| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K162375 |
12/29/2016 |
Envision 3D: Image Guidance System |
7D SURGICAL INC. |
DANIEL ZISKIND |
| K162005 |
12/08/2016 |
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K162134 |
12/14/2016 |
ENNOVATE Spinal System |
Aesculap Implant Systems, LLC |
Paul Amudala |
| K163000 |
12/23/2016 |
AMPLATZER TorqVue 45x45 Delivery Sheath |
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co |
Mary Johnson |
| DEN150055 |
12/21/2016 |
AeroForm Tissue Expander System |
AIRXPANDERS, INC |
Robin` Bush |
| K152420 |
12/01/2016 |
AK Body Toning Device |
AK BEAUTY ENTERPRISES, LLC |
Robert Applebaum |
| K163266 |
12/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| DEN150022 |
12/20/2016 |
Ultravision Visual Clearing System |
Alesi Surgical Ltd. |
DOMINIC GRIFFITHS |
| K162721 |
12/22/2016 |
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
ALLIQUA BIOMEDICAL, INC. |
KATHY SIMPSON |
| K161299 |
12/23/2016 |
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System |
APEX BIOTECHNOLOGY CORP. |
Hsue-mei Lee |
| K162676 |
12/01/2016 |
Voyant Open Fusion Device |
Applied Medical Resources |
Jessica Cho |
| K160574 |
12/20/2016 |
K3PRO SURGICAL TRAY |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
RICHARD DONACA |
| K160785 |
12/08/2016 |
Worker Guidewire |
ARGON MEDICAL DEVICES, INC. |
SUZANNE CHEANG |
| K162461 |
12/20/2016 |
Endoform Plastics and Reconstructive Matrix |
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) |
Yasmin Rai |
| K160925 |
12/22/2016 |
VPS Rhythm Device with TipTracker Technology |
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) |
KARL J. NITTINGER |
| K161060 |
12/15/2016 |
Arthrex iBalance UKA System Vitamin E Tibial Bearing |
Arthrex, Inc. |
David L Rogers |
| K163264 |
12/21/2016 |
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled |
Avinger, Inc. |
Patty Hevey |
| K160007 |
12/19/2016 |
Paclitaxel Sets |
BAXTER HEALTHCARE CORPORATION |
Tiffany Lin |
| K161837 |
12/16/2016 |
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer |
BECKMAN COULTER INC. |
GERALDINE FUENTESPINA |
| K162081 |
12/19/2016 |
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe |
Becton, Dickinson and Company |
Murtaza Rana |
| K162516 |
12/09/2016 |
BD Pen Needle |
BECTON, DICKINSON AND COMPANY |
MERIAM YOUSSEF |
| K162180 |
12/29/2016 |
Disposable Insulin Syringe |
BERPU MEDICAL TECHNOLOGY CO., LTD |
JUNDONG TAN |
| K161844 |
12/13/2016 |
Matrix Pre-Treatment Controller |
BETTER WATER, LLC. |
MIKE CLINE |
| K162373 |
12/16/2016 |
LC Bead LUMI |
Biocompatibles UK Limited |
Simon Leppard |
| K160854 |
12/19/2016 |
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture |
Biomet Manafacturing Corp. |
Adam Cargill |
| K162974 |
12/09/2016 |
Biomet Microfixation RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K162783 |
12/09/2016 |
EnFocus 2300, EnFocus 4400 |
Bioptigen, Inc. |
Ravi Kommineni |
| K161632 |
12/08/2016 |
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) |
BIOS S.R.L. |
Riccardo Pisati |
| K161704 |
12/01/2016 |
Phasor Drill |
BIOTEX, INC. |
RICHARD WAITE |
| K162192 |
12/15/2016 |
BluePro |
BlueSom |
Erwan Floch |
| K162205 |
12/09/2016 |
Arc EndoCuff and Arc EndoCuff Vision |
