| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K162482 |
09/06/2016 |
A.B. DENTAL DEVICES Dental Implants System |
A. B. Dental Device Ltd. |
Gabi Krauss |
| K162554 |
09/13/2016 |
Gentrix Surgical Matrix |
Acell, Inc. |
Salman Elmi |
| K162579 |
09/15/2016 |
VascuCel |
Admedus Regen Pty Ltd |
Mary E. Donlin |
| K162596 |
09/16/2016 |
AIR OPTIX COLORS |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K162597 |
09/19/2016 |
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K162642 |
09/22/2016 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
ALERE SCARBOROUGH, INC. |
SARA HALLOWELL |
| K162529 |
09/09/2016 |
DigiX FDX |
Allengers Medical Systems Limited |
Manmohan Singh |
| K162721 |
09/29/2016 |
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
ALLIQUA BIOMEDICAL, INC. |
KATHY SIMPSON |
| K162574 |
09/15/2016 |
AmCAD-US |
AmCad BioMed Corporation |
Jack Yang |
| K162589 |
09/16/2016 |
Adscope 658 Electronic Stethoscope |
AMERICAN DIAGNOSTIC CORP. |
Michael Falco |
| K162668 |
09/26/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
LIU YI |
| K162449 |
09/01/2016 |
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) |
ANGIODYNAMICS, INC |
KASEY E NEWCOMB |
| K162676 |
09/26/2016 |
Voyant Open Fusion Device |
Applied Medical Resources |
Jessica Cho |
| K162461 |
09/02/2016 |
Endoform Plastics and Reconstructive Matrix |
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) |
Yasmin Rai |
| K162608 |
09/19/2016 |
ClariFix Device |
ARRINEX, INC. |
VAHID SAADAT |
| K162513 |
09/08/2016 |
Arterys Software v2.0 |
ARTERYS INC. |
GOLNAZ MOEINI |
| K162625 |
09/20/2016 |
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters |
B. BRAUN INTERVENTIONAL SYSTEMS INC. |
PETER FLOSDORF |
| K162562 |
09/14/2016 |
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY |
BCG MEDICAL, LLC |
LISA GIAP |
| K162740 |
09/30/2016 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) |
BECKMAN COULTER, INC. |
SHANNON POPSON |
| K162516 |
09/09/2016 |
BD Pen Needle |
BECTON, DICKINSON AND COMPANY |
MERIAM YOUSSEF |
| K162525 |
09/09/2016 |
Oniko nail brace |
BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI |
FATMA GULRU ERDOGAN |
| K162499 |
09/07/2016 |
Best Instruminal Applicator |
BEST MEDICAL INTERNATIONAL, INC. |
MANNY SUBRAMANIAN |
| K162689 |
09/27/2016 |
Vibrance Pelvic Trainer |
BIOINFINITY (M) SDN. BHD. |
NG SHEA KANG |
| K162737 |
09/30/2016 |
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4?g/mL) |
bioMerieux, Inc |
CHERECE L. JONES |
| K162559 |
09/14/2016 |
Move Forward 3D Motion Simulation Service |
BIOMET INC. |
PAUL HARDY |
| K162674 |
09/26/2016 |
BioPro Foot Plating Systems |
BIOPRO, INC. |
AL LIPPINCOTT |
| K162569 |
09/15/2016 |
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer |
BIOTECH LUBRICANTS LTD |
Sarah Brooks |
| K162571 |
09/15/2016 |
Bioflux Software |
Biotricity Inc. |
Tom Elias |
| K162598 |
09/19/2016 |
HAPI Seal |
BISCO, INC. |
Ryan Hobson |
| K162567 |
09/14/2016 |
ExactechGPS Total Shoulder Application, Equinoxe Planning Software |
Blue Ortho |
Anthony Boyer |
| K162487 |
09/07/2016 |
BSD3543 Digital Flat Panel X-ray Detector |
BONTECH INC. |
KWANG S. CHOI |
| K162523 |
09/09/2016 |
The IQool System |
