FDA 510(k) Applications Received During August, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K162375 08/24/2016 Envision 3D: Image Guidance System 7D SURGICAL INC. DANIEL ZISKIND
K162322 08/19/2016 the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model ACCESS SCIENTIFIC, LLC WALTER CORDIGLIA
K162348 08/22/2016 ABCcolla Collagen Matrix ACRO BIOMEDICAL CO., LTD DAR-JEN HSIEH
K162230 08/08/2016 Fully Automatic Electronic Blood Pressure Monitor ADON HEALTH CO., LTD. Liu Yi
K162134 08/01/2016 ENNOVATE Spinal System Aesculap Implant Systems, LLC Paul Amudala
K162228 08/08/2016 TorqVue Low Profile Delivery Catheter AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR Mary Johnson
K162160 08/02/2016 Preference Elite Pedicle Screw System AMEDICA CORPORATION Shanna Ryan
K162144 08/01/2016 iHealth Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD Liu Yi
K162316 08/18/2016 Pirouette 014 ArraVasc Ltd Aoife Donoghue
K162126 08/01/2016 Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthroCare Corporation Ashley M. Johnson
K162391 08/26/2016 AlignMATEÖ Lapidus Arthrodesis System ARTHROSURFACE, INC. PHANI PUPPALA
K162248 08/10/2016 Asahi ViE-U Series Dialyzer ASAHI KASEI MEDICAL CO., LTD. Masaharu Aritomi
K162336 08/22/2016 Contour Next EZ Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. Jennifer L. Gregory
K162153 08/02/2016 Integra« CAPTUREÖ Screw System & Integra« Ti6« Internal Fixation System ASCENSION ORTHOPEDICS GABRIELLA BECKER
K162392 08/26/2016 Avazzia AVAZZIA, INC. TAMMY LAHUTSKY
K162326 08/19/2016 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled Avinger, Inc Patty Hevey
K162342 08/22/2016 Stellaris Elite Vision Enhancement System Bausch + Lomb Ken Nehmer
K162208 08/05/2016 DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent BECKMAN COULTER INC. Geraldine Fuentespina
K162414 08/29/2016 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System BECKMAN COULTER, INC. NANCY NADLER
K162380 08/24/2016 Locking Plate System BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. CINDY NIE
K162398 08/26/2016 CO2 Laser Therapy Systems BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. XIN WANG
K162431 08/31/2016 Luna 3D Interbody Fusion System Benvenue Medical, Inc. Jeff Emery
K162180 08/04/2016 Disposable Insulin Syringe BERPU MEDICAL TECHNOLOGY CO., LTD JUNDONG TAN
K162232 08/08/2016 MOSS 100 Pedicle Screw System Biedermann Motech GmbH & Co. KG Gerd Federle
K162373 08/24/2016 LC Bead LUMI Biocompatibles UK Limited Simon Leppard
K162385 08/25/2016 RAPIDEC CARBA NP BIOMERIEUX SA ASA KARLSSON
K162424 08/30/2016 Ulna Plating System BIOMET INC Julie Largent
K162407 08/29/2016 L300 Go System BIONESS INC. MERCEDES BAYANI
DEN160040 08/05/2016 Embosphere Microspheres Biosphere Medical S.A. Alix Fonlladosa
K162192 08/04/2016 BluePro BlueSom Erwan Floch
K162205 08/05/2016 Arc EndoCuff and Arc EndoCuff Vision BODDINGTONS PLASTICS LTD SARAH GIBSON
K162350 08/23/2016 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Boston Scientific Corporation Ka Zoua Xiong
K162404 08/29/2016 Express SD Biliary Monorail Premounted Stent System BOSTON SCIENTIFIC CORPORATION Ka Zoua Xiong
K162186 08/04/2016 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K162294 08/15/2016 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS BRIGHTWAY HOLDINGS SDN BHD. G. BASKARAN
K162146 08/01/2016 Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) BRIGHTWAY HOLDINGS SDN BHD. G. BASKARAN
K162193 08/04/2016 XenMatrix AB Surgical Graft C.R. Bard Tony John
K162441 08/31/2016 PowerPICC Provena Catheters with SOLO Valve Technology C.R. BARD, INC BRYAN STONE
K162377 08/24/2016 PowerGlide Pro Midline Catheter C.R. BARD, INC. JACOB LEE
K162443 08/31/2016 PowerPICC Provena Catheters C.R. BARD, INC. BRYAN STONE
K162383 08/25/2016 Cadwell Sierra Summit, Cadwell Sierra Ascent CADWELL INDUSTRIES, INC. CHRISTOPHER BOLKAN
K162199 08/05/2016 Cascade IOMAX Intraoperative Monitor CADWELL INDUSTRIES, INC. MELISSA KIRKUP
K162201 08/05/2016 Desara TV, Desara Blue TV CALDERA MEDICAL, INC. Vicki Gail
K162121 08/01/2016 Siconus SI Joint Fixation System CAMBER SPINE TECHNOLOGIES DAMIAN HEINZ
K162394 08/26/2016 CRC-77tHR Capintec, Inc. Mary Anne Yusko
K162214 08/08/2016 Protek Solo 24 Fr Venous Cannula Set CARDIAC ASSIST, INC. GREG JOHNSON
K162181 08/04/2016 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set CARDIACASSIST INC. GREG JOHNSON
K162440 08/31/2016 CardioInsight Cardiac Mapping System CARDIOINSIGHT TECHNOLOGIES, INC LAURIE LEWANDOWSKI
K162432 08/31/2016 Multi-Link X2 ECG Cable and Lead Wire System CAREFUSION 2200 INC. ERIKA FERNANDEZ
K162178 08/04/2016 CareView 1500P X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. XU WEI
K162254 08/10/2016 Cedic Enteral ENFit Transition Connectors CEDIC S.R.L. TIZIANA MELIS
K162444 08/31/2016 Xpert MRSA NxG CEPHEID SCOTT A. CAMPBELL
K162331 08/19/2016 Xpert Xpress Flu/RSV, 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
K162352 08/23/2016 derma+flex QS High Viscosity Tissue Adhesive CHEMENCE MEDICAL INC Kenneth Broadley
K162172 08/03/2016 EBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. QIFEI LIU
K162367 08/23/2016 Erisma« LP MIS CLARIANCE SAS Pascal ROKEGEM
K162224 08/08/2016 ArtPix Mobile EZ2GO CMT MEDICAL TECHNOLOGIES, LTD. LILIA SCHLOSBERG
K162437 08/31/2016 Codman EDS3 CSF External Drainage System Codman & Shurtleff, Inc. Christopher Garete
K162158 08/02/2016 Porcine Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. Peggy Hansen
K162405 08/29/2016 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHAN YEW MEN
K162127 08/01/2016 Bencox M Stem Lateralized & Bencox Mirabo Cup System CORENTEC CO., LTD J. S. DANIEL
K162253 08/10/2016 Trapper Exchange Device CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL ORLA HICKEY
K162388 08/25/2016 CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) CURASEAL, INC. HAROLD F. CARRISON
K162120 08/01/2016 Scope-Assist Flushing Sink Custom Ultrasonics Inc. Elizabeth Lazaro
K162231 08/08/2016 iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert CYDEN LIMITED MIKE KIERNAN
K162397 08/26/2016 Titan 3 Low Speed Angle Attachments DENTALEZ, INC Dan Laskowitz
K162124 08/01/2016 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins DePuy Synthes CHRISTOPHER J. MEDBERRY
K162227 08/08/2016 STA« - Liatest« D-Di Diagnostica Stago Arnaud Berthier
K162297 08/16/2016 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set Diazyme Laboratories Abhijit Datta
K162220 08/08/2016 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage DIO MEDICAL CO., LTD SUNG HEE-LEE
K162421 08/30/2016 IntelliCartTM System DORNOCH MEDICAL SYSTEMS LARRY SMITH
K162283 08/15/2016 DCM Kyphoplasty System Dragon Crown Medical Co., Ltd. Zhi Yong Song
K162408 08/29/2016 Nano Varnish, Plaquit, Lightpaint on Surface DREVE DENTAMID GMBH REINER ALTMANN
K162285 08/15/2016 EBM iDO Viewer 1.2.1 EBM Technologies Incorporated John Su
K162184 08/04/2016 Edwards eSheath Introducer Set Edward Lifesciences Yi Gao
K162140 08/01/2016 RemLogic EMBLA SYSTEMS SHANE T. SAWALL
K162197 08/05/2016 EndoClot EndoClot Plus Co., Ltd. Hendry Zhang