BODDINGTONS PLASTICS LTD |
SARAH GIBSON |
| K163174 |
12/14/2016 |
Emerge PTCA Dilatation Catheter |
Boston Scientific Corporation |
Jane Horan |
| K163200 |
12/14/2016 |
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete |
BOSTON SCIENTIFIC CORPORATION |
Ka Zoua Xiong |
| K161215 |
12/21/2016 |
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K160941 |
12/13/2016 |
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter |
Brosmed Medical Co., Ltd. |
Tina Yin |
| K162010 |
12/13/2016 |
HPM-6000U |
BTL Industries, Inc. |
Jan Zarsky |
| K161716 |
12/21/2016 |
TEETHAN 2.0 |
BTS S.P.A. |
VERONICA BARTOLINI |
| K162193 |
12/23/2016 |
XenMatrix AB Surgical Graft |
C.R. Bard |
Tony John |
| K162900 |
12/14/2016 |
PowerMidline Catheter |
C.R. Bard, Inc. |
Casey Coombs |
| K163019 |
12/01/2016 |
CareView 750Cw/750C X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
Xu Wei |
| K163203 |
12/13/2016 |
Carestream DRX-Evolution |
Carestream Health, Inc. |
Carolyn L. Wagner |
| K162568 |
12/15/2016 |
INTRABEAM 600 |
CARL ZEISS MEDITEC AG |
Christian Muenster |
| K161654 |
12/30/2016 |
NuFACE Gel Primer |
Carol Cole Company |
Merle Kovacic |
| K161900 |
12/09/2016 |
HYPERION X5 |
CEFLA SC |
SILVIA SANSAVINI |
| K162352 |
12/22/2016 |
derma+flex QS High Viscosity Tissue Adhesive |
CHEMENCE MEDICAL INC |
Kenneth Broadley |
| K161329 |
12/02/2016 |
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel |
Chrono-log Corp. |
Nicholas J Veriabo |
| K161959 |
12/28/2016 |
ClearView cCAD |
ClearView Diagnostics Inc. |
Christine Podilchuk |
| K160515 |
12/19/2016 |
PS2 Knee System |
CONSENSUS ORTHOPEDICS, INC. |
JUSTIN CREEL |
| K162717 |
12/21/2016 |
Evolution Esophageal Stent System û Partially Covered |
Cook Ireland Ltd. |
Jane Kennedy |
| K163018 |
12/23/2016 |
Zilver 635 Biliary Stent |
Cook Ireland Ltd. |
Nora O'Connor |
| K161755 |
12/14/2016 |
Integrity-SI TM Fusion System |
CoorsTek Medical |
Steve Brown |
| K162127 |
12/05/2016 |
Bencox M Stem Lateralized & Bencox Mirabo Cup System |
CORENTEC CO., LTD |
J. S. DANIEL |
| K160157 |
12/01/2016 |
LOSPA Modular Knee System |
CORENTEC CO., LTD |
Goon Hee Lee |
| K163055 |
12/23/2016 |
Reprocessed Kendall SCD Express Foot Cuff |
COVIDIEN |
Jennifer Sullivan |
| K163105 |
12/06/2016 |
Emprint Ablation System |
COVIDIEN LLC |
PATTI ARNDT |
| K163098 |
12/05/2016 |
Tri-Staple 2.0 Intelligent Cartridge |
Covidien LLC |
REBECCA BREWER |
| K160566 |
12/02/2016 |
Cerasorb Ortho Foam |
CURASAN AG |
Wolf-Dietrich Hubner |
| K162512 |
12/09/2016 |
truSculpt |
CUTERA, INC. |
BRADLEY RENTON |
| K163067 |
12/01/2016 |
CyMedica e-viveÖ System; CY-1000 |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K161566 |
12/21/2016 |
DMS Disposable Subdermal Needle Electrodes |
Daehan Medical Systems Co., Ltd. |
Dong Cheul Kim |
| K161244 |
12/07/2016 |
s-Clean OneQ-SL Narrow Implant System |
Dentis Co., Ltd. |
Sun Chul Shin |
| K161713 |
12/16/2016 |
Dentium CAD/CAM Abutments |
Dentium Co., Ltd |
Sangpil Yoon |
| K162227 |
12/10/2016 |
STA« - Liatest« D-Di |
Diagnostica Stago |
Arnaud Berthier |
| K162421 |
12/21/2016 |
IntelliCartTM System |
DORNOCH MEDICAL SYSTEMS |
LARRY SMITH |
| K162552 |
12/02/2016 |
EVS 3643, EVS 3643G |
DRTECH Corporation |