BRAIN COOL AB |
MARTIN WALEIJ |
| K162723 |
09/29/2016 |
TransFix/EDTA Vacuum Blood Collection Tubes |
Caltag Medsystems Ltd. |
Daniel Harrison |
| K162503 |
09/07/2016 |
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software |
Cardiac Insight, Inc. |
Brad Harlow |
| K162568 |
09/14/2016 |
INTRABEAM 600 |
CARL ZEISS MEDITEC AG |
Christian Muenster |
| K162684 |
09/26/2016 |
SL 220 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K162456 |
09/02/2016 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
SCOTT A. CAMPBELL |
| K162566 |
09/14/2016 |
AIK Sterile Acupuncture Needles for Single Use |
CHANGCHUN AIK MEDICAL DEVICES CO., LTD |
XINGWANG LI |
| K162590 |
09/16/2016 |
Bashan TDP Heat Lamp |
Chogqing YUHE Medical Instruments Co., Ltd. |
Liu Yong |
| DEN160043 |
09/20/2016 |
Sentinel Cerebral Protection System |
Claret Medical, Inc. |
Zachary Woodson |
| K162609 |
09/19/2016 |
ClearPath Aligner |
ClearPath Orthodontics Ltd |
Waqas Wahab |
| K162563 |
09/14/2016 |
YOGA Microcatheter |
CODMAN & SHURTLEFF, INC. |
YOON HEE BEATTY |
| K162719 |
09/29/2016 |
iTotal« Hip Replacement System |
ConforMIS, Inc. |
Amita Shah |
| K162741 |
09/30/2016 |
AxoGuard Nerve Connector |
COOK BIOTECH INCORPORATED |
PERRY W. GUINN |
| K162729 |
09/29/2016 |
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip |
COOK INCORPORATED |
KOTEI AOKI |
| K162448 |
09/01/2016 |
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter |
Cook Incorporated |
Jessica Swafford |
| K162717 |
09/29/2016 |
Evolution Esophageal Stent System û Partially Covered |
Cook Ireland Ltd. |
Jane Kennedy |
| K162496 |
09/07/2016 |
Foundation 3D Interbody |
CoreLink, LLC |
Stephan Jones |
| K162515 |
09/08/2016 |
COSMED K5 Wearable Metabolic Technology |
COSMED S.r.l. |
Andrea Duca |
| K162738 |
09/30/2016 |
Puritan Bennett 980 Ventilator System |
Covidien |
Kelsey Lee |
| K162584 |
09/16/2016 |
VersaOne Bladeless Trocar |
COVIDIEN |
TRANG HUYNH |
| K162734 |
09/30/2016 |
CreoDent Solidex Customized Abutment |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K162506 |
09/08/2016 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K162695 |
09/27/2016 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K162682 |
09/26/2016 |
MATISSE Anterior Cervical Interbody Fusion Cage System |
CTL Medical Corporation |
Tosan Onosode |
| K162697 |
09/27/2016 |
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal |
Custom Orthopaedic Solutions, Inc. |
Keith Grafmeyer |
| K162512 |
09/08/2016 |
truSculpt |
CUTERA, INC. |
BRADLEY RENTON |
| K162727 |
09/29/2016 |
SENYINT Remote Consultation System |
Dalian Senyint Digital Medical System Co., Ltd. |
Yinghui Miao |
| K162654 |
09/23/2016 |
mollosil plus |
DETAX GmbH & Co.KG |
Antje Reeps |
| K162552 |
09/13/2016 |
EVS 3643, EVS 3643G |
DRTECH Corporation |
Choul-Woo Shin |
| K162555 |
09/13/2016 |
EVS 4343, EVS 4343G |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K162670 |
09/26/2016 |
RSM 1824C with RConsole1 |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K162509 |
09/08/2016 |
Infrared Non-contact Thermometer, Model ACT8100 |
EASYWELL BIOMEDICALS, INC. |
Arthur Chen |
| DEN160044 |
09/26/2016 |
Acumen Hypotension Prediction Index (HPI) Feature Software |
