FDA 510(k) Applications Received During November, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K153387 11/23/2015 Luna CPAP and Auto CPAP System 3B MEDICAL, INC. ALEX LUCIO
K153410 11/25/2015 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M COMPANY Melissa Forth
K153174 11/03/2015 Ketac Universal Aplicap 3M DEUTSCHLAND GMBH RUEDIGER FRANKE
K153436 11/27/2015 LATERAL Spine Truss System 4Web, Inc. Jessee Hunt
K153330 11/19/2015 FreeStyle Precision Neo H Blood Glucose Monitoring System Abbott Diabetes Care Inc. Arul Sterlin
K153375 11/23/2015 ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls ABBOTT LABORATORIES LAURA YELVIGI JOGLEKAR
K153357 11/20/2015 i-STAT Alinity System with i-STAT Sodium test ABBOTT POINT OF CARE INC. MELISSA ROBINSON
K153341 11/19/2015 Relieva Scout Multi-Sinus Dilation System ACCLARENT, INC. JAMES PATRICK GARVEY
K153207 11/05/2015 Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC GREGORY KOWALCZYK
K153412 11/25/2015 Sleep Profiler ADVANCED BRAIN MONITORING, INC. DANIEL J. LEVENDOWSKI
K153396 11/24/2015 Aesculap OrthoPilot Next Generation AESCULAP IMPLANT SYSTEMS, LLC Paul Amudala
K153335 11/19/2015 AlertWatch: OR ALERTWATCH LLC Justin Adams
K153424 11/25/2015 E-CUBE i7 ALPINION MEDICAL SYSTEMS CO., LTD. Donghwan KIM
K153152 11/02/2015 Syzygy Stabilization System AMENDIA, INC. Kristen Allen
K153286 11/12/2015 iHealth Align Gluco-Monitoring system Andon health Co., Ltd Yi Liu
K153278 11/12/2015 Wireless Smart Gluco-Monitoring System Andon Health Co., Ltd Yi Liu
K153200 11/04/2015 SnoreRx Apnea Sciences Corporation James Fallon
K153288 11/13/2015 Voyant Open Fusion Device APPLIED MEDICAL RESOURCES JESSICA CHO
K153416 11/25/2015 ArcScan Insight 100 ARCSCAN, INC. Andy Levien
K153423 11/25/2015 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) JULIE LAWSON
K153218 11/05/2015 Arthrex Synergy UHD4 System ARTHREX, INC. DAVID L ROGERS
K153186 11/03/2015 Adjustable Fixation Device ARTHROCARE CORP. Katherine Marcaccio
K153313 11/17/2015 SpeedLock Knotless Fixation System ARTHROCARE CORPORATION LAURA KASPEROWICZ
K153443 11/27/2015 ASAHI Astato XS 40 ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K153344 11/19/2015 Asahi REXEED-S Series Dialyzer Asahi Kasei Medical Co., Ltd. Hidenobu Nakazawa
K153446 11/27/2015 OLYMPIC Posterior Spinal Fixation System Astura Medical Troy Taylor
K153165 11/02/2015 NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit ASTUTE MEDICAL, INC Karin Hughes
K153297 11/13/2015 Perifix and Contiplex Catheter B. BRAUN MEDICAL INC LISA GIAQUINTO
K153293 11/13/2015 Extension Set B. BRAUN MEDICAL INC. Kimberly Smith
K153158 11/02/2015 Solution Administration Sets with 0.2 Micron Filter BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K153210 11/05/2015 Defibrillator Analyzer Variable Load BC GROUP INTERNATIONAL, INC Mel Roche
K153257 11/10/2015 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY MATTHEW TRACHTENBERG
K153309 11/17/2015 BD Vacutainer UltraTouch Push Button Blood Collection Set BECTON, DICKINSON AND COMPANY Pasquale Amato