Choul-Woo Shin |
| K162555 |
12/21/2016 |
EVS 4343, EVS 4343G |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K160981 |
12/22/2016 |
Patient Monitor |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K160982 |
12/22/2016 |
SphynxÖ |
Eden Spine LLC |
Guillaume Viallaneix |
| K163335 |
12/15/2016 |
6MP Color LCD Monitor, RadiForce RX660, RX660-AR |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K160949 |
12/22/2016 |
Go Dose System |
ELI LILLY AND COMPANY |
SUMITRA M GHATE |
| K162140 |
12/01/2016 |
RemLogic |
EMBLA SYSTEMS |
SHANE T. SAWALL |
| K161906 |
12/01/2016 |
SCIg60 Infuser |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K162578 |
12/16/2016 |
Zerona Z6 OTC |
ERCHONIA CORPORATION |
STEVEN SHANKS |
| K163539 |
12/23/2016 |
Ez3D-i / E3 |
EWOO SOFT Co., Ltd. |
Young Seok Kim |
| K162972 |
12/02/2016 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging |
Karina Torres |
| K161550 |
12/22/2016 |
DynaMesh-VENTRAL |
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT |
STEFAN SCHNEEMELCHER |
| K162176 |
12/01/2016 |
Fiagon Navigation System |
Fiagon GmbH |
Dirk Mucha |
| K160707 |
12/17/2016 |
CustomizedBone Service |
FIN-CERAMICA FAENZA SPA |
Monticelli Marina |
| DEN160020 |
12/21/2016 |
CipherOx CRI Tablet |
Flashback Technologies, Inc. |
Gordon Van Dusen |
| K163053 |
12/01/2016 |
Lumipulse G E2-III Calibrators |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K161682 |
12/02/2016 |
GE Lunar DXA Bone Densitometers with enCORE version 17 |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC |
Nicole Landreville |
| K163213 |
12/16/2016 |
Revolution CT |
GE Medical Systems, L.L.C. |
Helen Peng |
| K160972 |
12/28/2016 |
Gexfix External Fixation |
Gexfix International Corp. |
Maurizio Longo |
| K162442 |
12/12/2016 |
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
Martin D. Paugh |
| K162747 |
12/08/2016 |
Proture Double Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Jun Deng |
| K160306 |
12/13/2016 |
Cloud Smart Thermometer |
GUANGZHOU BOSMA TECHNOLOGY CO LTD |
Guoxing Dai |
| K163373 |
12/12/2016 |
PK AIM |
Gyrus ACMI Inc. |
Graham A.L. Baillie |
| K162048 |
12/05/2016 |
EZstim*III Peripheral Nerve Stimulator/Nerve Locator |
HALYARD HEALTH - IRVINE |
Maria Pronina |
| K163236 |
12/16/2016 |
COOLIEF Cooled Radiofrequency Kit |
Halyard Health, Inc. |
Mary Ann B Kinard |
| K160928 |
12/20/2016 |
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| K162902 |
12/15/2016 |
ARIETTA Prologue Diagnostic Ultrasound system and Transducers |
HITACHI, LTD. |
ANGELA VAN ARSDALE |
| K160492 |
12/06/2016 |
Hospira Sapphire Sets |
Hospira, Inc |
David Blonski |
| K161237 |
12/16/2016 |
HyperView Hyperspectral Tissue Oxygenation Measurement System |
HYPERMED IMAGING, INC. |
Carlyn Reynolds |
| K160742 |
12/16/2016 |
NoCoding1 Plus Blood Glucose Monitoring System |
i-SENS, INC. |
Joon Ho Jung |
| K161947 |
12/16/2016 |
Chagas Detect Plus Rapid Test |
INBIOS INTERNATIONAL, INC. |
ESTELA RAYCHAUDHURI |
| K163190 |
12/12/2016 |
InMode RF System |
INMODE MD LTD. |
Amit Goren |
| K162344 |
12/20/2016 |
INNOLUX RIC |
INNOLUX CORPORATION |
Andy Kuo |
| K161827 |
12/08/2016 |
Reprocessed Response Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