Edwards Lifesciences LLC |
Lisa Gilman |
| K162474 |
09/06/2016 |
Artemis |
EIGEN |
William Mandel |
| K162497 |
09/07/2016 |
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR |
EIZO CORPORATION |
Hiroaki Hashimoto |
| K162490 |
09/07/2016 |
Disc-FX System |
ELLIQUENCE LLC |
Paul D. Buhrke IV |
| K162627 |
09/20/2016 |
EnsoSleep |
EnsoData, Inc. |
Chris Fernandez |
| K162578 |
09/15/2016 |
Zerona Z6 OTC |
ERCHONIA CORPORATION |
STEVEN SHANKS |
| K162744 |
09/30/2016 |
Everyway OTC EMS, Model EV-805 |
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
PAUL HUNG |
| K162732 |
09/29/2016 |
Exactech« Alteon« HA Femoral Stem |
EXACTECH INC |
Thomas McNamara |
| K162726 |
09/29/2016 |
Exactech« Equinoxe« Preserve Stem |
EXACTECH INC |
Thomas McNamara |
| K162508 |
09/08/2016 |
KerraCel Ag Gelling Fiber Silver Dressing |
Exciton Technologies Inc. |
Melanie Ussyk |
| K162693 |
09/27/2016 |
VertebraLINK Fusion Platform |
FACETLINK DBA LINKSPINE |
MASSIMO CALAFIORE |
| K162767 |
09/30/2016 |
Sentinel BreastScan II System |
First Sense Medical, LLC |
Alan Alan Klevens |
| K162553 |
09/13/2016 |
AirSpiral Heated Breathing Tube |
FISHER & PAYKEL HEALTHCARE |
STEPHANIE ELVIN |
| K162582 |
09/15/2016 |
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit |
FISHER & PAYKEL HEALTHCARE |
Tina O'Brien |
| K162450 |
09/01/2016 |
ESPADA Acne-Clearing Blue Light Pen |
FOREO INC. |
Davor Soldo |
| K162462 |
09/02/2016 |
AMICUS Separator System, AMICUS Separator System; Refurbished |
FRESENIUS KABI USA LLC |
KIM FORCH |
| K162488 |
09/07/2016 |
Optiflux dialyzer |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K162716 |
09/29/2016 |
bibag |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
Denise Oppermann |
| K162622 |
09/20/2016 |
Fujifilm Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha More |
| K162749 |
09/30/2016 |
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha S. More |
| K162455 |
09/02/2016 |
Humelock Reversed Shoulder |
FX SOLUTIONS |
Jean-Jacques Martin |
| K162599 |
09/19/2016 |
IcePearl 2.1 CX L, IceForce 2.1 CX L |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K162743 |
09/30/2016 |
ViewPoint 6 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
| K162722 |
09/29/2016 |
HyperSense |
GE MEDICAL SYSTEMS, LLC |
GLEN SABIN |
| K162463 |
09/02/2016 |
Matrix Data Management System |
GLOBAL INSTRUMENTATION, LLC |
JASON DEMASO |
| K162618 |
09/20/2016 |
CONCORD Plus Radiopaque Bone Cement |
GLOBUS MEDICAL, INC. |
KELLY J. BAKER |
| K162707 |
09/28/2016 |
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
Golden Stapler Surgical Co., Ltd. |
Hao Chao |
| K162747 |
09/30/2016 |
Proture Double Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Jun Deng |
| K162471 |
09/06/2016 |
Hach CM130 Chlorine Monitoring System |
HACH COMPANY |
Jeff Ryberg |
| K162646 |
09/22/2016 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA NGC SDN. BHD. |
KUAN MUN LEONG |
| K162491 |
09/07/2016 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K162683 |
09/26/2016 |
RehaStim 2 |
HASOMED GmbH |
Matthias Ueltzen |
| K162583 |
09/15/2016 |
ALOKA LISENDO 880 |
HITACHI, LTD. |
ANGELA VAN ARSDALE |
| K162673 |
09/26/2016 |
Aptima Herpes Simplex Viruses 1 & 2 Assay |