K153398 11/24/2015 Comprehensive SRS/Nexel Elbow BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K153270 11/12/2015 TruGuard Custom Tongue and Jaw Positioner BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K153229 11/06/2015 Superbium BIOS S.R.L Riccardo Pisati
K153205 11/04/2015 IDSS ForceTriad Control Module BLACK DIAMOND VIDEO, INC Ragunath Muniandy
K153190 11/03/2015 Zenysis Short-Term Dialysis Catheter C.R BARD INC. SILVIA DE LA BARRA
K153440 11/27/2015 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set C.R BARD, INC. Darlene Hull
K153393 11/24/2015 PowerMidline Catheter C.R. BARD, INC Casey Coombs
K153298 11/13/2015 AccuCath Intravascular Catheter C.R. Bard, Inc. Casey Coombs
K153359 11/20/2015 BardPort«, SlimPort«, and X-Port« Implanted Ports C.R. BARD, INC. JAMES R. DAVIS
K153280 11/12/2015 PowerGlide Pro Midline Catheter C.R. BARD, INC. CASEY COOMBS
K153236 11/09/2015 Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay C.R. BARD, INC. SHWETA CONNER
K153312 11/17/2015 SCATTER CORRECTION FOR CXDI SERIES CANON, INC SHINJI MORI
K153295 11/13/2015 TandemLung Oxygenator CARDIAC ASSIST, INC. GREG JOHNSON
K153316 11/17/2015 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) Cardinal Health, Inc. Megan Middaugh
K153234 11/09/2015 AirLife Adult Heated Wire Circuit CAREFUSION INC ERIKA FERNANDEZ
K153181 11/03/2015 MAIA CENTERVUE SPA ROBERTO GABRIOTTI
K153192 11/03/2015 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests Chemtron Biotech, Inc. Jane Zhang
K153326 11/19/2015 Erisma-LP Spinal Fixation System CLARIANCE, SAS PASCAL ROKEGEM
K153245 11/09/2015 Baha 5 Super Power Sound Processor COCHLEAR AMERICAS TRISTAN MANUS
K153347 11/20/2015 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit CODMAN & SHURTLEFF, INC. Megan Herman
K153397 11/24/2015 S-Wire Guidewire System CONCERT MEDICAL, LLC Timothy S. Powers
K153217 11/05/2015 ConforMIS iTotal Posterior Stabilized Knee Replacement System ConforMIS, Inc. Amita Shah
K153197 11/04/2015 Fortress Introducer Sheath SYstem CONTRACT MEDICAL INTERNATIONAL GMBH JAN KLOBOUCNIK
K153430 11/25/2015 Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select COOK INCORPORATED SARAH REEVES
K153211 11/05/2015 M-Fix Acromioclavicular Device CORACOID SOLUTIONS, INC. STEVE GOLDEN
K153381 11/23/2015 Corin Metafix Hip Stem Corin USA Limited Rachel King
K153371 11/23/2015 Sonicision Cordless Ultrasonic Dissection Device COVIDIEN LLC NANCY SAUER
K153215 11/05/2015 SmartBase for Arthrex Glenoid IRIS Custom Orthopaedic Solutions, Inc. Keith Grafmeyer
K153328 11/19/2015 SUNCO Mechanical Wheelchair, model SKW-9003 DANYANG SUNCO MACHINERY CO., LTD JEN KE-MIN
K153191 11/03/2015 Calcium Bridge DENALI CORPORATION Jan G Stannard
K153411 11/25/2015 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece DENTALEZ, INC. DAN LASKOWITZ
K153268 11/12/2015 NR Line Implant System DENTIUM CO., LTD. YOUNJUNG YUK
K153394 11/24/2015 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator Diazyme Laboratories Abhijit Datta
K153224 11/06/2015 VitalStim(R) Plus Electrotherapy System DJO, LLC Natalia Shirina
K153354 11/20/2015 3MP Color LCD Monitor, RadiForce RX350 EIZO CORPORATION Hiroaki Hashimoto
K153353 11/20/2015 SANDMAN ELITE EMBLA SYSTEMS SHANE T. SAWALL