SHARON HIGGINS |
| K161769 |
12/06/2016 |
Reprocessed Supreme Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
Sharon Higgins |
| K162251 |
12/21/2016 |
Reprocessed Viking Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
Sharon Higgins |
| K160415 |
12/14/2016 |
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) |
Instrumentation Laboratory Co. |
Carol Marble |
| K160412 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) |
Instrumentation Laboratory Co. |
Carol Marble |
| K160402 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) |
Instrumentation Laboratory Co. |
Carol Murble |
| K160225 |
12/14/2016 |
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K160811 |
12/06/2016 |
CRW STEREOTACTIC SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
TIMOTHY CONNORS |
| K162696 |
12/28/2016 |
Kuschall Advance Manual Wheelchair |
INVACARE CORPORATION |
ELIJAH N. WREH |
| K162686 |
12/28/2016 |
Kuschall Champion Manual Wheelchair |
Invacare Corporation |
Elijah N. Wreh |
| K162692 |
12/28/2016 |
Kuschall K-Series Attract Manual Wheelchair |
INVACARE CORPORATION |
Elijah N. Wreh |
| K143369 |
12/15/2016 |
MRidium 3860+ MRI infusion Pump/ Monitoring System |
IRADIMED CORPORATION |
FRANCIS X CASEY |
| K161730 |
12/08/2016 |
Wireless Digital Flat Panel Detector |
IRAY TECHNOLOGY (SHANGHAI) LTD. |
WEI PAN |
| K160798 |
12/15/2016 |
IPS e.max« Press Abutment Solutions for Viteo Base Ti |
IVOCLAR VIVADENT AG |
Sandra Cakebread |
| K162478 |
12/22/2016 |
ivWatch |
ivWatch, LLC |
Jaclyn Lautz |
| K163308 |
12/27/2016 |
SMARTO |
JEIL MEDICAL CORPORATION |
JAEHAN PARK |
| K162600 |
12/09/2016 |
Jewel Precision Reusable Rigid Sterilization Container System |
JEWEL PRECISION SHEET METAL & MACHINE, INC. |
GARY SCHNEBERGER |
| K161488 |
12/08/2016 |
ESTETICA Dental Treatment Unit and Accessories |
KALTENBACH & VOIGT GMBH |
STEFAN TRAMPLER |
| K160487 |
12/09/2016 |
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System |
KCI USA, Inc. |
Kristen Weniger Hopewell |
| K162436 |
12/21/2016 |
EndoVac Pure |
Kerr Corporation |
Mohammad Saad Ansari |
| K161470 |
12/01/2016 |
Internal Distraction - Sterile |
KLS MARTIN LP |
JENNIFER DAMATO |
| K161259 |
12/19/2016 |
KLS Martin Cannulated Headless Screws |
KLS MARTIN LP |
JENNIFER DAMATO |
| K161127 |
12/22/2016 |
The Small PLATEAU (PLATEAU-C) Spacer System |
LIFE SPINE INC. |
RANDY LEWIS |
| K162854 |
12/19/2016 |
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml |
Liofilchem s.r.l. |
Fabio Brocco |
| K162428 |
12/06/2016 |
DiLumen Endolumenal Interventional Platform |
Lumendi, LLC |
Dennis Daniels |
| K162772 |
12/23/2016 |
ARIES GBS Assay |
LUMINEX CORPORATION |
CHRISTIE HUGHES |
| K163347 |
12/15/2016 |
xTAG Cystic Fibrosis 39 Kit v2 |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K163336 |
12/15/2016 |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR |
Luminex Molecular Diagnostics, Inc. |
Jennifer Grimes |
| K160695 |
12/06/2016 |
Talymed Suspension |
Marine Polymer Technologies, Inc. |
Sergio Finkielsztein |
| K162675 |
12/28/2016 |
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K163311 |
12/21/2016 |
GMK Revision Femoral Distal Augmentation |
Medacta International SA |
Stefano Baj |
| K161128 |
