD SCIENCE LLC |
Brian Pikkula |
| K150708 |
12/10/2015 |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
| K143228 |
02/26/2015 |
Ancora LLC Interbody Fusion Device |
FRONTIER MEDICAL DEVICES, INC. |
ERIC SEABORG |
| K153483 |
12/15/2015 |
Balloon controller PB-30 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Aaron Ge |
| K134046 |
02/12/2015 |
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K152722 |
12/08/2015 |
neoV980 & neoV1470 Diode Lasers |
G.N.S NEO LASER LTD. |
GIL SHAPIRA |
| K150408 |
12/14/2015 |
V-STEADY, V-FAST |
G21 S.R.L. |
MAURIZIO FORONI |
| K152528 |
12/02/2015 |
Attachable Cath Lab Hemostasis Valve |
GALT MEDICAL CORP. |
DAVID DERRICK |
| K142472 |
02/10/2015 |
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems |
GE Healthcare |
Tracey Ortiz |
| K143251 |
02/04/2015 |
SIGNA Creator, SIGNA Explorer |
GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) |
GLEN SABIN |
| K143270 |
02/18/2015 |
Optima XR646 |
GE HUALUN MEDICAL SYSTEMS CO. LTD |
Kenny Ma |
| K151063 |
12/15/2015 |
Monitor B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
Sun YanLi |
| K141963 |
02/05/2015 |
12SL ECG ANALYSIS PROGRAM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
| K150354 |
12/10/2015 |
PAPAYA 3D Plus |
GENORAY CO., LTD. |
Kyoung-hwa Kim |
| K150782 |
12/14/2015 |
AbStats Gateway |
GI Logic Inc |
James Beeton |
| K142498 |
02/26/2015 |
MAGNIFY and MAGNIFY-S Spacers |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K150179 |
02/25/2015 |
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
BEN CHEN |
| K150024 |
02/20/2015 |
Bissinger Monopolar Cables |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
Matthias Bissinger |
| K152219 |
12/17/2015 |
PK AIM |
GYRUS ACMI INC |
NEIL KELLY |
| K150966 |
12/04/2015 |
HMB32 |
HAEMOPHARM BIOFLUIDS SRL |
GIUSEPPE TOMASINI |
| K141429 |
02/23/2015 |
SORRENTO BONE GRAFT SUBSTITUTE |
HAIDER BIOLOGICS, LLC |
GUSTAVO R PRADO |
| K143183 |
02/17/2015 |
Maxima XTEND Handpiece Maintenance System |
HANDPIECE HEADQUARTERS |
Timothy Ropchan |
| K142476 |
02/17/2015 |
Master Caution Device MCD |
HealthWatch Ltd. |
Yoram Levy |
| K142731 |
02/27/2015 |
HEARTWAY Electrically Powered Wheelchairs |
HEARTWAY Medical Products Co., Ltd. |
Dr. Ke-Min Jen |
| K151127 |
12/08/2015 |
higi Station |
higi SH LLC |
Colin Hill |
| K153223 |
12/09/2015 |
ProParaFlu+ Assay |
HOLOGIC, INC. |
RON DOMINGO |
| K151133 |
12/09/2015 |
PENTRA XLR |
HORIBA ABX SAS |
Caroline Ferrer |
| K143015 |
02/25/2015 |
Hospira Primary Sets |
Hospira, Inc. |
Anju Kurian |
| K143431 |
02/20/2015 |
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) |
i-codi Co., Ltd |
Yoo Hwan Park |
| K151025 |
12/29/2015 |
iHearTest |
IHEAR MEDICAL, INC. |
ANGELA LEE FOREMAN |
| K143500 |
02/06/2015 |
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set |
Immunalysis Corporation |
Joseph Ginete |
| K141803 |
02/12/2015 |
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY |
Immunalysis Corporation |
joseph Ginete |
| K143323 |
02/26/2015 |
OS2-V Varisation Staple |
IN2Bones SAS |
MORGANE GRENIER |
| K143563 |
02/03/2015 |
Infusion Aspiration Catheter System |
Inari Medical, Inc. |
Eben Gordon |
| K142244 |
02/06/2015 |
CLEO PATIENT MONITOR |
INFINIUM MEDICAL |
SULEYMAN BILGUTAY |
| K152491 |
12/17/2015 |
MoMe Software Platform |
INFOBIONIC, INC. |
MATTHEW KING |
| K152996 |
12/17/2015 |
Molteno3 Glaucoma Implant |
INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) |
BRYAN WEINMANN |
| K141274 |
02/13/2015 |
QUANTA FLASH ┐2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-┐2GPI DOMAIN1; CONTROLS. |
INOVA DIAGNOSTICS, INC. |
Roger Albesa |
| K152875 |
12/21/2015 |
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K141328 |
02/12/2015 |
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K150174 |
02/26/2015 |
EMMA |
INRANGE SYSTEMS, INC. |
Christopher E Bossi |
| K150877 |
12/13/2015 |
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
Instrumentation Laboratory Co. |
Carol Marble |
| K150682 |
12/18/2015 |
CUSA Excel+ |
INTEGRA LIFESCIENCES CORP. |