K153333 11/19/2015 Epic Extremity Cannulated Screw System Epic Extremity, LLC Dan Schwartzbauer
K153340 11/19/2015 Epic Extremity Plate System Epic Extremity, LLC DAN SCHWARTZBAUER
K153164 11/02/2015 LunulaLaser ERCHONIA MEDICAL, INC. STEVE SHANKS
K153277 11/12/2015 6200 Ultrasound System and 6250 Ultrasound System Esaote S.p.A. Donatella Ragghianti
K153303 11/16/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgG) EUROIMMUN US, INC. Michael Locke
K153308 11/17/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgM) EUROIMMUN US, INC. Michael Locke
K153305 11/16/2015 EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear EYEYON MEDICAL MALCA CHEN-ZION
K153372 11/23/2015 Repagyn vaginal suppositories FARMA-DERMA S.R.L. MARA CALZOLARI
K153243 11/09/2015 Fehling-Punches Fehling Instruments GmbH & Co. KG Ulrike Lindner
K153166 11/02/2015 Fusion Bx FOCAL HEALTCARE INC. MAHAM ANSARI
K153259 11/10/2015 VasoStat Hemostasis Device FORGE MEDICAL, INC. Timothy Clark
K153449 11/30/2015 2008K2 Hemodialysis Machine FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K153242 11/09/2015 Frontier Medical Devices In-Line Orthopedic Cable Cerclage System FRONTIER MEDICAL DEVICES, INC. ALLISON K. ROGERS
K153206 11/05/2015 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM MEDICAL SYSTEM U.S.A., INC. Shraddha More
K153361 11/20/2015 Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN
K153325 11/19/2015 Gradia Plus GC America Inc. Mark Heiss
K153231 11/09/2015 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC AMERICA, INC. Mark Heiss
K153253 11/10/2015 GC Reline II GC AMERICA, INC. MARK HEISS
K153429 11/25/2015 SmartView 3D Option GE HANGWEI MEDICAL SYSTEM CO., LTD LV RUI
K153402 11/24/2015 Discovery NM/CT 670 CZT GE HEALTHCARE GEORGE MASHOUR
K153355 11/20/2015 Xeleris 4.0 Processing and Review Workstation GE HEALTHCARE EFRAT HARTOG-DAVID
K153203 11/04/2015 Navigation Instruments GLOBUS MEDICAL INC. Kelly J Baker
K153368 11/23/2015 Radiance V3 GMV SOLUCIONES GLOBALES INTERNET S.A.U. CARLOS ILLANA
K153388 11/23/2015 IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IM GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. BANGFU SUN
K153255 11/10/2015 Aero Chrome* Breathable Performance Surgical Gown Halyard Health, Inc. DAVID M. LEE
K153304 11/16/2015 Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc. Marysa Loustalot
K153214 11/05/2015 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K153289 11/13/2015 HEALTHMYNE HEALTHMYNE, INC SIGRID SCHOEPEL
K153332 11/19/2015 ETIII SA Fixture System (O3.2mm) HIOSSEN INC. PATRICK LIM
K153421 11/25/2015 HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS HITACHI ALOKA MEDICAL AMERICA, INC. ANGELA VAN ARSDALE
K153219 11/05/2015 ProFlu+ Assay HOLOGIC, INC. RON DOMINGO
K153223 11/06/2015 ProParaFlu+ Assay HOLOGIC, INC. RON DOMINGO
K153296 11/13/2015 MEDINAUT Kyphoplasty System IMEDICOM Co., Ltd. Bonggu Ha
K153348 11/20/2015 JAZZ LOCK Implanet, S.A. Regis Le Couedic
K153389 11/23/2015 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) IN LIGHT WELLNESS SYSTEMS, INC. JANE MELONE
K153204 11/04/2015 In2Bones Kirschner wire IN2BONES SAS Morgane Grenier