12/01/2016 |
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply |
Medela AG |
Markus Butler |
| K152327 |
12/01/2016 |
EasyLyte Na/K/Cl/Ca Analyzer |
Medica Corporation |
Photios Makris |
| K161916 |
12/21/2016 |
TelePatch Cardiac Monitor |
MEDICOMP, INC. |
Sean Marcus |
| K162194 |
12/08/2016 |
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System |
MEDICREA INTERNATIONAL S.A |
DAVID RYAN |
| K162128 |
12/21/2016 |
Scope Buddy Plus Endoscope Flushing Aid |
MEDIVATORS INC. |
Kristin Bergeson Padilla |
| K162829 |
12/09/2016 |
Medline UNITE« Ankle Fracture Plating System |
MEDLINE, INDUSTRIES, INC. |
Jennifer Mason |
| K163106 |
12/01/2016 |
CODMAN Integrated Bipolar Cord and Tubing Set |
Medos International SARL |
Megan Palumbo |
| K162247 |
12/15/2016 |
PERMATAPE |
MEDOS INTERNATIONAL SARL |
TATYANA KORSUNSKY |
| K160879 |
12/20/2016 |
CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems |
Medos International Sαrl |
KIRSTEN LEMULLER |
| K162327 |
12/12/2016 |
COUGAR« LS Lateral Cage System and COUGAR« System |
Medos International, Sarl |
Eric Zhu |
| K162912 |
12/08/2016 |
VIPER PRIMEÖ additions to the VIPER« System |
MEDOS INTERNATIONAL, SARL |
Karen Sylvia |
| K161400 |
12/08/2016 |
ImagingRing System |
MEDPHOTON GMBH |
Daniel Schaffarzick |
| K163158 |
12/02/2016 |
MEDSYNAPSE Zero Footprint Viewer |
MEDSYNAPTIC PRIVATE LTD. |
Ashish Dhawad |
| K162604 |
12/30/2016 |
Cranial Reducing Tubes |
MEDTRONIC NAVIGATION, INC. |
Christopher Perman |
| K163301 |
12/20/2016 |
CD HORIZON« Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Justin O'Connor |
| K162680 |
12/14/2016 |
SOVEREIGN« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KANESHA HINES |
| K162896 |
12/06/2016 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface |
MEDTRONIC, INC. |
RENEE CVEYKUS |
| K160771 |
12/19/2016 |
Destiknee Total Knee System |
MERIL HEALTHCARE PRIVATE LIMITED |
Umesh Sharma |
| K161728 |
12/05/2016 |
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 |
MICROFILE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K161639 |
12/22/2016 |
Y-MIC |
MICRON CORPORATION |
Takashi Terui |
| K163154 |
12/09/2016 |
Traxcess 7 Mini XSoft Guidewire |
MicroVention, Inc. |
Sapna Singh |
| K162630 |
12/20/2016 |
CP Relief Wand-OTC |
Mid-America Medical Innovations LLC |
Norm Schroeder |
| K161871 |
12/19/2016 |
EVA (Enhanced Visual Assessment) System |
MobileODT Ltd. |
Jen Acobas |
| K153426 |
12/21/2016 |
Ox-Imager CS |
MODULATED IMAGING, INC. |
DAVID CUCCIA |
| K161425 |
12/05/2016 |
APEX Manual Wheelchair |
Motion Composites |
Stephane Le Beau |
| K160745 |
12/12/2016 |
neoBLUE compact LED Phototherapy System |
NATUS MEDICAL INCORPORATED |
THERESE LEGGIERE |
| K163163 |
12/14/2016 |
XLTEK EMU40EX EEG Headbox |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K161399 |
12/22/2016 |
Neocis Guidance System |
Neocis Inc. |
Alon Mozes |
| K161467 |
12/22/2016 |
HydraGuard 10 UltraFilter |
NEPHROS INC. |
JAMES SUMMERTON |
| K152664 |
12/02/2016 |
TAV System |
New Aera, Inc. |
ERIC JOHANSSON |
| K161307 |
12/21/2016 |
NICO Myriad |
NICO CORPORATION |
SEAN SPENCE |
| K162869 |
12/09/2016 |
Contact Lens Case |
Ningbo Yinzhou Zonghai Artware Co., Ltd. |
Weng Changhai |
| K160231 |