JENNIFER SIEGEL |
| K142956 |
02/24/2015 |
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit |
Integrated Healing Technologies |
Ian Baird |
| K141922 |
02/27/2015 |
IRIS INTELLIGENT RETINAL IMAGING SYSTEM |
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC |
RYAN BOUCHARD |
| K151364 |
12/28/2015 |
Intellijoint HIP(tm) System |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K152112 |
12/29/2015 |
VisualEyes |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K152436 |
12/07/2015 |
Suntanning Lamps |
Interlectric Corporation |
Ken C. Frazier |
| K141087 |
02/12/2015 |
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF |
INTERSURGICAL INCORPORATED |
MICHAEL ZALEWSKI |
| K152150 |
12/18/2015 |
V8 Balloon Aortic Valvuloplasty Catheter |
InterValve, Inc. |
Mark Ungs |
| K153126 |
12/09/2015 |
da Vinci Xi Hasson Cone |
INTUITIVE SURGICAL INC. |
VISHAL KANANI |
| K142937 |
02/24/2015 |
Endoscope Sterilization Tray |
INTUITIVE SURGICAL, INC. |
Nadine Nasr |
| K152330 |
12/23/2015 |
Expression MR400 MRI Patient Monitoring System |
INVIVO CORPORATION |
Rusty Kelly |
| K142374 |
02/13/2015 |
ivWatch Model 400 |
ivWatch, LLC |
Javier Garriz |
| K140045 |
02/18/2015 |
BODY COMPOSITION ANALYZER |
JAWON MEDICAL CO., LTD. |
W S PARK |
| K150009 |
02/25/2015 |
Baide |
Jiangsu Baide Medical Intrument Co.,Ltd. |
Mr.Kang Shui |
| K151074 |
12/22/2015 |
Magnetic Reasonance Imaging System |
JIANGSU MAGSPIN INSTRUMENT CO.,LTD |
LEO LI |
| K152323 |
12/14/2015 |
Disposable Infusion Needle, Safelock Disposable Infusion Needle |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
JUN LU |
| K151991 |
12/11/2015 |
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
| K151481 |
12/21/2015 |
Sahara Stabilization System |
K2M, INC |
NANCY GIEZEN |
| K143350 |
02/25/2015 |
Nile Alternative Fixation |
K2M, Inc. |
Nancy Giezen |
| K152644 |
12/31/2015 |
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 |
KEELER LIMITED |
IRINA PROUTSKI |
| K141738 |
02/17/2015 |
MEDEOR MATRIX WOUND DRESSING |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
BRIANNA JORDAN |
| K152441 |
12/04/2015 |
KIRO Set |
KIRO ROBOTICS S.L. |
Naiara Telleria |
| K143131 |
02/12/2015 |
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K143439 |
02/27/2015 |
KATANA Zirconia |
KURARAY NORITAKE DENTAL, INC. |
Michio Takigawa |
| K142623 |
02/26/2015 |
PANAVIA SA Cement Plus Handmix |
KURARAY NORITAKE DENTAL, INC. |
Michio Takigawa |
| K150817 |
12/21/2015 |
Dario Blood Glucose Monitoring System |
LabStyle Innovations Ltd. |
TRACEY WIELINSKI |
| K150841 |
12/29/2015 |
Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant |
LACLEDE, INC. |
Michael Pellico |
| K151934 |
12/07/2015 |
ROI-C Titanium-Coated Implant System |
LDR SPINE USA |
JAMES WILSON |
| K152175 |
12/04/2015 |
Upcera Dental Zirconia Blank for Aesthetic Restoration |
LIAONING UPCERA CO.,LTD |
Charles Shen |
| K141246 |
02/22/2015 |
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K141222 |
02/12/2015 |
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K142991 |
02/17/2015 |
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA |
LifeGlobal Group, LLC |
Michael D. Cecchi |
| K151611 |
12/14/2015 |
OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
LIFESCAN EUROPE |
NIKI SKELLY |
| K151370 |
12/17/2015 |
UV Lamps for Indoor Tanning Devices |
LIGHT SOURCES, INC. |
EUGENE CZAKO |
| K142172 |
02/27/2015 |
LIGHTMED TRUSCAN 577 |
LIGHTMED CORP. |
ANGEL HSIEH |
| K132220 |
02/20/2015 |
PJ'S SERENITY |
LIMERICK, INC. |
PATRICIA KELLY |
| K141205 |
02/13/2015 |
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K150934 |
12/21/2015 |
Powder Free Vinyl Patient Examination Glove (Non?-Sterile) |
LPL (HUI ZHOU) GLOVE |
LEE HONG CHONG |
| K152386 |
12/17/2015 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
TINA IP |
| K143635 |
02/20/2015 |
KINETIS Total Knee System |
MAKO SURGICAL |
JONATHAN REEVES |
| K153461 |
12/11/2015 |
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm |
MAQUET CRITICAL CARE AB |
Mirva Boothe |
| K151814 |
