FDA 510(k) Decisions During December, 2016  

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
K160879 12/20/2016 CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems Medos International S?rl KIRSTEN LEMULLER
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
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact