FDA 510(k) Decisions During September, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K153387 09/08/2016 Luna CPAP and Auto CPAP System 3B MEDICAL, INC. ALEX LUCIO
K151285 09/23/2016 VSP Cranial System 3D Systems, Inc. Kim Torluemke
K153705 09/02/2016 PROcedure Rehearsal Studio 3DSYSTEMS, SIMBIONIX PRODUCTS KIM TORLUEMKE
K161922 09/01/2016 XP202 3M DEUTSCHLAND GMBH RUEDIGER FRANKE
K151455 09/06/2016 3Shape Abutment Designer Software 3Shape A/S Hanne Nielsen
DEN150056 09/16/2016 Acclarent Aera Eustachian Tube Balloon Dilation System ACCLARENT, INC. JAMES PATRICK GARVEY
K153207 09/07/2016 Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC GREGORY KOWALCZYK
K160903 09/26/2016 STERRAD 100NX Sterilizer with ALLClearTM Technology ADVANCED STERILIZATION PRODUCTS JAMIE BYUN
K160818 09/27/2016 STERRAD« NX Sterilizer with ALLClearÖ Technology ADVANCED STERILIZATION PRODUCTS Jamie Byun
K161994 09/22/2016 Aerin Medical Stylus Aerin Medical, Inc. Scott Wolf
K162228 09/09/2016 TorqVue Low Profile Delivery Catheter AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR Mary Johnson
K161368 09/22/2016 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa HealthCare N.V. Koen Vervoort
K160221 09/12/2016 Implance Dental Implant System, Implance Dental Abutment System AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. Gorkem Serce
K160862 09/19/2016 AirStrip RPM AirStrip Technologies, Inc. Andy Miller
K161984 09/27/2016 Interlocked Circular Small Field Collimators, Elekta Integrated AKTINA MEDICAL CORPORATION TONY SPACCAROTELLA
K162013 09/15/2016 Eusol-C AL.CHI.MI.A. S.r.l. Mauro Beccaro
K161625 09/19/2016 PixelShine ALGOMEDICA Jagdish Vij
K160958 09/08/2016 Battalion Universal Spacer System ALPHATEC SPINE MARY FUNK
K161439 09/21/2016 E-CUBE 11 ALPINION MEDICAL SYSTEMS CO., LTD. DONGHWAN KIM
K160784 09/14/2016 CAM Titanium Blanks ALTATEC GMBH COLLEEN BOSWELL
K161656 09/01/2016 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor AMBU A/S CAMILLA WISMAR
K151839 09/09/2016 AMC Health VitalCaregiving System AMC Health Jonathan Shankman
K161658 09/14/2016 Anexa Wound Flush, Sterile Water & Sterile Normal Saline ANEXA BIOMEDICAL, INC. LENNY BUDLOO
K161765 09/06/2016 CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, JULIE LAWSON
K161581 09/09/2016 Arthrex Synergy RF System ARTHREX, INC. William Heard
K162126 09/29/2016 Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthroCare Corporation Ashley M. Johnson
K160582 09/02/2016 WiCap Athena GTX Sean Mahoney
K161239 09/01/2016 MTA2.2 MATERIAL AVALON BIOMED INC. CAROLYN PRIMUS
K161878 09/26/2016 PORTAGE System Baylis Medical Company Inc. Meghal Khakhar
K153542 09/07/2016 Pelican Sling Retractor Beacon Surgical, Inc. Allan Alward
K160657 09/23/2016 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube BECTON, DICKINSON AND COMPANY Branden Reid
K151589 09/06/2016 BD MAX CT/GC/TV, BD MAX INSTRUMENT BECTON, DICKINSON, AND COMPANY KATIE COYLE
K161166 09/08/2016 StageOne Select Cement Spacer Molds for Temporary Hip Replacement BIOMET, INC. Carmen Albany
K161051 09/09/2016 All-Bond Universal w/BAC (not finalized) Bisco, Inc. Ryan Hobson
K160274 09/01/2016 Hi bebe plus BISTOS CO., LTD. Jenny Cho
K161568 09/16/2016 Bone Solutions Mixing and Delivery System BONE SOLUTIONS, INC. DREW DIAZ
K161068 09/22/2016 Ahead 300 BRAINSCOPE COMPANY INC Michael Singer
K161551 09/13/2016 TR-100 BTL INDUSTRIES, INC. Jan Zarsky