12/21/2015 |
SERVO-U Ventilator System, SERVO-n Ventilator System |
MAQUET CRITICAL CARE AB |
MARIA VON BAHR |
| K150831 |
12/22/2015 |
Cellvizio 100 Series System with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
Sophie Rehault |
| K143191 |
02/20/2015 |
IntelliSense Drill |
McGinley Innovations |
Joseph McGinley |
| K152201 |
12/30/2015 |
MedActive Oral Gel and Spray |
MedActive Oral Pharmaceuticals, LLC. |
Brian Walker |
| K142125 |
12/22/2015 |
New Medax Biopsy Systems |
MEDAX SRL UNIPERSONALE |
Stefano Cavalieri |
| K142167 |
02/20/2015 |
MEDENTIKA ABUTMENT SYSTEM |
MEDENTIKA GMBH |
LINDA SCHULZ |
| K141506 |
02/25/2015 |
MCC Para-Fix CARY BLAIR MEDIUM |
MEDICAL CHEMICAL CORPORATION |
KRIS J KONTIS |
| K143257 |
02/06/2015 |
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System |
MEDICATECH USA |
George Makar |
| K150049 |
02/10/2015 |
PASS LP Spinal System |
MEDICREA INTERNATIONAL |
Audrey Vion |
| K142345 |
02/22/2015 |
Talos-C(HA) Cervical Intervertebral Body Fusion Devices |
MEDITECH SPINE, LLC |
JASON GROMEK |
| K143111 |
02/19/2015 |
Codman Certas Plus Programmable Valve; Codman Certas Toll Kit |
MEDOS INTERNATIONAL SARL |
Michelle Godin |
| K143711 |
12/02/2015 |
Reaxon Plus |
MEDOVENT GMBH |
THOMAS FREIER |
| K151359 |
12/18/2015 |
ROSA Brain |
MEDTECH S.A. |
MICHAEL CHRIST |
| K143569 |
02/12/2015 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
GREGORY MASCHEK |
| K150178 |
02/11/2015 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC |
MICHAEL SCOTT |
| K143375 |
02/13/2015 |
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments |
MEDTRONIC SOFAMOR DANEK USA, INC |
Becky Ronner |
| K143628 |
02/12/2015 |
Navigated Vertex Select Instruments |
MEDTRONIC SOFAMOR DANEK USA, INC |
Tejas Patel |
| K143471 |
02/06/2015 |
VERTEX Reconstruction System |
Medtronic Sofamor Danek USA, Inc |
Lee Grant |
| K153463 |
12/30/2015 |
CD HORIZON Spinal System, IPC POWEREASE System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Becky Ronner |
| K150200 |
02/25/2015 |
CD HORIZON Growth Rod Conversion Set |
MEDTRONIC SOFAMOR DANEK USA, INCORPORATED |
LEE GRANT |
| K152121 |
12/01/2015 |
NuVent EM Sinus Dilation System |
MEDTRONIC XOMED, INC. |
Gabriela Anchondo |
| K150246 |
02/18/2015 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc |
Becky Severson |
| K141587 |
02/18/2015 |
E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA MAGNESON |
| K142451 |
02/09/2015 |
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K151762 |
12/28/2015 |
PediatrOS RigidTack/FlexTack |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K152783 |
12/07/2015 |
Merit 20 mL Syringe |
Merit Medical Systems, Inc. |
CORY MARSH |
| K142597 |
02/19/2015 |
Vienna System |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
Chuck Smith |
| K141516 |
02/05/2015 |
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
| K153071 |
12/23/2015 |
Solitaire Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Phuong Chau |
| K152001 |
12/10/2015 |
Sterile Repositionable Hemostasis Clipping Device |
Micro-Tech (Nanjing) CO.,Ltd. |
Becky Li |
| K153450 |
12/16/2015 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K142119 |
02/27/2015 |
PROCOTYL L-O ACETABULAR SYSTEM |
MICROPORT ORTHOPEDICS INC. |
BYRON LEDBETTER |
| K150870 |
12/21/2015 |
HydroPearl Microspheres, HydroPearl Microspheres |
MICROVENTION, INC. |
NAOMI GONG |
| K153053 |
12/29/2015 |
Traxcess Pro 14 Guidewire |
MICROVENTION, INC. |
SAPNA SINGH |
| K143222 |
12/11/2015 |
FIREFLY Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc |
Heidi Frey |
| K151396 |
12/09/2015 |
MIVI Mi-AXUS Guide Catheter |
MIVI NEUROSCIENCE, INC |
Matthew Ogle |
| K150898 |
12/18/2015 |
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm |
MOLLER MEDICAL GMBH |
JULIANE DRAGON |
| K143457 |
02/19/2015 |
NeuroBlate System |
MONTERIS MEDICAL, INC. |
Brooke Ren |
| K142459 |
02/03/2015 |
Ebony PTA 0.014 RX Peripheral Dilatation Catheter |
NATEC MEDICAL LTD |
Xavier de Buchere |
| K153228 |
12/04/2015 |
NMI Port, NMI Port II |
NAVILYST MEDICAL, INC. |