K153395 11/24/2015 OS2-C Compression Staple IN2BONES SAS MORGANE GRENIER
K153350 11/20/2015 IBS Implant System INNOBIOSURG CO., LTD Bo-reum Yoo
K153153 11/02/2015 Reprocessed Electrophysiology Catheter INNOVATIVE HEALTH, LLC RAFAL CHUDZIK
K153150 11/02/2015 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 Inova Diagnostics, Inc. Gabriella Lakos
K153275 11/12/2015 Aingeal Activity System Intelesens, Ltd. Patricia Pepper
K153276 11/12/2015 da Vinci Xi Surgical System INTUITIVE SURGICAL, INC. Brandon Hansen
K153370 11/23/2015 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M, Incorporated Nancy Giezen
K153199 11/02/2015 Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack KCI USA, INC. MARGARET MARSH
K153364 11/20/2015 Kerecis SecureMesh Kerecis Limited Gudmundur Fertram Sigurjonsson
K153439 11/27/2015 PathLoc-C Posterior Cervical Fixation System L&K BIOMED CO., LTD. Yerim An
K153399 11/24/2015 LightStim Professional LED Bed LED Intellectual Properties LLC Steve Marchese
K153400 11/24/2015 ProLift Expandable System LIFE SPINE, INC. RANDY LEWIS
K153194 11/04/2015 VASOVIEW HemoPro Endoscopic Vessel Harvesting System MAQUET CARDIOVASCULAR, LLC MARK DINGER
K153225 11/06/2015 Masimo Root Monitoring System and Accessories Masimo Corporation Marguerite Thomlinson
K153427 11/25/2015 Volpara Imaging Software Matakina Technology LTD Ralph Highnam
K153329 11/19/2015 MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis MED-TECH WATER SYSTEMS INC BRIAN C KIM
K153273 11/12/2015 MySpine Pedicle Screw Placement Guides - LP Medacta International SA Michael G Loiterman
K153238 11/09/2015 Dignity Dual Port Medcomp ( Medical Components) Beth Ann Giammaruti
K153246 11/09/2015 PTFE Super Sheath Introducer 2.1 MEDCOMP (MEDICAL COMPONENTS, INC.) COURTNEY NIX
K153264 11/12/2015 EasyPass Guidewire MEDI-GLOBE CORPORATION SCOTT KARLER
K153331 11/19/2015 SafeCT-29 MEDIC VISION IMAGING SOLUTIONS EYAL AHARON
K153441 11/27/2015 VibraPEP Medica Holdings, LLC George Reed
K153168 11/02/2015 Bi-Blade Vitrectomy Cutter MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES Brenda Balletto
K153169 11/02/2015 PASS OCT Patient Specific Rods MEDICREA INTERNATIONAL Davis Ryan
K153413 11/25/2015 PASS LP Spinal System MEDICREA INTERNATIONAL S.A. DAVID RYAN
K153247 11/09/2015 Fusion Compact Navigation System MEDTRONIC NAVIGATION, INC. RISHI SINHA
K153373 11/23/2015 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device Medtronic Sofamor Danek Sneh Pingle
K153438 11/27/2015 PERIMETER C (Titanium) Spinal System MEDTRONIC SOFAMOR DANEK USA, INC MICHAEL SCOTT
K153442 11/27/2015 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATIO Medtronic Sofamor Danek USA, Inc. Lila Joe
K153160 11/02/2015 AVIVO Mobile Patient Management (MPM) System MEDTRONIC, INC. CHERYL L. SWANSON
K153337 11/19/2015 Corvocet Biopsy System MERIT MEDICAL SYSTEMS, INC. Ileana Davis
K153285 11/12/2015 EMS-200 META SYSTEMS CO., LTD. RAY JEON
K153283 11/12/2015 VivoSight Dx Topical OCT System Michelson Diagnostics Ltd Martin Johns
K153450 11/30/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K153426 11/25/2015 Ox-Imager CS MODULATED IMAGING, INC. DAVID CUCCIA