K161424 09/29/2016 Phasix Mesh C.R. BARD INC. JANNA BABSON
K162377 09/22/2016 PowerGlide Pro Midline Catheter C.R. BARD, INC. JACOB LEE
K161151 09/21/2016 Spinal fixation system CANWELL MEDICAL CO., LTD. CHEN HUI
K160413 09/21/2016 Sterling 5W Diode Laser CAO Group, Inc. Robert K Larsen
K153654 09/16/2016 Sentry WEB SmartInterp CareFusion Germany 234 GmbH Elmar Niedermeyer
K162178 09/01/2016 CareView 1500P X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. XU WEI
K160867 09/12/2016 Pavati Z40.2 Zirconia CCRI, INC. ROBIN CARDEN
K160957 09/27/2016 CDB Self Ligating Bracket 8F CDB CORPORATION YANNIRE THOMPSON
K161446 09/27/2016 Biopor Porous Polyethylene Implants Ceremed , Inc. Chelsea Mitchell
K162172 09/14/2016 EBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. QIFEI LIU
K161915 09/09/2016 Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO.,INC. Lisa Burns
K161406 09/08/2016 Navident ClaroNav Inc. Doron Dekel
K162224 09/22/2016 ArtPix Mobile EZ2GO CMT MEDICAL TECHNOLOGIES, LTD. LILIA SCHLOSBERG
K161672 09/29/2016 SpeediCath Flex Coude Coloplast Corp. Rebecca S. Roberts
DEN150049 09/02/2016 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm CONCENTRIC MEDICAL, INC. JIM LEATHLEY
K153599 09/01/2016 Concert Medical Hands-Free Syringe (HFS) Concert Medical, LLC Timothy S Powers
K161344 09/20/2016 GentleCath Glide Intermittent Catheter CONVATEC LIMITED ELINOR JONES
K160136 09/28/2016 Flowable Wound Matrix COOK BIOTECH INCORPORATED PERRY W. GUINN
K161002 09/28/2016 Aprima Smartesis Centesis Pump COOK INCORPORATED ERUM B. NASIR
K153761 09/22/2016 Emergency Transtracheal Airway Catheter COOK INCORPORATED KOTEI AOKI
K160593 09/02/2016 Indy OTW Vascular Retriever COOK INCORPORATED Chad Schulenburg
K160423 09/02/2016 Perineologic Access Needle Corbin Clinical Resources, LLC Kenneth K. Kleinhenz
K162110 09/15/2016 CORGRIP NG/NI Tube Retention System CORPAK MedSystems, Inc. a Division of Haylard Health Stephanie Wasielewski
K162047 09/15/2016 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated COVIDIEN CELSO DURAN
K161804 09/16/2016 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider COVIDIEN DAWN D. TINDALL
K161963 09/01/2016 Monoject Enteral Syringe with ENFit Connector COVIDIEN SONA MANICKAM
K161347 09/07/2016 Signia sterilization tray COVIDIEN KATHERINE Y. CHOI
K151090 09/21/2016 CPL Insulin Pen Needle CPL CO., LTD. CHOI KYOUNG SOO
K160436 09/29/2016 CreoDent Solidex Custom Abutment CreoDent Prosthetics, Ltd. Calvin Shim
K160410 09/29/2016 WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head Dental Savings Club Chadi Saade
K160828 09/15/2016 Dentium Implantium & SuperLine Prosthetics DENTIUM CO., LTD. Sangpil Yoon
K160207 09/21/2016 ATLANTIS ISUS Implant Suprastructures DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K160825 09/27/2016 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA Helen Lewis
K162107 09/27/2016 TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA HELEN LEWIS
K161721 09/20/2016 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set Diazyme Laboratories Abhijit Datta
K160443 09/30/2016 TempoCem Clear DMG USA, INC. Gordon Craig
K161187 09/09/2016 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs ECO MEDI GLOVE SDN BHD Suresh Kumar
K161320 09/01/2016 EMG Pink Nitrile Examination Glove Powder Free ECO MEDI GLOVE SDN. BHD. Suresh Kumar
K162184 09/02/2016 Edwards eSheath Introducer Set Edward Lifesciences Yi Gao