Robin Fuller |
| K150005 |
02/19/2015 |
Checkpoint, Checkpoint Head & Neck |
NDI Medical, LLC |
Robert Rogers |
| K150145 |
02/06/2015 |
MD322C8 31.5 Diagnostic Imaging LCD Monitor |
NEC DISPLAY SOLUTIONS LTD. |
SATORU KOTANI |
| K152857 |
12/17/2015 |
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps |
NEOMED, INC. |
TONY LAIR |
| K143135 |
02/20/2015 |
Spring Coil Guidewire |
NeoMetrics, Inc. |
Gene Champeau |
| K141316 |
02/13/2015 |
COGNISION EEG/EP SYSTEM |
NEURONETRIX SOLUTIONS |
CHERYL FISHER |
| K143230 |
02/25/2015 |
Palladian Lumbar Pedicle Screw System |
Neurostructures, Inc. |
Moti Altarac |
| K142774 |
02/18/2015 |
Polysmith Sleep System |
Neurotronics, Inc. |
David Pezet |
| K131335 |
02/03/2015 |
BWMINI EEG, BWMINIHST, BWMINI PSG |
NEUROVIRTUAL USA, INC. |
EDUARDO FARIA |
| K150729 |
12/29/2015 |
SpectraShield 9500 Surgical N95 Respirator |
Nexera Medical Inc. |
Paul Sallarulo |
| K150792 |
12/17/2015 |
Next Science Wound Gel |
NEXT SCIENCE, LLC |
MATTHEW MYNTTI |
| K152548 |
12/21/2015 |
AXI+LINE Proximal Bunion Correction System |
NEXTREMITY SOLUTIONS, Inc. |
Ryan Schlotterback |
| K150079 |
12/10/2015 |
Regenomer« Syringe, Regenomer« Plug, Regenomer« Block |
NIBEC CO, LTD |
YOON-JEONG PARK |
| K143678 |
02/06/2015 |
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory |
NINEPOINT MEDICAL, INC. |
SCOTT BLOOD |
| K143049 |
02/19/2015 |
LYNC intramedullary implant |
NOVASTEP |
Gilles Audic |
| K143229 |
02/06/2015 |
Nexis osteosynthesis compressive screws |
NOVASTEP |
Gilles Audic |
| K143146 |
02/06/2015 |
Nexis osteosynthesis snap-off screws |
NOVASTEP |
Gilles Audic |
| K152943 |
12/01/2015 |
NuVasive Foundation-LL System |
NUVASIVE INCORPORATED |
CYNTHIA ADAMS |
| K142205 |
02/20/2015 |
NuVasive X-CORE(R) Expandable VBR System |
NUVASIVE, INC. |
OLGA LEWIS |
| K150828 |
12/18/2015 |
O-RING Condom |
O-RING Products LLC |
William Mistler |
| K152945 |
12/15/2015 |
Alevicyn SG Antipruritic Gel |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
| K152809 |
12/31/2015 |
Giraffe Incubator Carestation CS1 |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
KENNY BELLO |
| K142785 |
12/17/2015 |
PRODIGY iConnect Blood Glucose Monitoring System |
OK BIOTECH CO., LTD. |
Jen Ke-Min |
| K142680 |
02/08/2015 |
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT |
OLYMPUS MEDICAL SYSTEMS CORP. |
Daphney Germain-Kolawole |
| K143303 |
02/27/2015 |
Single Use Biliary Balloon Dilator |
OLYMPUS MEDICAL SYSTEMS CORP. |
Sheri Musgnung |
| K153437 |
12/21/2015 |
Apex Revision Knee System |
OMNILIFE SCIENCE |
CHRISTINA ROVALDI |
| K141157 |
12/22/2015 |
BONDEASE TOPICAL SKIN ADHESIVE |
OPTMED, INC. |
STEPHANIE RAIS |
| K140913 |
02/17/2015 |
NUROS BONE GRAFT SUBSTITUTE |
ORIENTAL RESOURCES DEVELOPMENT LIMITED |
MICHAEL LEE |
| K153306 |
12/18/2015 |
Imbibe Needle |
ORTHOVITA, INC. |
LYNN LUNDY |
| K142358 |
02/19/2015 |
Osstell IDx |
OSSTELL AB |
KARIN BREDING |
| K152145 |
12/21/2015 |
OsteoMed ExtremiLOCK Wrist Plating System |
OSTEOMED |
Piedad Pena |
| K141911 |
02/10/2015 |
OPTIMUS NEURO SYSTEM |
OSTEONIC CO., LTD. |
Priscilla Chung |
| K152267 |
12/15/2015 |
Remedy« Shoulder Spacer |
Osteoremedies LLC |
Chris Hughes |
| K143395 |
02/23/2015 |
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit |
OTODYNAMICS, LTD. |
Julian Rutherford |
| K153378 |
12/21/2015 |
Monster BITE Screw System |
PARAGON 28 |
Frank S. Bono |
| K152951 |
12/28/2015 |
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray |
PARAGON MEDICAL, INC. |
MIKE GOSMEYER |
| K142848 |
02/24/2015 |
EAZY PRIMER |
Parkell, Inc. |
David Mott |
| K152636 |
12/17/2015 |
Laser Dock |
PATIENT POCKET, LLC |
ALLEN D SEFTEL |
| DEN140020 |
02/12/2015 |
ECLIPSE SYSTEM |
PELVALON |
CINDY DOMECUS |
| K152840 |
12/02/2015 |
Lantern Delivery Microcatheter |
PENUMBRA, INC. |
CHARLES DENAULT |
| K150854 |
12/14/2015 |
ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut |
PHADIA AB |
Carina Magnusson |
| K141375 |
02/13/2015 |
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 |
PHADIA US INC. |