HOLOGIC, INC. |
Ron Domingo |
| K162764 |
09/30/2016 |
JAZZ FRAME SYSTEM |
IMPLANET S.A. |
REGIS LE COUEDIC |
| K162633 |
09/21/2016 |
Custom Bars |
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
Reina Choi |
| K162753 |
09/30/2016 |
RTC 26-C Inline Aerosol Adapter |
INSTRUMENTATION INDUSTRIES, INC. |
Doris Walter |
| K162768 |
09/30/2016 |
ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables |
INTEGRAL PROCESS SAS |
Virginie S Grondin |
| K162624 |
09/20/2016 |
Pre-Formed Penile Silicone Block |
INTERNATIONAL MEDICAL DEVICES, INC. |
JAMES ELIST |
| K162621 |
09/20/2016 |
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair |
Invacare Corporation |
Elijah N. Wreh |
| K162696 |
09/27/2016 |
Kuschall Advance Manual Wheelchair |
INVACARE CORPORATION |
ELIJAH N. WREH |
| K162686 |
09/27/2016 |
Kuschall Champion Manual Wheelchair |
Invacare Corporation |
Elijah N. Wreh |
| K162692 |
09/27/2016 |
Kuschall K-Series Attract Manual Wheelchair |
INVACARE CORPORATION |
Elijah N. Wreh |
| K162679 |
09/26/2016 |
IOB Temperature Management System |
IOB MEDICAL INC |
JIULIN XIA |
| K162629 |
09/21/2016 |
IQM Integral Quality Monitor (also IQM) |
IRT SYSTEMS |
Juergen Oellig |
| K162478 |
09/06/2016 |
ivWatch |
ivWatch, LLC |
Jaclyn Lautz |
| K162600 |
09/19/2016 |
Jewel Precision Reusable Rigid Sterilization Container System |
JEWEL PRECISION SHEET METAL & MACHINE, INC. |
GARY SCHNEBERGER |
| K162517 |
09/09/2016 |
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 |
JKH Health Co., Ltd. |
Pu Jiang |
| K162664 |
09/26/2016 |
Pyrenees Cervical Plate System |
K2M, Inc. |
NANCY GIEZEN |
| K162759 |
09/30/2016 |
KeraStat(R) Gel |
KeraNetics, LLC. |
Luke Burnett |
| K162536 |
09/12/2016 |
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord |
KERR CORPORATION |
MOHAMMAD SAAD ANSARI |
| K162667 |
09/26/2016 |
Kitazato IUI Catheter |
Kitazato Corporation |
Mari Yazaki |
| K162504 |
09/07/2016 |
SKR 3000 |
KONICA MINOLTA, INC |
TSUTOMU FUKUO |
| K162511 |
09/08/2016 |
LELO RESPECT HEX Natural Rubber Latex Condom |
LELO INC. |
PAVLE SEDIC |
| K162652 |
09/23/2016 |
Smart Photon Micro-current Device, Model: EP-300 |
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION |
Barry Yuan |
| K162685 |
09/26/2016 |
2-Piece Hammertoe Correction System |
Life Spine, Inc. |
Randy Lewis |
| K162752 |
09/30/2016 |
ARTIA Reconstructive Tissue Matrix Perforated |
LIFECELL CORPORATION |
ANUJA YARDI |
| K162705 |
09/28/2016 |
VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit |
MAINE STANDARDS COMPANY LLC |
JAMES CHAMPLIN |
| K162603 |
09/19/2016 |
Masimo O3 Regional Oximeter System |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K162675 |
09/26/2016 |
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K162577 |
09/15/2016 |
Dosimetry Check Version 5 Release 1 |
MATH RESOLUTIONS, LLC |
WENDEL DEAN RENNER |
| K162469 |
09/02/2016 |
CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps |
Medos International SARL |
Jennifer Siu |
| K162604 |
09/19/2016 |
Cranial Reducing Tubes |
MEDTRONIC NAVIGATION, INC. |
Christopher Perman |
| K162655 |
09/23/2016 |
StealthConnect Remote Viewing, Planning and Collaboration System |
MEDTRONIC NAVIGATION, INC. |