K162497 09/19/2016 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR EIZO CORPORATION Hiroaki Hashimoto
K153644 09/07/2016 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II ELITechGroup Valerie Gourdon
K161162 09/16/2016 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra ELLIPSE A/S OLE KOFOD
K161945 09/23/2016 EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) ENCORE MEDICAL, L.P. TEFFANY HUTTO
K160945 09/26/2016 Endophys Blood Pressure Monitor ENDOPHYS HOLDINGS, LLC Rebecca K. Pine
K161067 09/15/2016 Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö ENGINEERED TISSUE SOLUTIONS, LLC Mark Borden
K161168 09/02/2016 MyLabSix Ultrasound System Esaote Europe B.V. Bert Vorstenbosch
K160554 09/09/2016 Enseal X1 Large Jaw Tissue Sealer ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K161004 09/09/2016 Self-retaining Retractor FETZER MEDICAL GMBH & CO.KG Harald Jung
K161940 09/18/2016 Guidewire 0.6 Single Use FIGON GMBH Dirk Mucha
K160531 09/01/2016 Noiselezz FIRMA INGEMARSSON Natashia Ingemarsson-Matzen
K153505 09/20/2016 F&P Eson 2 Nasal Mask FISHER & PAYKEL HEALTHCARE LIMITED SUE CHO
K160735 09/16/2016 CATSmart FRESENIUS KABI AG Barry G. Hicks
K162288 09/08/2016 SonoSite iViz Ultrasound System FUJIFILM SONOSITE, INC. Patricia Liau
K153130 09/13/2016 Initial LiSi Block GC AMERICA INC. MARK HEISS
K162012 09/15/2016 CARESCAPE Central Station V2 GE HEALTHCARE ROBERT CASARSA
K161567 09/01/2016 SIGNA Voyager GE HEALTHCARE Glen Sabin
K162059 09/29/2016 EZEE RETRIEVAL GENICON, INC KATLYN KACHMAN
K153676 09/14/2016 OSTEON III GENOSS CO., LTD. EUNSANG LEE
K161717 09/20/2016 Personal Kinetigraph (PKG) System GKC MANUFACTURING PTY LTD. BRENDAN FAFIANI
K142846 09/08/2016 BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. EBLESS V BAEZ ALERS
K161591 09/21/2016 QUARTEXÖ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments GLOBUS MEDICAL INC. Kelly J. Baker
K161379 09/29/2016 ELSA Spacers GLOBUS MEDICAL, INC. KELLY J. BAKER
K161707 09/01/2016 Madsen Zodiac GN OTOMETRICS Asif Muhammad
K153580 09/07/2016 Central Monitoring System GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jin Liang
K161825 09/26/2016 PK AIM GYRUS ACMI INC. GRAHAM A.L. BAILLIE
K160709 09/06/2016 HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves Halyard Health Gwendolyn George
K161232 09/30/2016 ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit HALYARD HEALTH GWENDOLYN GEORGE
K153046 09/06/2016 HAMILTON-MR1 HAMILTON MEDICAL AG KATRIN VOGT
K160919 09/20/2016 Hansen Medical Magellan Robotic Catheter 9Fr HANSEN MEDICAL, INC. MARYSA LOUSTALOT
K160255 09/15/2016 HBOTC Muscle and Nerve Stimulator HB MEDICAL, INC. RYAN HEANEY
K160140 09/30/2016 DENTRIa series HDX WILL CORP. Hyung-suk Oh
K162338 09/21/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K162079 09/16/2016 TRILLIUM Oval Head Coil 32 HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K152405 09/01/2016 IBL 5000 Tanning Booth IBL ACQUISITIONS LLC MICHAEL GILLEY
K160023 09/30/2016 Electronic Stethoscope DS301 IMEDIPLUS INC. SHIRLEY LAI
K153609 09/08/2016 RTS Flexible 1 MPJ Implant w/Grommets In2BonesUSA, LLC Joe Clift
K160365 09/28/2016 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System Infopia Co., Ltd. NA YUN KIM
K161262 09/19/2016 Super Distal Access (SDA) INNEUROCO, INC Marc Litzenberg
K162143 09/23/2016 FixxSure« X-Link INNOVASIS, INC. MARSHALL MCCARTY