K162152 08/02/2016 ErbeÆs CO2 Tubing/Cap Sets Erbe USA, Inc. John Tartal
K162290 08/15/2016 MyLabSix CrystaLine ESAOTE S.P.A. MASSIMO POLIGNANO
K162167 08/03/2016 Caphosol Artifical Saliva Tablets EUSA Pharma (UK) Limited Paul Davisson
K162325 08/19/2016 Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw Exactech Inc Zach Sharrah
K162150 08/02/2016 BreathID Hp Lab System Exalenz Bioscience Ltd. Raffi Werner
K162319 08/19/2016 BabyDance Fertility Lubricant Fairhaven Health, LLC Suzanne Munson
K162176 08/03/2016 Fiagon Navigation System Fiagon GmbH Dirk Mucha
K162287 08/15/2016 Synapse 3D Perfusion Analysis FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Jyh-Shyan Lin
K162288 08/15/2016 SonoSite iViz Ultrasound System FUJIFILM SONOSITE, INC. Patricia Liau
K162268 08/12/2016 Senographe Pristina GE HEALTHCARE Gregory Pessato
K162269 08/12/2016 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K162403 08/29/2016 HyperBand GE Medical Systems, LLC Jason Ma
K162409 08/29/2016 Gems Vitrification Set, Gems Warming Set GENEA BIOMEDX PTY LTD Kea Dent
K162315 08/18/2016 FORTIFY Corpectomy Spacers GLOBUS MEDICAL INC. Kelly J. Baker
K162207 08/05/2016 Restore Moisturizing Vaginal Lubricant Good Clean Love Wendy Strgar
K162299 08/16/2016 Spiral Shape Dental Implant System GP Implants Pivovarov German
K162179 08/04/2016 osteo-WEDGE II « Open Wedge Bone Locking Plate System GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA Angela Recchia
K162442 08/31/2016 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. Martin D. Paugh
K162234 08/09/2016 Truscope Ultra Patient Monitor GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jing Liang
K162333 08/22/2016 Wondfo One Step Fecal Occult Blood (FOB) Test GUANGZHOU WONDFO BIOTECH CO., LTD. Bin Chen
K162423 08/30/2016 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System HAEMONETICS CORPORATION MARK ANZALONE
K162338 08/22/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K162381 08/24/2016 HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs HEALTHY GLOVE CO., LTD Teoh Choh Shee
K162390 08/26/2016 ET Hybrid Abutment HIOSSEN INC. David Kim
K162412 08/29/2016 Hoggan Scientific« microFET2Ö Hoggan Scientific, LLC Spencer Walker
K162314 08/18/2016 IMACTIS CT-Navigation system IMACTIS, SAS MADY BATAILH
K162344 08/22/2016 INNOLUX RIC INNOLUX CORPORATION Andy Kuo
K162236 08/09/2016 Ax Stand-Alone ALIF System INNOVASIS, INC. Marshall McCarty
K162143 08/01/2016 FixxSure« X-Link INNOVASIS, INC. MARSHALL MCCARTY
K162251 08/10/2016 Reprocessed Viking Diagnostic Electrophysiology Catheters Innovative Health, LLC. Sharon Higgins
K162311 08/18/2016 Straumann PrefGel INSTITUT STRAUMANN AG CHRISTOPHER KLACZYK
K162296 08/16/2016 OmniPod Insulin Management System INSULET CORPORATION MATTHEW KING
K162364 08/23/2016 Intellijoint HIP Generation 2A System INTELLIJOINT SURGICAL INC. BRANDON GINGRICH
K162411 08/29/2016 da Vinci Xi 12 û 8 mm Reducer Intuitive Surgical, Inc. Vishal Kanani
K162203 08/05/2016 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K162177 08/04/2016 dS FootAnkle I6CH 1.5T Coil Invivo Corporation Ken Revennaugh
K162416 08/30/2016 IRIDEX Cyclo G6 Laser System, G-Probe Illuminate IRIDEX CORPORATION KATHY MAYNOR
K162265 08/11/2016 CushionCast Moldable Cushions IZI Medical Products LLC Qiang Cao
K162169 08/03/2016 EdgeOne CO2 Laser Jeisys Medical Inc. Erica Seo
K162264 08/11/2016 Cascadia Interbody System K2M, Inc. NANCY GIEZEN
K162427 08/30/2016 Vado Bi-Directional Steerable Sheath KALILA MEDICAL, INC. CARRIE NEUBERGER