MONICA R. MONTANEZ |
| K162494 |
09/07/2016 |
CD HORIZON« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Justin O'Connor |
| K162680 |
09/26/2016 |
SOVEREIGN« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KANESHA HINES |
| K162550 |
09/13/2016 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc. |
Brenna Loufek |
| K162687 |
09/27/2016 |
Paragon 2 |
MERIDIAN MEDICAL SYSTEMS, LLC |
Larry Cornell |
| K162635 |
09/21/2016 |
Distal Radius Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K162704 |
09/28/2016 |
Axium Prime Detachable Coil System |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Joyce Zhong |
| K162539 |
09/12/2016 |
Solitaire 2 Revascularization Device |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
JENNIFER CORREA |
| K162466 |
09/02/2016 |
LuminScan (TM) Imaging System |
MICRO-TECH (NANJING) CO.,LTD. |
Becky Li |
| K162459 |
09/02/2016 |
AccuPoint Electrode |
MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON |
Martin Bak |
| K162524 |
09/09/2016 |
AZUR CX Detachable 18 Peripheral Coil System |
MicroVention, Inc |
Laraine Pangelina |
| K162630 |
09/21/2016 |
CP Relief Wand-OTC |
Mid-America Medical Innovations LLC |
Norm Schroeder |
| K162748 |
09/30/2016 |
MindMotionPRO |
MindMaze SA |
SYLVAIN BOURRIQUET |
| K162570 |
09/15/2016 |
Miromatrix Biological Mesh TW |
Miromatrix Medical Inc. |
Jeff Ross |
| K162665 |
09/26/2016 |
MiCor A100 Wearable ECG Recorder |
MITAC INTERNATIONAL CORP. |
YIHAO HUANG |
| K162588 |
09/16/2016 |
M÷ller Medical Biopsy Needles and Systems |
Moller Medical GmbH |
Christoph Traxler |
| K162762 |
09/30/2016 |
NeuroBlate System |
Monteris Medical, Inc. |
David H. Mueller |
| K162651 |
09/23/2016 |
Breast BI 7 MR Coil Mammavention 3T |
MORAS MRI products GmbH |
Zahed Sedighiani |
| K162754 |
09/30/2016 |
FREND Vitamin D Test System |
NanoEnTek USA, Inc. |
Jimmy Chen |
| K162595 |
09/15/2016 |
Trex_HD |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K162681 |
09/26/2016 |
Enobio Wireless EEG |
Neuroelectrics Barcelona S.L.U. |
Anna Maiques |
| K162610 |
09/19/2016 |
NEXA Negative Pressure Wound Therapy System |
Nexa Medical Ltd. |
Keith Heaton |
| K162617 |
09/20/2016 |
NobleStitch EL |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
FAYE DUNN |
| K162602 |
09/19/2016 |
NovoPen Echo |
Novo Nordisk Inc. |
Elizabeth D'Amato |
| K162647 |
09/22/2016 |
NuVasive NuvaLine Mobile App |
NUVASIVE, INCORPORATED |
Olga Lewis |
| K162746 |
09/30/2016 |
Ontex and other proprietary names |
ONTEX BVBA |
Henri Lesage |
| K162638 |
09/22/2016 |
CETRA Anterior Cervical Plate System |
Orthofix Inc. |
Jacki Koch |
| K162446 |
09/01/2016 |
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System |
ORTHOFIX INC. |
JACKI KOCH |
| K162576 |
09/15/2016 |
FORTEZZA Spinal Stabilization System |
OSSO SURGICAL |
Basheer Hassan |
| K162542 |
09/12/2016 |
OsteoMed PINNACLE Driver |
OSTEOMED |
KATHRYN A. JAYNE |
| K162544 |
09/12/2016 |
OsteoMed PINNACLE Driver |
OSTEOMED |
KATHRYN A. JAYNE |
| K162662 |
09/26/2016 |
GingiDent Gingival Retraction Paste |
PAC-DENT INTERNATIONAL, INC. |
JIAQING WU |
| K162453 |
09/01/2016 |
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) |
Pan Medical Ltd. |
Jennie Budding |