MANUELA CONSTANZE HOG |
| K153480 |
12/16/2015 |
ClearVue850 Diagnostic Ultrasound System |
PHILIPS HEALTHCARE |
Saraswathi Deora |
| K153318 |
12/22/2015 |
Philips Eleva Workspot with SkyFlow |
Philips Medical Systems DMC GmbH |
MING XIAO |
| K151658 |
12/01/2015 |
Gmate Origin Blood Glucose Monitoring System |
Philosys Inc. |
LINDA CHAN |
| K143044 |
02/06/2015 |
CAAS A-Valve |
PIE MEDICAL IMAGING B.V. |
Florie Daniels |
| K142879 |
12/23/2015 |
BTM Wound Dressing |
POLYNOVO BIOMATERIALS PTY LTD |
Philip Powell |
| K151050 |
12/22/2015 |
Pacifier Activated Lullaby (PAL«) |
Power Medical Devices, LLC |
Patricia Palmer |
| K151413 |
12/18/2015 |
Always/Tampax bladder supports |
PROCTER & GAMBLE |
LENORE FAULHABER |
| K143514 |
12/11/2015 |
Panther StereoSeed |
PROWESS, INC. |
Rachel Scarano |
| K150806 |
12/16/2015 |
PulseFlowDF |
PulseFlow Technologies |
Les Lindsay |
| K152321 |
12/04/2015 |
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi |
QFIX |
NADIA SOOKDEO HARHEN |
| K152012 |
12/08/2015 |
EVO platform |
Quanta System SpA |
Francesco Dell'Antonio |
| K152714 |
12/21/2015 |
Quanta Forte |
QUANTA SYSTEM SPA |
FRANCESCO DELL'ANTONIO |
| K143126 |
02/06/2015 |
Renovis S141 Lumbar Interbody Cage System |
Renovis Surgical Technologies |
Josh Brown |
| K141434 |
02/18/2015 |
SATURN 5 LASER |
RESEARCH INSTRUMENTS LTD. |
DAVID LANDSDOWNE |
| K152292 |
12/07/2015 |
Respire Blue Series-EF |
Respire Medical Holding |
David Walton |
| K140980 |
02/10/2015 |
TI NASAL MASK |
RESPIRONICS, INC. |
SHAYLEE MASILUNAS |
| K152624 |
12/07/2015 |
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK |
REVMEDX, INC. |
AMY K. POINTER |
| K152542 |
12/24/2015 |
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs |
RIVERSTONE RESOURCES SDN BHD |
SURESH KUMAR |
| K141421 |
02/09/2015 |
PMMA BLOCK |
RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
HELEN NAN |
| K150092 |
02/10/2015 |
STERISPINE PS Pedicle Screw |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K143029 |
02/04/2015 |
Digital Diagnostic X-ray System (GC80) |
SAMSUNG ELECTRONICS CO., LTD. |
KIM CHULSIN |
| K150097 |
02/19/2015 |
GM60A-32S & GM60A-40S |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K153401 |
12/21/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K153408 |
12/21/2015 |
HM70A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
Jiyoung Kim |
| K152513 |
12/15/2015 |
8X-10-XXXX Camera System |
Santa Barbara Imaging Systems |
James Candy |
| K133268 |
02/12/2015 |
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
| K153189 |
12/17/2015 |
Beacon Tissue Marker (SE) |
SCION MEDICAL TECHNOLOGIES, LLC |
LOUIS LI |
| K142156 |
02/13/2015 |
SEEGENE ANYPLEX II HSV-1/2 ASSAY |
SEEGENE |
FRAN WHITE |
| K143382 |
02/23/2015 |
DentiAnn Smart Sil |
SeilGlobal Co., Ltd. |
Pack Seong Uk |
| K151639 |
12/07/2015 |
ABL80 FLEX and ABL80 FLEX CO-OX |
SENDX MEDICAL INC |
VIBEKE AGERLIN |
| K151329 |
12/17/2015 |
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet |
SENTEC AG |
ANKE WEISBRICH |
| K142924 |
02/13/2015 |
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family |
SHASER, INC. |
ANTHONY BURNS |
| K150664 |
12/22/2015 |
NeoLas |
SHEAUMANN LASER, INC |
Katina Sousa |
| K141946 |
02/13/2015 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Diana Hong |
| K152384 |
12/18/2015 |
Digital Electrocardiograph |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Hongbo Zhong |
| K151810 |
12/17/2015 |
Bpump Blood Pressure Cuff |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
XIE QIONGYU |
| K151699 |
12/10/2015 |
BEAUTIFIL II Enamel |
SHOFU DENTAL CORPORATION |
Mauro Malyzyner |
| K152451 |
12/11/2015 |
VINTAGE Art LF |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K142685 |
02/11/2015 |
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE |
SIAM SEMPERMED CORP., LTD |
ANAN PRUKSANUSAK |
| K142826 |
12/22/2015 |
ADVIA Centaur Toxoplasma M (Toxo M) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Matthew Gee |
| K153365 |
12/18/2015 |
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K143636 |