12/23/2016 |
Model X-100C CO-MetÖ Oximetry System |
NONIN MEDICAL, INC. |
KIM E. AVES |
| K162371 |
12/15/2016 |
Pulsaderm ACE-All Blue |
Nutra Luxe MD, LLC |
Gloria Avendano |
| K163180 |
12/29/2016 |
Hubble II |
Orbbo Surgical, LLC |
Eric Garofano |
| K152813 |
12/02/2016 |
FS-500DDR Medical Radiographic X-Ray System |
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. |
JU PENG |
| K162020 |
12/16/2016 |
VITROS Chemistry Products Cl- Slides |
Ortho Clinical Diagnostics |
Marlene Hanna |
| K162638 |
12/16/2016 |
CETRA Anterior Cervical Plate System |
Orthofix Inc. |
Jacki Koch |
| K162446 |
12/22/2016 |
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System |
ORTHOFIX INC. |
JACKI KOCH |
| K153015 |
12/05/2016 |
Transfer & Angled Abutment |
Osstem Implant Co., Ltd |
Hee Kwon |
| K161197 |
12/21/2016 |
Orthodontic Screw |
OSSTEM IMPLANT CO., LTD. |
NA HEEKWON |
| K162233 |
12/23/2016 |
Kurin Blood Culture Collection Set |
Pathway LLC |
Emily Davis |
| K161739 |
12/19/2016 |
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
PEGAVISION CORPORATION |
Judith Hou |
| K150960 |
12/01/2016 |
WoundPro Negative Pressure Wound Therapy System |
PENSAR MEDICAL LLC |
BRIAN GUTHRIE |
| K161800 |
12/06/2016 |
OnSite-IV |
PHARMC, LLC |
CHRIS TICE |
| K162955 |
12/19/2016 |
Multi-Modality Tumor Tracking (MMTT) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K162940 |
12/30/2016 |
MultiBand SENSE |
Philips Medical Systems Nederland B.V. |
Jan Van de Kerkhof |
| K162859 |
12/02/2016 |
Allura Xper FD series and Allura Xper OR Table series |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| K162418 |
12/02/2016 |
Pioneer Plus Catheter |
PHILIPS VOLCANO |
MARY STANNERS |
| K162376 |
12/08/2016 |
CAAS MR 4D Flow |
PIE MEDICAL IMAGING B.V. |
ANNEMIEK BOUTS |
| K151545 |
12/22/2016 |
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K162282 |
12/22/2016 |
CardioChek Plus Test System, CardioChek Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Margo Enright |
| K161809 |
12/06/2016 |
ShurFit CpTi-HA ACIF Interbody Fusion System |
Precision Spine, Inc. |
Michael C. Dawson |
| DEN150038 |
12/16/2016 |
CleanCisionTM Wound Retraction and Protection System |
Prescient Surgical |
Lisa Ruehlow |
| K162246 |
12/08/2016 |
ProNova SC360 Proton Therapy System |
ProNova Solutions, LLC |
ADAM KUHN |
| K163068 |
12/22/2016 |
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent |
Q UROLOGICAL CORPORATION |
SCOTT EPSTEIN |
| K162623 |
12/09/2016 |
16ch T/R Hand Wrist Coil |
QUALITY ELECTRODYNAMICS, LLC |
KATHLEEN ARAS |
| K163222 |
12/05/2016 |
Discovery Pico Family |
Quanta System Spa |
Francesco Dell'Antonio |
| K163009 |
12/01/2016 |
Litho |
Quanta System SpA |
FRANCESCO DELL' ANTONIO |
| K162304 |
12/06/2016 |
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets |
QUEST MEDICAL, INC. |
Amy Clendening-Wheeler |
| K162468 |
12/01/2016 |
ClearCheck |
RADFORMATION |
KURT SYSOCK |
| K161613 |
12/28/2016 |
Hang&Go PAC |
RanD S.r.l. |
Simone Ceretti |
| K162066 |
12/02/2016 |
Reliance Spinal Screw System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K162051 |
12/14/2016 |
Cryotec |
REPROLIFE INC. |
KOICHI TAKEDA |
| K160836 |
12/15/2016 |
Menai System |
ResMed Ltd |
Greg Dockar |