K153228 11/06/2015 NMI Port, NMI Port II NAVILYST MEDICAL, INC. Robin Fuller
K153262 11/10/2015 PUREtraceÖ NEMO HEALTHCARE BV Aron Wierts
K153182 11/03/2015 SELF- COMPRESSIVE SCREW NEOSTEO JD WEBB
K153265 11/12/2015 New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated New Deantronics Taiwan, Ltd. Jane Liu
K153453 11/30/2015 Inertia Pedicle Screw and Deformity Correxxion System NEXXT SPINE LLC ANDY ELSBURY
K153251 11/10/2015 Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. CHARLES SHEN
K153162 11/02/2015 Hypocore NOVOCOR MEDICAL SYSTEMS, INC TAMMY CARREA
K153419 11/25/2015 NuVasive CoRoent Thoracolumbar System NUVASIVE, INCORPORATED Michelle Cheung
K153336 11/19/2015 VuePoint OCT System NUVASIVE, INCORPORATED Kelsey Lien
K153437 11/27/2015 Apex Revision Knee System OMNILIFE SCIENCE CHRISTINA ROVALDI
K153267 11/12/2015 ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash ORIGIO A/S Tove Kjaer
K153237 11/09/2015 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K153216 11/05/2015 Alpine Cemented Hip System ORTHO DEVELOPMENT CORPORATION Drew Weaver
K153374 11/23/2015 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System ORTHOCARE RAJEEV CHHABRA
K153317 11/18/2015 HEMASORBPLUS Resorbable Hemostatic Bone Putty ORTHOCON, INC. HOWARD L. SCHRAYER
K153428 11/25/2015 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System ORTHOFIX INC. Jacki Geren
K153233 11/09/2015 Galaxy UNYCO System ORTHOFIX SRL GIANLUCA RICADONA
K153306 11/16/2015 Imbibe Needle ORTHOVITA, INC. LYNN LUNDY
K153434 11/27/2015 Pall-Aquasafe Water Filter PALL INTERNATIONAL, SARL KAREN D PETERSON-DOYLE
K153422 11/25/2015 Panpac Disposable Pessary Fitting Set Panpac Medical Corporation YEN-MING PAN
K153302 11/13/2015 coflex-IF PARADIGM SPINE, LLC Marc Viscogliosi
K153378 11/23/2015 Monster BITE Screw System PARAGON 28 Frank S. Bono
K153444 11/27/2015 Philips Multislice CT System with Low Dose CT Lung Cancer PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. Michael Chilbert
K153318 11/18/2015 Philips Eleva Workspot with SkyFlow Philips Medical Systems DMC GmbH MING XIAO
K153324 11/18/2015 Ingenia 1.5T and Ingenia 1.5T S R5.2 PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. Henrie Daniels
K153409 11/25/2015 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) PROTECT U GUARD, LLC Brent W. Laartz
K153249 11/09/2015 Pulpdent Solo Flowable Composite with MCP Pulpdent Corporation Kenneth J Berk
K153351 11/20/2015 Quantib Brain 1 QUANTIB BV FLOOR VAN LEEUWEN
K153435 11/27/2015 Direct HDL Cholesterol (HDL) Randox Laboratories Ltd Pauline Armstrong
K153163 11/02/2015 ReGrasp Rehabtronics Inc. Mike Pearson
K153272 11/12/2015 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set RELIEVANT MEDSYSTEMS ADAM SAVAKUS
K153250 11/09/2015 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System RENOVIS SURGICAL TECHNOLOGIES ANTHONY DEBENEDICTIS
K153307 11/16/2015 HS SutureTape RIVERPOINT MEDICAL Edwin Anderson
K153301 11/13/2015 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II ROCHE DIAGNOSTICS EDIE EADS
DEN150053 11/18/2015 FETAL PILLOW SAFE OBSTETRIC SYSTEMS LTD RAJIV VARMA