K162410 08/29/2016 TIPCAM 1S 3D System KARL STORZ Endoscopy America, Inc Winkie Wong
K162386 08/25/2016 KATOR Suture Anchor KATOR LLC Robert Hoy
K162436 08/31/2016 EndoVac Pure Kerr Corporation Mohammad Saad Ansari
K162164 08/03/2016 GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord KERR CORPORATION MOHAMMAD SAAD ANSARI
K162257 08/11/2016 P1145 Dental Restorative Kerr Corporation Mohammad Saad Ansari
K162136 08/01/2016 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System L&K BIOMED CO.,LTD. Yerim An
K162216 08/08/2016 GRI-FILL PERISTALTIC SET LABORATORIOS GRIFOLS, S.A. MARTA DANIELA SERRA DE FORTUNY
K162235 08/09/2016 LUVENA VAGINAL MOISTURIZER & LUBRICANT LACLEDE, INC. MICHAEL PELLICO
K162133 08/01/2016 VerteFIT Corpectomy Cage System LDR SPINE USA, INC. JAMIE WILSON
K162323 08/19/2016 Tooth Shade Resin Material LIAONING UPCERA CO.,LTD Charles Shen
K162266 08/11/2016 The Cranial Fusion System LIFE SPINE INC. RANDY LEWIS
K162445 08/31/2016 LiVac Retractor System Livac Pty Ltd Anabela Correia
K162428 08/30/2016 DiLumen Endolumenal Interventional Platform Lumendi, LLC Dennis Daniels
K162210 08/05/2016 touchTymp MAICO DIAGNOSTICS GMBH UWE LEDWORUSKI
K162273 08/12/2016 Materialise TKA Guide System MATERIALISE NV OLIVER CLEMENS
K162119 08/01/2016 UreTron PF Series Probe MED-SONICS CORP. JENNIFER RAUTINE
K162389 08/26/2016 Medcomp Vessel Dilator MEDCOMP ( MEDICAL COMPONENTS) COURTNEY NIX
K162271 08/12/2016 Pro-Lock CT Safety Infusion Set MEDCOMP (MEDICAL COMPONENTS, INC.) COURTNEY NIX
K162194 08/05/2016 MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System MEDICREA INTERNATIONAL S.A DAVID RYAN
K162434 08/31/2016 NC Gallant PTCA Catheter MEDINOL LTD. MICHAL HERSHKOVITZ
K162128 08/01/2016 Scope Buddy Plus Endoscope Flushing Aid MEDIVATORS INC. Kristin Bergeson Padilla
K162247 08/10/2016 PERMATAPE MEDOS INTERNATIONAL SARL TATYANA KORSUNSKY
K162327 08/19/2016 COUGAR« LS Lateral Cage System and COUGAR« System Medos International, Sarl Eric Zhu
K162330 08/19/2016 Flex Robotic System and Flex Colorectal Drive Medrobotics Corporation John D. Bonasera
K162309 08/17/2016 StealthStation S8 System Platforms and StealthStation Cranial Software MEDTRONIC NAVIGATION, INC. Tia Fushimi-Bain
K162379 08/24/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. Nathaniel Hendricks
K162212 08/08/2016 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K162384 08/25/2016 TrailBlazer Angled Support Catheter Medtronic Vascular, Inc.(formerly ev3 Inc.) David Robertson
K162226 08/08/2016 Reliant Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) CO., Ltd. Becky Li
K162419 08/30/2016 FIREFLY« Pedicle Screw Navigation Guide MIGHTY OAK MEDICAL INC. Mark A. Wylie
K162395 08/26/2016 MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup MP BIOMEDICALS, LLC STAR HAN
K162378 08/24/2016 FREND PSA PLUS (reagent cartridge) NANOENTEK USA INC SUNMI HAN
K162250 08/10/2016 FortiBridge Anterior Cervical Plate System NANOVIS SPINE LLC MATTHEW HEDRICK
K162345 08/22/2016 UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge NEOTRACT, INC. LOUIS-PIERRE MARCOUX
K162332 08/19/2016 Nexcore GI Insufflator NEXCORE TECHNOLOGY, LLC Julie Broderick
K162308 08/17/2016 Noris Medical MBI-2mm Dental Implant System Noris Medical Ltd Simha Sibony
K162218 08/08/2016 Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 NUANCE MEDICAL, LLC MARC LIEBERMAN
K162371 08/24/2016 Pulsaderm ACE-All Blue Nutra Luxe MD, LLC Gloria Avendano
K162313 08/18/2016 NuVasive Next Generation NVM5 System NUVASIVE INCORPORATED MARY ADAMS