| K162447 |
09/01/2016 |
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner |
PENTAX of America, Inc. |
Krishna Govindarajan |
| K162756 |
09/30/2016 |
PHAKOS Disposable Retinal Cryo Probe |
PHAKOS |
OLIVER AUMAITRE |
| K162549 |
09/13/2016 |
Lumify Ultrasound System |
Philips Healthcare |
Chuck Morreale |
| K162484 |
09/07/2016 |
Lung Nodule Assessment and Comparison Option (LNA) |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K162537 |
09/12/2016 |
CAD/CAMouflage Milling Block |
PRISMATIK DENTALCRAFT, INC. |
ALIVA DAS |
| K162623 |
09/20/2016 |
16ch T/R Hand Wrist Coil |
QUALITY ELECTRODYNAMICS, LLC |
KATHLEEN ARAS |
| K162451 |
09/01/2016 |
Solana HSV 1+2/VZV Assay |
QUIDEL CORPORATION |
Ronald H. Lollar |
| K162468 |
09/02/2016 |
ClearCheck |
RADFORMATION |
KURT SYSOCK |
| K162519 |
09/09/2016 |
1717WCC / 1717WGC |
RAYENCE CO., LTD |
KEVIN KIM |
| K162518 |
09/09/2016 |
1012WCC, 1012WGC |
RAYENCE CO., LTD. |
KEVIN KIM |
| K162481 |
09/06/2016 |
RF1400 Active Compression Wrap |
RECOVERY FORCE LLC |
Jeff Schwegman |
| K162620 |
09/20/2016 |
Remel Spectra ESBL |
REMEL, INC. |
CYNTHIA KNAPP |
| K162613 |
09/19/2016 |
Integrated Catch-up Freedom Syringe Driver Infusion System |
Repro-Med Systems, Inc., DBA RMS Medical Products |
Fred Ma |
| K162640 |
09/22/2016 |
iVitri EZ |
REPROBITECH CORP. |
Huai L. Feng |
| K162470 |
09/06/2016 |
RT300 FES cycle ergometer |
Restorative Therapies, Inc. |
Andrew Barriskill |
| K162677 |
09/26/2016 |
L- OVC |
Rhondium, Ltd |
Greer Fricker |
| K162526 |
09/09/2016 |
Creatine Kinase-MB |
ROCHE DIAGNOSTICS |
NOEL B. MENCIAS |
| K162678 |
09/26/2016 |
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl |
ROCHE DIAGNOSTICS |
Kelli Turner |
| K162606 |
09/19/2016 |
Elecsys TSH assay, cobas e 801 Immunoassay analyzer |
ROCHE DIAGNOSTICS |
ANGELO PEREIRA |
| K162593 |
09/16/2016 |
HDL-Cholesterol Gen.4 |
Roche Diagnostics Operations (RDO) |
Barbara McWhorter |
| K162457 |
09/02/2016 |
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit |
Rocket Medical Plc |
Tracy Charlton |
| K162531 |
09/09/2016 |
STERISPINE CC |
SAFE ORTHOPAEDICS |
SOPHIE REHAULT |
| K162543 |
09/12/2016 |
Reverse Pull Adjustable Facemask |
SAWBROS INDUSTRIES PVT.LTD. |
DHRUV SAWHNEY |
| K162715 |
09/29/2016 |
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K162565 |
09/14/2016 |
VIA 17 Microcatheter |
SEQUENT MEDICAL, INC. |
BETHANY BARRETT |
| K162659 |
09/26/2016 |
Diode Laser Hair Removal System |
SHANDONG HUAMEI TECHNOLOGY CO.,LTD. |
Xu QingHua |
| K162527 |
09/09/2016 |
8MP Color LCD Monitor (C81W+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K162479 |
09/06/2016 |
Smart Pain Reliever, Model LT5019 |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
TRUMAN SHEN |
| K162607 |
09/19/2016 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yanhong Bai |
| K162698 |
09/27/2016 |
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer |
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD |
Jie Rao |
| K162718 |
09/29/2016 |
Foot Drop System (Model XFT-2001D) |
SHENZHEN XFT Medical Limited |
JIANG XIAOYING |
| K162601 |
09/19/2016 |
Infusion Set for Single Use |
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD. |
Xiaolei Tian |