K153401 11/24/2015 GR40CW SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K153408 11/25/2015 HM70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD Jiyoung Kim
K153189 11/03/2015 Beacon Tissue Marker (SE) SCION MEDICAL TECHNOLOGIES, LLC LOUIS LI
K153201 11/04/2015 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System SD BIOSENSOR Yeon Park
K153212 11/05/2015 Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc. JENNIFER DOWNING
K153188 11/03/2015 Caremed patient cable and leadwires SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. XINLIN XIAO
K153184 11/03/2015 Caremed Reusable & Disposable SPO2 Sensors SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. XINLIN XIAO
K153448 11/30/2015 Passport Series Patient Monitors (Including Passport 8, Passport 12) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BAI YANHONG
K153291 11/13/2015 SICAT OPTISLEEP SICAT GMBH & CO. KG MANFRED BREUER
K153365 11/20/2015 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K153244 11/09/2015 Cios Fusion SIEMENS MEDICAL SOLUTIONS USA, INC. DARREN A. DORMAN
K153232 11/09/2015 Cios Select SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K153447 11/27/2015 MAGNETOM Spectra SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K153346 11/20/2015 syngo Application Software VD11 Siemens Medical Solutions USA, Inc. Patricia D Jones
K153220 11/06/2015 syngo.CT Single Source Dual Energy (Twin Beam) Siemens Medical Solutions USA, Inc. Kimberly Mangum
K153360 11/20/2015 ADMIRE SIEMENS MEDICAL SOLUTIONS, INC. JOHN URTZ
K153343 11/19/2015 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit SIEMENS MEDICAL SOLUTIONS, INC. JOHN URTZ
K153208 11/05/2015 Internal Joint Stabilizer - Elbow SKELETAL DYNAMICS, LLC Ana M Escagedo
K153209 11/05/2015 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply SMITH & NEPHEW MEDICAL LTD. LAURA REYNOLDS
K153274 11/12/2015 Med-Tainer Single Deposit Container Snyder Industries, Inc. Herbert H Spann
K153239 11/09/2015 LSFG-NAVI Softcare Co., Ltd Noriyoshi Takahashi
K153157 11/02/2015 Sonendo Gentle Wave System SONENDO, INC. DAN W. MILLER
K153391 11/24/2015 Sophono Bone Conduction Systems (S) Configuration and (M) Configuration SOPHONO INC. Rozanne Paciej
K153367 11/23/2015 S698 Symbioz flow SOPRO - ACTEON GROUP Philippe BOYER
K153352 11/20/2015 Vertu« & Vertu« Ti-Bond and Crystal« & Crystal« Ti-Bond Cervical Interbody System Spinal Elements Inc. Cecilia Silva
K153356 11/20/2015 Spine Innovation Interbody System Spine Innovation LLC Jude Paganelli
K153222 11/06/2015 Leva Spacer System SPINE WAVE, INC. Gail Yaeker-Daunis
K153386 11/23/2015 Perla Posterior Cervico-Thoracic Fixation system SPINEART FRANCK PENNESI
K153323 11/18/2015 Palisade Pedicular Fixation System SPINEOLOGY, INC. JACQUELINE A HAUGE
K153358 11/20/2015 Standard Clamp STANDARD BARIATRICS ALISON SATHE
K153173 11/03/2015 MOR Implant System STERNGOLD DENTAL, LLC MARIA RAO
K153248 11/09/2015 PEEK Customized Cranial Implant STRYKER Jonathan Schell
K153240 11/09/2015 Styrker OrthoMap Express Knee System STRYKER CORPORATE Becky Ditty
K153407 11/25/2015 Stryker Neptune 3 Waste Management System STRYKER CORPORATION KIM WIERSEMA