02/25/2015 |
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Donna Velasquez |
| K143373 |
02/26/2015 |
IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
DONNA VELASQUEZ |
| K151767 |
12/11/2015 |
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Laura J. Duggan |
| K150050 |
02/09/2015 |
ACUSON P500 Diagnostic Ultrasound System |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Shelly Pearce |
| K152283 |
12/24/2015 |
MAGNETOM Amira |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L FIELDS |
| K143319 |
02/24/2015 |
Syngo X-workplace SW VD10 |
Siemens Medical Solutions, Inc |
Patricia D. Jones |
| K143072 |
02/09/2015 |
ENROUTE Transcarotid Neuroprotection System |
SILK ROAD MEDICAL, INC |
Richard M Ruedy |
| K142436 |
02/19/2015 |
3S Safety Insulin Syringe |
Sincere Medical Device Co., Ltd. |
Garfield Wang |
| K142435 |
02/20/2015 |
3S Safety Syringe with/without Needle |
Sincere Medical Device Co., Ltd. |
Garfield Wang |
| K153208 |
12/31/2015 |
Internal Joint Stabilizer - Elbow |
SKELETAL DYNAMICS, LLC |
Ana M Escagedo |
| K150908 |
12/16/2015 |
XM-01 Electronic Automatic Blood Pressure Monitor |
Sky Innovation Technology ( Shanghai) Limited |
Charles Shen |
| K143172 |
02/04/2015 |
ACL SMART System |
SMITH & NEPHEW, INC. |
SAMIR IBRAHIM |
| K152566 |
12/02/2015 |
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor |
SMITH & NEPHEW, INC. |
KATHERINE MARCACCIO |
| K143226 |
02/12/2015 |
Visionaire Disposable Instruments |
SMITH & NEPHEW, INC. |
Shereen Bienz |
| DEN140024 |
12/23/2015 |
cNEP Airway |
Sommetrics |
Richard Rose |
| K152341 |
12/14/2015 |
ViSi Mobile Monitoring System |
SOTERA WIRELESS, INC |
Carson Krupp |
| K150201 |
02/27/2015 |
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter |
SPECTRANETICS, INC. |
Christine Godleski |
| K142996 |
02/19/2015 |
StaXx(R) XD System |
SPINE WAVE, INC. |
Roaida Johnson |
| K143214 |
02/23/2015 |
SCARLET« AC-T Secured Anterior Cervical Cage |
SPINEART |
Franck PENNESI |
| K143377 |
02/12/2015 |
PedFuse Pedicle Screw System |
SPINEFRONTIER, INC. |
Manthan J Damani |
| K152355 |
12/10/2015 |
Twin Peaks Lumbar Interbody Fusion System |
SPINEWAY |
Julien Thao my |
| K152958 |
12/04/2015 |
INEX Absorbable Nasal Implant |
SPIROX, INC. |
MIKE ROSENTHAL |
| K151114 |
12/11/2015 |
Medismart ( Latex Surgeon┐s Gloves powdered ) and Medismart + (Latex Surgeon┐s Gloves Powder Free, Polymer coated with protein |
ST.MARYS RUBBERS PVT. LTD. |
Srinivasan. S |
| K152115 |
12/17/2015 |
Renew NCP-5 External Counterpulsation System |
Stage 2 Innovations |
Richard Kotz |
| K140900 |
02/12/2015 |
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT |
Stanmore Worldwide Implants Ltd. |
SAMANTHA SHELLEY |
| K143260 |
02/23/2015 |
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider |
STERILMED, INC. |
NICOLE BOSER |
| K152651 |
12/15/2015 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
AAKASH JAIN |
| K152632 |
12/02/2015 |
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory |
STRYKER CORPORATION |
SORAYA KING |
| K150127 |
02/04/2015 |
Laparoscopic Handles with peek Insulation |
Stryker Endoscopy |
Rebecca Goldberg |
| K143085 |
02/09/2015 |
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach |
STRYKER ORTHOPAEDICS |
Denise Daugert |
| K152532 |
12/18/2015 |
AERO -C Cervical Cage System |
STRYKER SPINE |
SORAYA KING |
| K153154 |
12/28/2015 |
Asnis JFX System |
Stryker Trauma AG |
Garry T. Hayeck |
| K152692 |
12/21/2015 |
Powder Free Vinyl Patient Examination Gloves (Green) |
Supermax Plastic Products Co., Ltd |
Wu Zhigang |
| K150524 |
12/16/2015 |
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology |
Surgical Instrument Services and Savings, Inc |
Richard D Wynkoop |
| K142242 |
02/02/2015 |
PREMIUM, SHELTA Implant Systems |
SWEDEN & MARTINA S.P.A. |
GLORIANNA ZANGIACOMI |
| K143209 |
02/05/2015 |
SonicFill 2 |
SYBRON DENTAL SPECIALTIES |
KERRI CASINO |
| K151936 |
12/04/2015 |
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle |
SYNAPTIC MEDICAL LIMITED |
Yang Tiecheng |