| K162733 |
09/29/2016 |
iFuse Implant System« - iFuse-3D implant |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K162538 |
09/12/2016 |
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS |
SUSAN FERRIN |
| K162540 |
09/12/2016 |
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls |
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH |
ROSE T MARINELLI |
| K162688 |
09/27/2016 |
Sysmex CS-2100i |
Siemens Healthcare Diagnostics Products GmbH |
Donna Noeh |
| K162541 |
09/12/2016 |
syngo Application Software |
SIEMENS MEDICAL SOLUTIONS USA, INC |
PATRICIA D. JONES |
| K162736 |
09/30/2016 |
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT |
Siemens Medical Solutions USA, Inc. |
ALAINE MEDIO |
| K162483 |
09/06/2016 |
Symbia Intevo Bold |
SIEMENS MEDICAL SOLUTIONS, USA, INC. |
Cynthia Busch |
| K162587 |
09/16/2016 |
ROCCIA« ACIF |
SILONY MEDICAL GMBH |
Bircan YILMAZ |
| K162641 |
09/22/2016 |
Smith & Nephew, Inc. R3Ö Constrained Liner |
Smith & Nephew, Inc. |
Natalie P. Williams |
| K162573 |
09/15/2016 |
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source |
SOURCE PRODUCTION AND EQUIPMENT CO., INC. |
KELLEY RICHARDT |
| K162561 |
09/14/2016 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters |
SPECTRANETICS, INC. |
PRISCILA TAPIA |
| K162750 |
09/30/2016 |
Libra Pedicle Screw System |
Spinal Balance, Inc. |
Anand Agarwal |
| K162639 |
09/22/2016 |
ProficientÖ Posterior Cervical Spine System |
Spine Wave, Inc. |
Sanja Jahr |
| K162760 |
09/30/2016 |
Spine Wave Anterior Cervical Spine System |
SPINE WAVE, INC. |
Amnon Talmor |
| K162694 |
09/27/2016 |
Ayers Rock Cervical interbody fusion system |
Spineway |
Nicolas Roth |
| K162611 |
09/19/2016 |
PeriFLEX |
SPIRATION, INC. |
Aadarsh S Viswanathan |
| K162500 |
09/07/2016 |
Ostial Sprit Cannulae |
SPYDER MEDICAL |
MICHAEL WEBB |
| K162643 |
09/22/2016 |
MediGuide Technology System |
ST. JUDE MEDICAL |
MARLENE PETERSON |
| K162701 |
09/28/2016 |
VERIFY Assert Self-Contained Biological Indicator |
STERIS CORPORATION |
ANTHONY PIOTRKOWSKI |
| K162758 |
09/30/2016 |
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K162631 |
09/21/2016 |
VERIFY STEAM Integrating Indicator - Short |
STERIS CORPORATION |
TRICIA CREGGER |
| K162702 |
09/28/2016 |
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table |
STL International, Inc. |
Rylie Teeter Leier |
| K162585 |
09/16/2016 |
SuniIQ Digital Radiography System |
Suni Medical Imaging, Inc |
Al Bettencourt |
| K162751 |
09/30/2016 |
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider |
Surgical Instrument Services and Savings, Inc |
Brandi J Panteleon |
| K162778 |
09/30/2016 |
Portable Slit Lamp Microscope |
SUZHOU KANGJIE MEDICAL INC |
Hong Zhu |
| K162454 |
09/01/2016 |
PicoWay Laser System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K162594 |
09/16/2016 |
Craniomaxillofacial Distraction System (CMFD) |
SYNTHES USA PRODUCTS, LLC |
NICHOLAS FOUNTOULAKIS |
| K162580 |
09/15/2016 |
Guardian Angel GA1000 Digital Vital Sign Monitoring System |
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
ALAN TANG |
| K162636 |
09/21/2016 |
Marco Ultra M3, Marco Ultra M4 |
TAKAGI SEIKO CO.LTD. |
HAGIWARA TORU |
| K162530 |