K162138 08/01/2016 NuVasive CoRoent Small Ti-C System NUVASIVE, INCORPORATED MICHELLE CHEUNG
K162426 08/30/2016 nva, nvp, and nvt NVISION BIOMEDICAL TECHNOLOGIES, LLC Diana L. Langham
K162361 08/23/2016 Soft Plug Extended Duration 180 Canalicular Plug OASIS MEDICAL, INC. JAMES CHRISTENSEN
K162217 08/08/2016 LOYON Oculus Innovative Sciences Brian W. Martin
K162191 08/04/2016 NAVILAS Laser System OD-OS GMBH WINFRIED TEIWES
K162430 08/31/2016 UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD. KE-MIN JEN
K162209 08/05/2016 Sapphire NC Plus OrbusNeich Medical, Inc John D. Pazienza
K162355 08/23/2016 Raycast MammoRx Carbon Fibre Breast Board Orfit Industries NV Eddy Marivoet
K162307 08/17/2016 OrthoPediatrics Locking Proximal Femur System Cortical Screws ORTHOPEDIATRICS, CORP. ADAM CARGILL
K162366 08/23/2016 Omega VL OV WORLD CO., LTD GEUNG-GYU GANG
K162433 08/31/2016 GCE Zen-O Portable Oxygen Concentrator OXUS, INC RYAN LENARCIC
K162154 08/02/2016 Pantheon Medical Balanced Plating System PANTHEON MEDICAL TRAVID BIRD
K162241 08/10/2016 TITAN 3-DÖ Wedge System PARAGON 28 Frank S. Bono
K162198 08/05/2016 GFS Ultimate PARCUS MEDICAL, LLC PAUL VAGTS
K162233 08/08/2016 Kurin Blood Culture Collection Set Pathway LLC Emily Davis
K162151 08/02/2016 PENTAX Medical ENT Video Imaging System PENTAX OF AMERICA, INC. Krishna Govindarajan
K162329 08/19/2016 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Philips Healthcare Maxs Newberry
K162148 08/01/2016 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jeanette Becker
K162418 08/30/2016 Pioneer Plus Catheter PHILIPS VOLCANO MARY STANNERS
K162376 08/24/2016 CAAS MR 4D Flow PIE MEDICAL IMAGING B.V. ANNEMIEK BOUTS
K162362 08/23/2016 PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS DERYA DIKICI
K162282 08/15/2016 CardioChek Plus Test System, CardioChek Home Test System Polymer Technology Systems, Inc. d/b/a PTS Diagnostics Margo Enright
K162211 08/08/2016 AccuFit Lateral Plate System PRECISION SPINE, INC. Michael C. Dawson
K162300 08/16/2016 Reform« POCT System PRECISION SPINE, INC. MICHAEL C. DAWSON
K162240 08/09/2016 ProMedTek Model C1400 Shortwave Diathermy Device PROMEDTEK INC. Dan Puchek
K162246 08/10/2016 ProNova SC360 Proton Therapy System ProNova Solutions, LLC ADAM KUHN
K162284 08/15/2016 Puritan Fecal Opti-Swab Collection and Transport System PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI
K162372 08/24/2016 QT Ultrasound Breast Scanner-1 QT ULTRASOUND LLC ELAINE IUANOW
K162196 08/05/2016 Dell UP3216Q with QUBYX PerfectLum bundle QUBYX SOFTWARE TECHNOLOGIES INC. MARC LEPPLA
K162276 08/12/2016 SeraQuest Herpes Type 1 Specific IgG QUEST INTERNATIONAL, INC DAVID J. KIEFER
K162304 08/17/2016 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets QUEST MEDICAL, INC. Amy Clendening-Wheeler
K162438 08/31/2016 Sofia Influenza A+B FIA on Sofia 2 Quidel Corporation Jennifer S. Rial
K162274 08/12/2016 Solana Strep Complete Assay Quidel Corporation Ronald H Lollar
K162275 08/12/2016 Randox RX Daytona Plus Alkaline Phosphatase (ALP) RANDOX LABORATORIES LIMITED Pauline Armstrong
K162200 08/05/2016 Randox RX Daytona Plus Magnesium (MG) RANDOX LABORATORIES LTD PAULINE 0 ARMSTRONG
K162131 08/01/2016 ExSpiron 1Xi Respiratory Motion Inc. Edwin Rule
K162321 08/19/2016 EasyClip Xpress RESTORE SURGICAL LLC dba Instratek JEFF SEAVEY
K162173 08/03/2016 Elecsys CYFRA 21-1 CalCheck 5 Roche Diagnostics Adam Clark
K162278 08/15/2016 Digital Diagnostic Mobile X-ray System SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K162351 08/23/2016 SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device SEASPINE ORTHOPEDICS CORPORATION Gina Flores