K161464 09/30/2016 Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC Rafal Chudzik
K160262 09/16/2016 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG Christopher Klaczyk
K161818 09/14/2016 GEM Premier 3000 Instrumentation Laboratory Co. Nikita Malladi
K161992 09/22/2016 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems INTEGRA LIFESCIENCES CORPORATION JENNIFER SIEGEL
K162411 09/21/2016 da Vinci Xi 12 û 8 mm Reducer Intuitive Surgical, Inc. Vishal Kanani
K160630 09/27/2016 Invacare Platinum Mobile Oxygen Concentrator INVACARE CORPORATION ELIJAH N. WREH
K162177 09/14/2016 dS FootAnkle I6CH 1.5T Coil Invivo Corporation Ken Revennaugh
K162053 09/15/2016 PhotonBlade Invuity Inc. John Kang
K162416 09/29/2016 IRIDEX Cyclo G6 Laser System, G-Probe Illuminate IRIDEX CORPORATION KATHY MAYNOR
K161746 09/21/2016 ARIX Hand System Jeil Medical Corporation Seungyong Lee
K160964 09/16/2016 Neodent Implant System - Titanium Base for CEREC JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA JACSON Cambruzzi
K161895 09/08/2016 2MP Color LCD Monitor CCL214 (CL21214) JVC KENWOOD Corporation Tsukasa Tashiro
K162264 09/21/2016 Cascadia Interbody System K2M, Inc. NANCY GIEZEN
K161112 09/17/2016 KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K151962 09/15/2016 KBL Sunlamp Products (= Device Bundling name) KBL AG NORBERT BECKER
K153469 09/01/2016 Cathtong I PICC Catheter L&Z US, INC. JENELLA COUTTS
K152981 09/02/2016 JET SET 4 DENTURE REPAIR RESIN LANG DENTAL MANUFACTURING COMPANY, INC DAVID LANG
K161173 09/28/2016 Avenue« T TLIF Cage LDR SPINE USA, INC. JOHN ROSSMAN
K160066 09/02/2016 Pro-Link« Stand-Alone Cervical Spacer System Life Spine, Inc. Randy Lewis
K160529 09/15/2016 Pledgeted COR-SUTURE QUICK LOAD LSI SOULTIONS KEVIN BENTLEY
K161573 09/02/2016 FilmArray RP EZ Control Panel M265 MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K161585 09/06/2016 Mano and Mano Personal Lubricant Mano and Mano Proprietary Limited Katrina Allen
K160117 09/09/2016 AbClose - Port Site Closure Device Medeon Biodesign, Inc GRETA CHANG
K160698 09/02/2016 LigaPASS MEDICREA INTERNATIONAL S.A. DAVID RYAN
K160640 09/23/2016 PASS XS Spinal System MEDICREA INTERNATIONAL S.A. David Ryan
K161602 09/02/2016 Arctic Sun Temperature Management System Medivance, Inc. Stacci Cronk
K161294 09/15/2016 Compound W Wart Removal System Dual Power MEDTECH PRODUCTS INC. JEAN BOYKO
K160860 09/22/2016 MiniMed Quick-serter MEDTRONIC MINIMED Noreen Bajwa
K153660 09/14/2016 StealthStation System with Cranial Software MEDTRONIC NAVIGATION, INC. Augusta Henao
K162384 09/22/2016 TrailBlazer Angled Support Catheter Medtronic Vascular, Inc.(formerly ev3 Inc.) David Robertson
K162016 09/21/2016 Affinity NT Oxygenator with Cortiva BioActive Surface MEDTRONIC, INC. RENEE CVEYKUS
K161392 09/01/2016 Elation Pulmonary Balloon Dilation MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K161879 09/21/2016 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K161803 09/30/2016 Traxcess .007 Mini Guidewire MICROVENTION, INC. SAPNA SINGH
K160429 09/01/2016 BC-5390 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Min Zheng
K161465 09/03/2016 CardioConfirm MORTARA INSTRUMENT, INC. Margaret Mucha
K160015 09/22/2016 Pure Vu Motus GI Medical Technologies Ltd. Hagit Ephrath
K161485 09/06/2016 Nanovis Intervertebral Body Fusion System and Forticore(R) NANOVIS LLC MATTHEW HEDRICK
K161866 09/08/2016 BioFlo Midline Catheter NAVILYST MEDICAL, INC. ROBIN FULLER