09/09/2016 |
Multichem IA Plus |
TECHNO-PATH MANUFACTURING |
BERND HASS |
| K162514 |
09/08/2016 |
Multichem A1c |
Technopath Manufacturing |
Bernd Hass |
| K162522 |
09/09/2016 |
UltraCath Continuous Nerve block Catheter |
TELEFLEX MEDICAL , INC. |
James A. Cochie |
| K162710 |
09/28/2016 |
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
TGS Medical Co., Ltd. |
Hua Cao |
| K162564 |
09/14/2016 |
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 |
Tianjin Empecs Medical Device Co.,Ltd. |
Chae Chung Lyuel |
| K162648 |
09/22/2016 |
U-Blade Veress Needle |
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
TAO FAN |
| K162626 |
09/20/2016 |
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE |
TOP QUALITY GLOVE SDN. BHD |
HUE KON FAH |
| K162614 |
09/19/2016 |
Infinix, INFX-8000V, V6.35 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162475 |
09/06/2016 |
mi-eye 2, mi-eye 2 monitor |
Trice Medical |
Tiffini Diage |
| K162619 |
09/20/2016 |
I View and Imagen Sensor |
TRIDENT S.R.L. |
GIORGIO RIZZO |
| K162507 |
09/08/2016 |
Arzzt 3.5 / 4.5 Small & Large Fragments System |
TRUEMED GROUP, LLC |
Jorge Castillo |
| K162656 |
09/23/2016 |
ESU-1 Electrosurgical Generator |
TVA Medical, Inc. |
Katherine Kumar |
| K162661 |
09/26/2016 |
SavDenTM MTA Root Canal Filling Materials |
tYDS Biotech Incorporation |
Liang-Yu Chang |
| K162510 |
09/08/2016 |
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue |
UG GLOBAL RESOURCES SDN. BHD. |
WONG SEE KEONG |
| K162533 |
09/09/2016 |
Kelowna GYN and Crook Prostate Templates |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K162615 |
09/19/2016 |
Mould Applicator Set |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K162472 |
09/06/2016 |
TrueBeam-TrueBeam STx-Edge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K162476 |
09/06/2016 |
Varian High Energy Linear Accelerator |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K162467 |
09/02/2016 |
Twin-Pass Torque |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
| K162660 |
09/26/2016 |
Green Smart (Model: PHT-35LHS) |
VATECH CO., LTD |
Daniel Kim |
| K162765 |
09/30/2016 |
Venus Velocity Diode Laser System |
Venus Concept Ltd. |
Tal Bresler-Stramer |
| K162572 |
09/15/2016 |
NextDent Denture, E-Denture |
VERTEX-DENTAL BV |
O. F. Beckeringh van Loenen |
| K162763 |
09/30/2016 |
Vevazz LED Heat Lamp |
Vevazz, LLC |
Jamie Fettig |
| K162556 |
09/14/2016 |
LIGHTFUSION LED SYSTEM |
VITAGE LED LTD |
SUE D'ARCY |
| K162547 |
09/12/2016 |
Viveve System |
Viveve Inc. |
Jim Talbot |
| K162460 |
09/02/2016 |
WAViÖ Headset and WAViÖ eSocÖ Single Use Electrode Contacts |
WAVI, CO |
ALEXIS VERACRUZ |
| K162663 |
09/26/2016 |
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
| K162532 |
09/09/2016 |
WellDoc BlueStar, WellDoc BlueStar Rx |
WELLDOC, INC |
DANIELLE DORFMAN |
| K162755 |
09/30/2016 |
Picocare |
WON TECH CO., LTD. |
James Hoon Lim |
| K162616 |
09/20/2016 |
Wrist Type Blood Pressure Monitor |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
YanLi Li |
| K162575 |
09/15/2016 |
Z-LINKPC System |
ZAVATION, LLC |
FRANKIE CUMMINS |
| K162489 |
09/07/2016 |
RED Light Device |
Zhongshan Bisen Plastic Electronic Products Co.,Ltd. |
FengPing Li |