K162281 08/15/2016 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) SEBIA KAREN ANDERSON
K162312 08/18/2016 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color SHEN WEI USA INC. CHERYL BAILEY-KROLL
K162267 08/11/2016 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD Zhai Pei
K162261 08/11/2016 CERAMAGE UP SHOFU DENTAL CORPORATION MAURO MALZYNER
K162298 08/16/2016 LOCI Total Vitamin D Total Assay, LOCI VITD CAL SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN DRAY-LYONS
K162420 08/30/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PETRA DISSMANN
K162399 08/26/2016 Atellica CH Magnesium (Mg) SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA J. DUGGAN
K162221 08/08/2016 ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ultrasound Group Kevon Kong
K162339 08/22/2016 Scenium SIEMENS MEDICAL SOLUTIONS USA, INC VERONICA PADHARIA
K162302 08/17/2016 Somatom Confidence « RT Pro SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K162370 08/24/2016 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Kimberly Mangum
K162417 08/30/2016 Acuson Freestyle Ultrasound System Siemens Medical Solutions, Inc. Lawrence Engle
K162243 08/10/2016 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Siemens Medical Solutions, Inc. Shelly Pearce
K162337 08/22/2016 Symbia 6.5 SIEMENS MEDICAL SOLUTIONS, USA, INC Cynthia Busch
K162303 08/17/2016 REDAPT Sleeved Monolithic Revision Stems SMITH & NEPHEW INC. KIM PHAN
K162129 08/01/2016 RENASYS-G Gauze Dressing Kits with Soft Port Smith & Nephew, Inc. Laura Reynolds
K162219 08/08/2016 CADD« Infusion Disposables Portfolio with NRFitÖ connectors Smiths Medical ASD, Inc. Wendy J. Kivens
K162356 08/23/2016 Vesair Cystoscopic Sheath Solace Therapeutics William Gruber
K162402 08/26/2016 4CIS« Marlin ACIF Cage System SOLCO BIOMEDICAL CO., LTD. KIM IL
K162306 08/17/2016 SomnoDent ALPHA SomnoMed Inc. Kien Nguyen
K162215 08/08/2016 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae SORIN GROUP ITALIA S.R.L Luigi Vecchi
K162317 08/19/2016 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens ST. SHINE OPTICAL CO., LTD. ELLA LEE
K162162 08/02/2016 Barrier Supreme Sterilization Wrapper Standard Textile Co., Inc. Bradley J. Bushman
K162222 08/08/2016 GENflex2 Total Knee System StelKast, Inc. Dave Stumpo
K162413 08/29/2016 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K162161 08/02/2016 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated Elizabeth Greene
K162262 08/11/2016 Tritanium« PL Cage STRYKER Deirdre Jayko
K162310 08/17/2016 XBraid TT Suture Tape Stryker Taylor White
K162439 08/31/2016 AxSOS 3 Ti; Stryker Plating System STRYKER GMBH Irene Bacalocostantis
K162341 08/22/2016 Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co. KG N/A N/A
K162171 08/03/2016 S4 Screw SystemÖ SUBCHONDRAL SOLUTIONS SHERYL MCCOY
K162165 08/03/2016 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump SUMMIT MEDICAL PRODUCTS, INC LeVoy Haight
K162223 08/08/2016 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) SUPERVISION OPTIMAX SDN BHD YAP PEAK GEEH
K162359 08/23/2016 Surefire Guiding Catheter Surefire Medical, Inc. Lynne Aronson
K162125 08/01/2016 MALUCÖ Total Hip Arthroplasty System SurgTech, Inc., Xuegong Yu
K162163 08/02/2016 UltraShape System SYNERON MEDICAL LTD Ruthie Amir
K162358 08/23/2016 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System SYNTHES USA PRODUCTS LLC Eugene Bang