| K143123 |
02/24/2015 |
Synergetics PHOTON EX |
Synergetics |
Dan Regan |
| K152239 |
12/02/2015 |
Zero-P Natural Plate System |
Synthes (USA), LLC |
Beth Becotte |
| K143469 |
02/12/2015 |
SOFTECH Plus ETCO2 Cannula |
TELEFLEX MEDICAL, INC. |
Brian Gall |
| K150148 |
02/20/2015 |
Terason uSmart3300 Ultrasound System |
TERATECH CORP. |
Steven R Broadstone |
| K153140 |
12/02/2015 |
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
JOSHUA P. EWING |
| K153376 |
12/16/2015 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Bryan Hann |
| K153143 |
12/02/2015 |
Capiox Advance Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Tierra A. Brown |
| K153213 |
12/03/2015 |
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Tierra A Brown |
| K152173 |
12/01/2015 |
Glidesheath |
TERUMO MEDICAL CORPORATION |
ERIN DOYLE |
| K141657 |
02/24/2015 |
THD REVOLUTION |
THD SPA |
MAURIZIO PANTALEONI |
| K152389 |
12/18/2015 |
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit |
THE BINDING SITE GROUP LTD |
STEPHANIE THOULESS |
| K143314 |
02/27/2015 |
Progressive Orthopaedic Total Hip System |
The Progressive Orthopaedic Company, LLC |
SCOTT KEISER |
| K150676 |
12/23/2015 |
L-Mesitran Dressing Family II- Soft and Tulle |
Theo Manufacturing BV |
Monique Gottgens |
| K143381 |
02/19/2015 |
Sensititre Susceptibility Plates |
Thermo Fisher Scientific |
Cynthia Knapp |
| K152774 |
12/21/2015 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K142894 |
02/03/2015 |
TCS Blend |
Thermoplastic Comfort Systems, Inc. |
Marilin Posca |
| K141504 |
02/24/2015 |
T-8000 THEROZONE UNIT |
THEROZONE USA, INC. |
Rebecca K Pine |
| K142767 |
02/03/2015 |
ThinkMed Intermittent Catheter with/without Hydrophilic Coating |
ThinkMed Medical Technology Co., Ltd. |
Garfield Wang |
| K153122 |
12/14/2015 |
Endoskeleton(r) TCS System |
TITAN SPINE, LLC |
Jane Rodd |
| K152202 |
12/14/2015 |
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm |
TNI Manufacturing, Inc. |
Daniel Sablyak |
| K152128 |
12/23/2015 |
2-in-1 Abdominal Muscle Training & Back Pain Relief System |
Tohkai Precision Electrical Manufactory (Shenzhen) Limited |
Yuk Wing Li |
| K150122 |
02/13/2015 |
TOMTEC-ARENA TTA2 |
TOMTEC IMAGING SYSTEMS, GMBH |
CHRISTINE KLEIN |
| K153417 |
12/18/2015 |
ST AIA-PACK PROG III Calibrator Set |
TOSOH BIOSCIENCE, INC. |
ROBERT L. WICK |
| K153310 |
12/17/2015 |
Klassic Knee System |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K150105 |
02/17/2015 |
Klassic Knee System-Sombrero Patella |
TOTAL JOINT ORTHOPEDICS, INC. |
Chris Weaber |
| K151916 |
12/18/2015 |
TRI Dental Implant System |
TRI DENTAL IMPLANTS INT. AG |
SANDRO VENANZONI |
| K141183 |
02/27/2015 |
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES |
TTBIO CORP. |
SHU-CHING LEE |
| K143417 |
02/25/2015 |
ANAX 5.5 Spinal System |
U&I Corporation |
Young-Geun Kim |
| K140949 |
02/09/2015 |
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE |
ULTIMED INCORPORATED |
MARY BETH HENDERSON |
| K150147 |
02/19/2015 |
Lubrigyn cream |
UNIDERM FARMACEUTICI SRL |
Giorgio Chiozza |
| K142832 |
02/06/2015 |
Unimed Disposable and Reusable SPO2 Sensors |
UNIMED MEDICAL SUPPLIES INC. |
Xinmei Tan |
| K153362 |
12/16/2015 |
AquaShield system CO2, AquaShield system-PENTAX |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K142248 |
02/20/2015 |
Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope |
Urologix, Inc. |
Georgiann Keyport |
| K150716 |
12/08/2015 |
Varaya Sport |
VARAYA PHOTOCEUTICALS, LLC |
Myk Lum |
| K151022 |
12/17/2015 |
Intraluminal Applicator Set |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K152387 |
12/18/2015 |
Fluent Inflation Device |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K143652 |
02/26/2015 |
Vector PTA Balloon Dilatation Catheter |
Vector Corporation LLC |
Jay Sturm |
| K150869 |
12/10/2015 |
Checkme Pro Health Monitor |
Viatom Technology Co., Ltd. |
Zhou Saixin |
| K142775 |
02/13/2015 |
Neuwater TM (HydrocynTM aqua) |
Vigilenz Medical Devices |
Shudipta Choudhury |
| K150992 |
12/16/2015 |