K162345 09/21/2016 UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge NEOTRACT, INC. LOUIS-PIERRE MARCOUX
K161519 09/11/2016 NeuroStar TMS Therapy System NEURONETICS, INC. JUDY P. WAYS
K162332 09/29/2016 Nexcore GI Insufflator NEXCORE TECHNOLOGY, LLC Julie Broderick
K160816 09/21/2016 Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) NEXMED TECHNOLOGY CO., LTD Ellen Xu
K161608 09/30/2016 InterForm Cervical Interbody Cage System NEXT ORTHOSURGICAL ELLEN YARNALL
K161165 09/07/2016 Next Science Irrigation Solution NEXT SCIENCE, LLC MATTHEW MYNTTI
K153707 09/02/2016 Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION TOM BENTO
K153665 09/15/2016 PROW FUSION-L NLT SPINE LTD Eti Zinger
K161792 09/20/2016 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies Inc. Jen Pendlebury
K161451 09/22/2016 BIB Stent Placement Catheter NUMED, INC. Nichelle LaFlesh
K160728 09/16/2016 NutraStim Hair Laser Helmet NUTRA LUXE MD LLC GLORIA AVENDANO
K161442 09/28/2016 NuVasive« CoRoent« Small InterlockÖ System NUVASIVE INCORPORATED Cynthia Adams
K161751 09/02/2016 MAGEC« Spinal Bracing and Distraction System NUVASIVE SPECIALIZED ORTHOPEDICS, INC. REBECCA SHELBURNE WALKER
K161014 09/28/2016 NuVasive« Reline« System NUVASIVE, INCORPORATED Thao Huynh
K162426 09/29/2016 nva, nvp, and nvt NVISION BIOMEDICAL TECHNOLOGIES, LLC Diana L. Langham
K161524 09/02/2016 Tangis Anterior Cervical Plate NVISION BIOMEDICAL TECHNOLOGIES, LLC DIANA L. LANGHAM
K161600 09/06/2016 Resection Electrodes OLYMPUS WINTER & IBE GMBH Katharina Campbell
K161263 09/13/2016 OptoMonitor II Opsens Inc Vanessa Mootoosamy
K161455 09/20/2016 Catalys Precision Laser System Optimedica Corporation Ankur Kaushal
K161129 09/08/2016 PILLAR SA PTC ORTHOFIX INC. Natalia Volosen
K162307 09/27/2016 OrthoPediatrics Locking Proximal Femur System Cortical Screws ORTHOPEDIATRICS, CORP. ADAM CARGILL
K161671 09/29/2016 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower OTICON MEDICAL AB Satu Hjartstam
K161832 09/23/2016 O2VENT T OVENTUS MANUFACTURING PTY LTD HEMANGI MALDE
K153302 09/08/2016 coflex-IF PARADIGM SPINE, LLC Marc Viscogliosi
K161506 09/26/2016 Penumbra Aspiration System Penumbra, Inc. Richard Kimura
K161966 09/08/2016 PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector PerkinElmer, Inc. Dawn Spooner
K161942 09/01/2016 PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector PERKINELMER, INC. Dawn Spooner
K162329 09/14/2016 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Philips Healthcare Maxs Newberry
K162112 09/21/2016 CAAS MRV Pie Medical Imaging BV Annemiek Bouts
K161876 09/09/2016 Tritium« Sternal Cable Plate System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Sarah Pleaugh
K153546 09/28/2016 PINK CAD/CAM disc POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY JANJA LIPUSCEK
K161814 09/27/2016 Solana Influenza A+B Assay Quidel Corporation Ronald H. Lollar
K160606 09/01/2016 BC-5D Hematology Control R & D SYSTEMS, INC. RAVI KOMMINENI
K160822 09/09/2016 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV RESMED LTD JASJIT BAVEJA
K161487 09/09/2016 VPAP Adapt SV, VPAP Tx, S9 VPAP Tx ResMed Ltd Jasjit Baveja
K161201 09/09/2016 ClearRead CT RIVERAIN TECHNOLOGIES, LLC Jennifer Butsch
K161212 09/30/2016 Atteris Antimicrobial Skin Protectant ROCHAL INDUSTRIES LLC William J. Coulston
K160493 09/08/2016 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm Salvin Dental Specialties Jennifer Singer