K153379 11/23/2015 AxSOS 3Ti Stryker GmbH Saad Attiyah
K153377 11/23/2015 Hoffmann LRF (Limb Reconstruction Frame) System Stryker GmbH Paul Nelson
K153345 11/19/2015 Stryker Orthopaedics Hip Systems Labeling Update STRYKER ORTHOPAEDICS MARGARET KLIPPEL
K153415 11/25/2015 Reprocessed Stryker External Fixation Devices STRYKER SUSTAINABILITY SOLUTIONS KELLI DRYER
K153154 11/02/2015 Asnis JFX System Stryker Trauma AG Garry T. Hayeck
K153258 11/10/2015 Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars Surgical Instrument Service and Savings (dba Medline ReNewal Brandi J Panteleon
K153281 11/12/2015 BrightMatter Guide with Surface Trace Registration SYNAPTIVE MEDICAL INC. Cameron Piron
K153284 11/12/2015 Synaptive ImageDrive Pro SYNAPTIVE MEDICAL INC. Cameron Piron
K153311 11/17/2015 Flexitouch System TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL) Thomas A Dold
K153299 11/13/2015 Tenex Health TX System TENEX HEALTH, INC. GLORIA PENDERGRASS
K153376 11/23/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation Bryan Hann
K153213 11/05/2015 Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A Brown
K153202 11/04/2015 iMESH Tacker THD LAP Einat Duvdevany
K153230 11/06/2015 ShefaBone SCPC Resorbable Bone Graft THE IMPLANTECH INC./SHEFABONE AHMED EL-GHANNAM
K153452 11/30/2015 Salto XT, Salto Talaris Tornier SAS S?verine BONNETON
K153263 11/10/2015 Aquilion Lightning, TSX-035A/4 and /5, V7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K153417 11/25/2015 ST AIA-PACK PROG III Calibrator Set TOSOH BIOSCIENCE, INC. ROBERT L. WICK
K153310 11/17/2015 Klassic Knee System TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K153338 11/19/2015 Tiger Cannulated Screw System Trilliant Surgical, LTD Jon Olson
K153363 11/20/2015 Red2Green Reusable Sharps Container TRIUMVIRATE ENVIRONMENTAL, INC. STEVE TODISCO
K153392 11/24/2015 STERIZONE VP4 Sterilizer TS03 INC Nathalie Racette
K153180 11/03/2015 Tyber Medical MST Trauma Screw TYBER MEDICAL LLC Mark F. Schenk
K153362 11/20/2015 AquaShield system CO2, AquaShield system-PENTAX UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
K153384 11/23/2015 Low Potassium Dextran Solution with Tris Diluent United Therapeutics Corporation Rita Lee
K153156 11/02/2015 eCareManager 4.0.1 VISICU, INC. Daniel R. Plonski
K153177 11/03/2015 Admira Fusion Flow VOCO GMBH MANFRED THOMAS PLAUMANN
K153369 11/23/2015 SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz VOLCANO CORPORATION Brian Park
K153290 11/13/2015 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium WILLIAM A. COOK AUSTRALIA PTY LTD Gordana Pozvek
K153159 11/02/2015 Vinyl patient examination glove, Powder Free XINGYUAN PLASTIC PRODUCTS CO., LTD. QIWEI XING
K153334 11/19/2015 Oral-B 5% Sodium Fluoride Varnish YOUNG DENTAL MANUFACTURING CO 1, LLC. Sarah Moore
K153404 11/24/2015 Zavation Spinal System ZAVATION, LLC Lawrence Walker
K153226 11/06/2015 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit ZOLL CIRCULATION, INC. SAM NANAVATI
K153193 11/03/2015 Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) ZYNO MEDICAL LLC Mei Zhang


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