| K160614 |
12/16/2016 |
Xcite Clinical Station |
RESTORATIVE THERAPIES INC. |
Andrew Barriskill |
| K162677 |
12/21/2016 |
L- OVC |
Rhondium, Ltd |
Greer Fricker |
| K161734 |
12/09/2016 |
Vanguard Dental Unit |
RITTER CONCEPT GMBH |
WEN FANG |
| K160475 |
12/14/2016 |
Ritter Dental Implant System |
Ritter Implants GmbH & Co. KG |
Werner Schmitz |
| DEN150057 |
12/19/2016 |
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 |
ROCHE DIAGNOSTICS |
Edie Eads |
| K160915 |
12/14/2016 |
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker |
ROCHE DIAGNOSTICS |
Adam Clark |
| K160571 |
12/19/2016 |
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay |
Roche Diagnostics Operations (RDO) |
David Tribbett |
| K162531 |
12/29/2016 |
STERISPINE CC |
SAFE ORTHOPAEDICS |
SOPHIE REHAULT |
| K163206 |
12/15/2016 |
SMD-Sr90-DA Radionuclide Brachytherapy Source |
Salutaris Medical Devices, Inc. |
Laurence Marsteller |
| K163115 |
12/07/2016 |
GC70 |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K162351 |
12/01/2016 |
SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device |
SEASPINE ORTHOPEDICS CORPORATION |
Gina Flores |
| K161928 |
12/21/2016 |
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL |
Sebia |
Karen Anderson |
| K163078 |
12/08/2016 |
DC-UIBC-CAL |
SEKISUI DIAGNOSTICS P.E.I. INC. |
PENNY WHITE |
| K162845 |
12/15/2016 |
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
ZHAI PEI |
| K160969 |
12/12/2016 |
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler |
SHINEMED LLC |
ROGELIO A. INSIGNARES |
| K163306 |
12/22/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
Plessy Paul |
| K162420 |
12/12/2016 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
PETRA DISSMANN |
| K162688 |
12/26/2016 |
Sysmex CS-2100i |
Siemens Healthcare Diagnostics Products GmbH |
Donna Noeh |
| K162302 |
12/16/2016 |
Somatom Confidence « RT Pro |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K161233 |
12/14/2016 |
OXINIUM DH Fermoral Heads |
SMITH & NEPHEW, INC. |
MIKE SCOTT |
| K163086 |
12/21/2016 |
VLP MINI-MOD 2.0mm Column Plates |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K163034 |
12/07/2016 |
SUTUREFIX Curved Suture Anchor |
Smith and Nephew, Inc. |
Anne-Marie Keefe |
| K160946 |
12/05/2016 |
4.0 and 6.5 Cancellous Bone Screw and Washer |
SMV SCIENTIFIC |
Nephi Zufelt |
| K160942 |
12/21/2016 |
Sonablate |
SonaCare Medical, LLC |
DAVID M. HERNON |
| K163063 |
12/12/2016 |
UC-5000 Mobile X-Ray |
SOURCE-RAY, INC. |
RAY MANEZ |
| K161548 |
12/01/2016 |
Osseointegrated Fixtures |
SOUTHERN IMPLANTS (PTY) LTD. |
LAURANDA BREYTENBACH |
| K160335 |
12/13/2016 |
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D |
St. Jude Medical |
Tamara Stanczak |
| K160218 |
12/13/2016 |
AutoMark Module |
St. Jude Medical |
Melissa Frank |
| K160210 |
12/13/2016 |
EnSite Precision Cardiac Mapping System v2.0 |
ST. JUDE MEDICAL |
Marlene Peterson |
| K162643 |
12/13/2016 |
MediGuide Technology System |
ST. JUDE MEDICAL |
MARLENE PETERSON |
| K152009 |
12/05/2016 |
DENSEEMAMMO v1.0 |
STATLIFE |
STEPHANE RAGUSA |
| DEN160005 |
12/19/2016 |
Hem-Avert Perianal Stabilizer |
STETRIX, INC. |
MARK BUCHANAN |
| K162161 |
12/16/2016 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K162702 |