K162382 08/24/2016 Smart Dongle Blood Glucose Monitoring System TaiDoc Technology Corporation Paul Liu
K162242 08/10/2016 Comfort Flo Humidification System TELEFLEX MEDICAL, INC BRIAN GALL
K162396 08/26/2016 SILK Surgical Suture TELEFLEX MEDICAL, INC NATALIE HICHAK
K162365 08/23/2016 T-Cuff Terumo BCT, Inc. Nithya Rajan
K162263 08/11/2016 Optilite Rheumatoid Factor Kit THE BINDING SITE GROUP LTD. JON LAUDER
K162195 08/05/2016 TSolution One Cup1 Surgical System THINK SURGICAL INC. IN K. MUN
K162258 08/11/2016 Self Sealing Sterilization Pouches Tianchang Jiarui Packaging Material Co., Ltd. Zhang Ruiqing
K162387 08/25/2016 U-IGNITE Bladeless Trocar TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. TAO FAN
K162183 08/04/2016 Vantage Galan 3T, MRT-3020, V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162187 08/04/2016 Xario 100 Diagnostic Ultrasound System, V5.0 Toshiba Medical Systems Corporation Paul Biggins
K162155 08/02/2016 Xario 200 Diagnostic Ultrasound System V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162256 08/11/2016 Klassic Femur, Porous, Klassic Tibial Baseplate, Porous TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K162422 08/30/2016 Klassic Knee System Total Joint Orthopedics, Inc. Chris Weaber
K162354 08/23/2016 Sniper Staple System TRILLIANT SURGICAL LTD Jon Olson
K162189 08/04/2016 ANAXÖ 5.5 Spinal System U&I Corporation Ji Yea Lee
K162334 08/22/2016 U.S. Laser Worx Patriot 1 family of lasers U.S. Laser Worx Frank Ford
K162415 08/29/2016 Spectra 9Plus Uzinmedicare Company Nathan Ahn
K162272 08/12/2016 Fluent inflation device VASCULAR SOLUTIONS, INC. BEKA VITE
K162252 08/10/2016 FasTouch Fixation System VIA SURGICAL LTD. OFEK LEVIN
K162175 08/03/2016 Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less Viet Glove Corporation PHAM NGOC THANH
K162393 08/26/2016 The ViewRay (MRIdian) Linac System VIEWRAY INCORPORATED SEAN DELANEY
K162190 08/04/2016 Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) VILLA SISTEMI MEDICALI S.P.A. PAOLO CASAGRANDE SANTIN
K162363 08/23/2016 V30 system, V-Form Handpiece BC Medium applicator Viora Ltd. Stella Raizelman Perry
K162145 08/01/2016 vRad PACS with Mammography Virtual Radiologic Corporation Melinda Sewell
K162137 08/01/2016 Fever ScoutÖ Continuous Monitoring thermometer VivaLnk Inc. Cecilia Xi
K162159 08/02/2016 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing VR Medical Technologies, LLC Lee Pan
K162188 08/04/2016 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) VR MEDICAL TECHNOLOGY LEE PAN
K162340 08/22/2016 Stomach Tube WELL LEAD MEDICAL CO., LTD HUANG KAI GEN
K162225 08/08/2016 WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System WellDoc, Inc Michele Livingston
K162343 08/22/2016 Westmed Gas Sampling Cannula with O2 delivery WESTMED, INC. DIANA UPP
K162142 08/01/2016 Accessory Irrigation Adapter WILSON-COOK MEDICAL, INC. THERESA DE PRAT
K162328 08/19/2016 Winner Transfer Wheelchair Winner SG Pte Ltd Michael Pang
K162353 08/23/2016 MICATM Screw System WRIGHT MEDICAL TECHNOLOGY, INC. TARA CONRAD
K162141 08/01/2016 Restore PACS XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. Echo Chou
K162237 08/09/2016 XO1 Knee Balancing System XPANDORTHO, INC. REBECCA K PINE
K162206 08/05/2016 Zavation IBF Zavation, LLC Lawrence Walker
K162259 08/11/2016 DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) ZIBO DAIYANG PLASTIC COMPANY YANG YAN HONG
K162429 08/30/2016 ZipE Knotless Tissue Repair and Attachment Devices ZIPTEK, LLC William F. Bennett


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