Vios Monitoring System |
VIOS MEDICAL, INC. |
MEGAN GRAHAM |
| K152373 |
12/30/2015 |
VITA VM LC Flow |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
Bernd Walker |
| K152139 |
12/06/2015 |
Vital Connect Platform, HealthPatch MD, VitalPatch |
VITAL CONNECT, INC. |
BONNIE WU |
| K150961 |
12/04/2015 |
EmbryoSlide Culture Dish |
VITROLIFE A/S |
BELINDA DUEHOLM |
| K150950 |
12/21/2015 |
FreezeKit Cleave , ThawKit Cleave |
VITROLIFE SWEDEN AB |
Brett Sonet Glazar |
| K152582 |
12/03/2015 |
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box |
VOLCANO CORPORATION |
NATHAN DA SILVA |
| K153369 |
12/22/2015 |
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz |
VOLCANO CORPORATION |
Brian Park |
| K153094 |
12/31/2015 |
Visions PV .035 Digital IVUS Catheter |
Volcano Corporation |
Neeta Sharma |
| K143122 |
02/20/2015 |
Volcano iFR Harvest Software (Offline) |
Volcano Corporation |
Neeta Sharma |
| K150162 |
02/26/2015 |
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test |
W.H.P.M., Inc. |
John Wan |
| K152609 |
12/11/2015 |
GORE SYNECOR Biomaterial |
W.L GORE & ASSOCIATES, INC. |
BARBARA L. SMITH |
| K150336 |
02/24/2015 |
Photonica Professional |
Ward Photonics LLC |
Terry Ward |
| K151900 |
12/11/2015 |
VariLift-L Interbody Fusion Device |
WENZEL SPINE, INC. |
BECKINAM NOWATZKE |
| K152851 |
12/24/2015 |
BrainPort V100 |
WICAB, INC. |
ROBERT BECKMAN |
| K152118 |
12/16/2015 |
Zenostar MT, Zenostar Color Liquids |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
| K152782 |
12/21/2015 |
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT |
WILLIAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K152904 |
12/03/2015 |
SYDNEY IVF EMBRYO BIOPSY MEDIUM |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
GORDANA POZVEK |
| K151714 |
12/03/2015 |
Disposable Endoscope Valves Set A |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
LIJUAN ZHANG |
| K152038 |
12/22/2015 |
MammoGRIP |
Women's Imaging Solutions Enterprises LLC |
Nancy DeRobertis |
| K150073 |
02/10/2015 |
MICRONAIL Distal Radius System |
Wright Medical Technology, Inc. |
Jeanine Redden |
| K152974 |
12/11/2015 |
ORTHOLOC« 3Di Foot Plating Reconstruction System |
Wright Medical Technology, Inc. |
Val Myles |
| K150640 |
12/01/2015 |
RX-FIX Mini Rail External Fixator |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K141982 |
02/05/2015 |
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
SARALA DEVI JAYARAMAN |
| K151890 |
12/23/2015 |
Medical Diode Laser Systems |
Wuhan Gigaa Optronics Technology Co., Ltd |
Nie Xinxing |
| K142479 |
02/24/2015 |
MEGNA BREAST PUMPS |
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. |
ANNE CHEN |
| K151284 |
12/21/2015 |
Electric Double Breast Pumps |
Wuxi Xinzhongrui Baby Supplies Co.,Ltd |
Shaozhong Chen |
| K152987 |
12/11/2015 |
Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System |
XENCO MEDICAL, LLC |
GUSTAVO PRADO |
| K143055 |
02/12/2015 |
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
Arivalagan Subramaniam |
| K143200 |
02/03/2015 |
MIS Z-Pedicle Screw System |
Z-Medical GmbH & Co. KG |
ALEXANDER HENNINGER |
| K151498 |
12/18/2015 |
Breathing circuit bacterial/viral filter |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
HU JUBIN |
| K143297 |
02/12/2015 |
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) |
Zimmer Spine, Inc. |
Donna M. Semlak |
| K151907 |
12/30/2015 |
Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K152484 |
12/04/2015 |
FastFrame External Fixation System - Distal Radius |
ZIMMER, INC. |
DOROTHY SNYDER |
| K152755 |
12/21/2015 |
FastFrame External Fixation System-Ankle Spanning |
Zimmer, Inc. |
Dorothy Snyder |
| K143618 |
02/06/2015 |
Kirschner Wires, Steinmann Pins |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K150028 |
02/06/2015 |
Zimmer Segmental System XT Components |
ZIMMER, INC. |
KEITH J. PROCTOR |
| K150121 |
02/23/2015 |
Zimmer Periarticular Plating System |
ZIMMER,INC. |
PATRICK MCCULLAGH |
| K142693 |
02/20/2015 |
ZywieAI Software Library |
Zywie, Inc. |
Latha Ganeshan |