K160269 09/06/2016 Surgical Face Masks (Ear loops and Tie-on) SAN-M PACKAGE CO., LTD. Shogo Nagao
DEN150033 09/26/2016 Sensor Monitored Alimentary Restriction Therapy (SMART) Device SCIENTIFIC INTAKE William Longley
K161081 09/14/2016 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SEASPINE ORTHOPEDICS CORPORATION Michelle Willis
K161535 09/08/2016 SeaSpine« NewPortÖ Spinal System SEASPINE ORTHOPEDICS CORPORATION Michelle Willis
K152946 09/15/2016 TEMPEDY SEIRATHERM GMBH MATTHIAS ROTH
K161356 09/09/2016 Matrix LS-40 CO2 Laser System SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. Amy Lee
K162527 09/30/2016 8MP Color LCD Monitor (C81W+) Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K162267 09/06/2016 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD Zhai Pei
K152879 09/09/2016 Sure-Fine Insulin Syringes SHINA MED CORPORATION SUNG-SOON PARK
K161384 09/14/2016 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable Shockwave Medical, Inc. NORA HADDING
K151964 09/30/2016 Xprecia Stride Coagulation System, Xprecia System PT Controls SIEMENS HEALTHCARE DIAGNOSTICS NOOR MALKI
K161312 09/01/2016 Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH NILS NEUMANN
K161317 09/02/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Products GmbH Nils Neumann
K160724 09/07/2016 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. KATHLEEN DRAY-LYONS
K162221 09/06/2016 ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ultrasound Group Kevon Kong
K162339 09/21/2016 Scenium SIEMENS MEDICAL SOLUTIONS USA, INC VERONICA PADHARIA
K162417 09/28/2016 Acuson Freestyle Ultrasound System Siemens Medical Solutions, Inc. Lawrence Engle
K162243 09/06/2016 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Siemens Medical Solutions, Inc. Shelly Pearce
K162337 09/08/2016 Symbia 6.5 SIEMENS MEDICAL SOLUTIONS, USA, INC Cynthia Busch
K160159 09/06/2016 Active-X Total Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K153723 09/14/2016 ACTICOAT Surgical Dressing Smith & Nephew Medical Limited Samantha Neilson
K152163 09/29/2016 RENASYS GO SMITH & NEPHEW, INC. Laura Reynolds
K153636 09/09/2016 Liberator Powered Wheelchair with Solar Companion SOLAR MOBILITYLLC KURT SCHNEIDER
K162306 09/20/2016 SomnoDent ALPHA SomnoMed Inc. Kien Nguyen
K153701 09/09/2016 ULYSS Multi View Sinuscope SOPRO-COMEG GMBH HAROLD LETTAU
K161562 09/28/2016 Sound Options Tinnitus Treatment Sound Options Tinnitus Treatments Inc. Michael Chrostowski
K161774 09/30/2016 i-Sil SPIDENT Co., Ltd. J. M. Ahn
K161888 09/12/2016 JULIET« LL Lateral Lumbar Cage SPINEART FRANCK PENNESI
K162222 09/07/2016 GENflex2 Total Knee System StelKast, Inc. Dave Stumpo
K161086 09/20/2016 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Sterilmed, Inc. Patricia Kaufman
K161565 09/01/2016 DUO STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Juan Ye
K161946 09/16/2016 DoseCHECK Sun Nuclear Corporation Rene' Hardee
K162359 09/21/2016 Surefire Guiding Catheter Surefire Medical, Inc. Lynne Aronson
K161744 09/07/2016 Symmetry Sharp Kerrison Rongeur Symmetry Surgical Inc. Lora Tjomstol
K161043 09/12/2016 Profound System SYNERON CANDELA CORPORATION Ruthie Amir
K160167 09/26/2016 DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC Christopher J. Medberry
K161489 09/16/2016 Syntorr K-wire and Pin System SYNTORR INC DANIEL MARTIN
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