12/30/2016 |
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table |
STL International, Inc. |
Rylie Teeter Leier |
| K160585 |
12/22/2016 |
XN CAL |
Streck |
Deborah Kipp |
| K160590 |
12/22/2016 |
XN CHECK |
STRECK |
DEBORAH KIPP |
| K160588 |
12/22/2016 |
XN CHECK BF |
STRECK |
DEBORAH KIPP |
| K160586 |
12/22/2016 |
XN-L CHECK |
STRECK |
DEBORAH KIPP |
| K161821 |
12/08/2016 |
Stryker Universal Mesh |
Stryker |
Jonathan Schell |
| K152266 |
12/02/2016 |
Altrix Precision Temperature Management System |
STRYKER MEDICAL |
BRIAN ORWAT |
| K163028 |
12/28/2016 |
Medline ReNewal Reprocessed Stryker External Fixation Devices |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K162004 |
12/05/2016 |
PREMIUM Implant Systems SHELTA Implant Systems |
SWEDEN & MARTINA S.p.A. |
Alessia Pezzato |
| K160538 |
12/22/2016 |
Sysmex XN-L Automated Hematology Analyzer |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
| K162022 |
12/22/2016 |
Collagentex Rx-1 |
Tanses Technologies inc. |
Kirk Kiremitci |
| K160309 |
12/22/2016 |
Neurosoft TMS |
TeleEMG, LLC |
Joe F Jabre |
| K160070 |
12/07/2016 |
Rheumatoid Factor (RF) Kit for use on SPAPLUS |
THE BINDING SITE GROUP, LTD. |
Jon Lauder |
| K162003 |
12/21/2016 |
IMSE Cervical Cage |
The Institute of Musculoskeletal Science & Education |
Ed McShane |
| K160222 |
12/07/2016 |
OIC Cervical PEEK Spacer |
THE ORTHOPAEDIC IMPLANT COMPANY |
DOUGLAS FULTON |
| K162648 |
12/12/2016 |
U-Blade Veress Needle |
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
TAO FAN |
| K161972 |
12/09/2016 |
Slit Lamp SL-D301 |
TOPCON CORPORATION |
MICHAEL GUSEL |
| K161789 |
12/27/2016 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER SAS |
AYMEN AZAIEZ |
| K152778 |
12/21/2016 |
TRACOE Cuff Pressure Monitor |
TRACOE MEDICAL GMBH |
STEPHAN KOHLER |
| K161032 |
12/22/2016 |
neon3Ö universal OCT spinal stabilization |
ULRICH GMBH & CO. KG |
Christoph Ulrich |
| K161723 |
12/21/2016 |
ulrich Transfer Set |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K162476 |
12/12/2016 |
Varian High Energy Linear Accelerator |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K161702 |
12/06/2016 |
Endura guidewire |
Vascular Solutions, Inc. |
BEKA VITE |
| K160377 |
12/02/2016 |
V-varnish Premium |
Vericom Co., Ltd. |
Myung-Hwan Oh |
| K161757 |
12/05/2016 |
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads |
VICTOR MEDICAL INSTRUMENTS CO.,LTD. |
Yunhuo Chen |
| K161453 |
12/05/2016 |
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
| K162343 |
12/14/2016 |
Westmed Gas Sampling Cannula with O2 delivery |
WESTMED, INC. |
DIANA UPP |
| K160849 |
12/15/2016 |
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
CHIH-WEN TSAI |
| K161322 |
12/07/2016 |
CT CoPilot |
ZEPMED, LLC. |
Douglas J. Bates |
| K160852 |
12/15/2016 |
Zia |
Zetta Medical Technologies, LLC. |
Main M. Ghazal |
| K162259 |
12/21/2016 |
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
ZIBO DAIYANG PLASTIC COMPANY |
YANG YAN HONG |
| K161390 |
12/19/2016 |
Vinyl Exam Gloves, Powder Free, Clear |
Zibo Hongchin Plastic and Rubber Co., Ltd |
James Ren |
| K162114 |
12/12/2016 |
Photon, Photon Plus |
Zolar Technology & MFG Co. Inc. |
Paul Atkins |
