FDA 510(k) Decisions During February, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K151933 12/10/2015 BRX PRO Bruxism Guard 12TH MAN TECHNOLOGIES, INC. ALEX STENZLER
DEN140044 02/19/2015 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) 23andMe Kathy Hibbs
K143058 02/13/2015 PuraDerm Gel 3-D Matrix, Inc. Lisa Spirio
K152060 12/01/2015 3M Attest Rapid Readout Biological Indicator 1295 3M COMPANY MATT MORTENSEN
K152078 12/04/2015 Implant Studio 2015 3Shape Medical A/S Hanne Nielsen
K152155 12/17/2015 ARCHITECT 2nd Generation Testosterone Abbott Laboratories Regina Xavier Kumar
K152442 12/17/2015 Freestyle Freedom Blood Glucose Monitoring Sytem ABBOTT LABORATORIES Sai Sriharshada Tatavarty
K152721 12/08/2015 Cytal Wound Matrix ACELL, INC THOMAS GILBERT
K143276 02/05/2015 Acumed Small Bone IM Nail System Acumed, LLC Nathan Wolf
K152417 12/01/2015 Adler MicroMed Laser Surgery Fibers ADLER MICROMED INC. BRIAN CHANDLER
K150233 02/26/2015 NIOX VERO Airway Inflammation Monitor AEROCRINE AB Kathleen Rickard
K141694 02/24/2015 AESCULAP ORTHOPILOT NEXT GENERATION AESCULAP IMPLANT SYSTEMS, LLC JULIE TOM WING
K150062 02/09/2015 Excia Total Hip System AESCULAP IMPLANT SYSTEMS, LLC JULIE TOM WING
K152639 12/11/2015 DR 600 AGFA HEALTHCARE N.V. Koren Vervoort
K150930 12/18/2015 Deployable Oxygen Generation System-Smaill (DOGS-S) AirSep Corporation Peter Weisenborn
K141123 02/27/2015 ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM ALLIANCE PARTNERS, LLC. TIM LOHNES
K141945 02/03/2015 ECHOSTAR COMFORT 1.5T MRI ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K152968 12/30/2015 Arsenal Spinal Fixation System ALPHATEC SPINE, INC RENEE MURPHY
K143337 02/17/2015 CONELOG Titanium base CAD/CAM ALTATEC GMBH DENNIS PAPPAS
K152460 12/22/2015 Rectangular Corpectomy Cage Amendia, Inc. Bruce Hooper
K152291 12/17/2015 Sterisheet Sterilization Wrap ANDERSEN STERILIZERS, INC. WILLIAM K ANDERSEN
K150833 12/04/2015 iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System ANDON HEALTH CO.,LTD Yi Liu
K151168 12/22/2015 Nexodyn AOS Wound Care Solution APR Applied Pharma Research SA Giorgio Reiner
K141559 02/27/2015 V-GUIDE FOR VENTRICULOSTOMIES ARC SURGICAL LLC. CRAIG PAGAN
K153313 12/11/2015 SpeedLock Knotless Fixation System ARTHROCARE CORPORATION LAURA KASPEROWICZ
K153344 12/17/2015 Asahi REXEED-S Series Dialyzer Asahi Kasei Medical Co., Ltd. Hidenobu Nakazawa
K152047 12/23/2015 INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid ASCENSION ORTHOPEDICS WILLIAM GARZON
K152153 12/11/2015 MicroSpot Handpiece ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K152732 12/10/2015 AOS Small Fragment Plating System AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) Mark Steinhauer
K150787 12/02/2015 Universal Spike B. Braun Medical Inc. Tracy Maddock
K143632 02/13/2015 Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens Bausch & Lomb Incorporated Jessica Burger
K153158 12/28/2015 Solution Administration Sets with 0.2 Micron Filter BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K152852 12/22/2015 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) BAYER HEALTHCARE, LLC William R Walsh
K153210 12/21/2015 Defibrillator Analyzer Variable Load BC GROUP INTERNATIONAL, INC Mel Roche
K141468 02/27/2015 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) BD Biosciences Terrance Thiel
K142985 02/26/2015 UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator BECKMAN COULTER, INC. Eimear Carr
K150815 12/17/2015 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit Becton, Dickinson and Company Catherine(Katie) Bessette
K153257 12/11/2015 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY MATTHEW TRACHTENBERG
K142888 02/20/2015 Fingertip Pulse Oximeter BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Lei Chen
K143150 02/05/2015 CO2 monitoring line with and without in-line filter BESMED HEALTH BUSINESS CORP. WINNIE CHUNG
K150300 12/11/2015 Liquichek Cardiac Markers Plus Control LT Bio-Rad Laboratories Elizabeth Platt
K151321 12/09/2015 D-100 HbA1c, D-100 HbA1c Calibrator Pack Bio-Rad Laboratories, Inc. Jackie Buckley
K151876 12/30/2015 Bio2 Fusion Implant System Bio2 Technologies, Inc Janet Krevolin
K152157 12/11/2015 LC Bead LUMI BIOCOMPATIBLES UK LTD April Kent
K151295 12/01/2015 Biodenta Customized Abutment - Titanium BIODENTA SWISS AG DAVID ELIER
K143005 02/19/2015 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 BioFire Diagnostics, LLC Kristen Kanack
K143080 02/17/2015 FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System BioFire Diagnostics, LLC Kristen Kanack
K141798 02/19/2015 SYPHER SPACER SYSTEM BIOGENNIX, LLC MEREDITH MAY, MS, RAC
K152326 12/10/2015 Biomet Microfixation OmniMax MMF System BIOMET MICROFIXATION LAUREN JASPER
K142823 02/25/2015 Biomet Microfixation Thoracic Fixation System BIOMET MICROFIXATION Lauren Jasper
K142882 02/10/2015 G7 Freedom and Offset Liners, Freedom Head, Size 32 Biomet, Inc. Becky Earl
K143192 02/12/2015 Vanguard 360 Revision Knee System Biomet, Inc. Jason Heckaman
K142432 02/20/2015 StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit BIONESS, INC. Robert Schulz, RAC
K150722 12/02/2015 EnFocus 2300, EnFocus 4400 BIOPTIGEN, INC. Tammy B Carrea
K152889 12/30/2015 SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS BIORENEW LABS, LLC JON DAVID
K143705 02/20/2015 NeedleCam HD Visualization System BIOVISION TECHNOLOGIES, LLC DAVID SANSO
K150997 12/22/2015 RUBY STAR BISON MEDICAL CO., LTD SUN-WOO LEE
K153088 12/11/2015 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System BOSTON SCIENTIFIC CORPORATION ASHLEY SANTOS
K151840 12/16/2015 Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation Nikki M Wahlberg
K152401 12/04/2015 Stingray LP Catheter BOSTON SCIENTIFIC CORPORATION KURTIS HUNSBERGER
K140828 02/04/2015 NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE BRAINREADER APS METTE MUNCH
K141285 02/19/2015 BUSSE EXTENSION SET BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K153298 12/10/2015 AccuCath Intravascular Catheter C.R. Bard, Inc. Casey Coombs
K152554 12/14/2015 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc. Kerrie Hamblin
K150585 12/31/2015 Ascent 3D CAO GROUP, INC. Robert K Larsen
K150769 12/14/2015 Cardinal Health Trochanteric IM Nail System Cardinal Health Tatyana Bogdan
K151445 12/21/2015 Cardinal Health Sterilization Wrap CARDINAL HEALTH 200, LLC MEGAN MIDDAUGH
K142858 02/09/2015 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) Careplus (M) SDN BHD Lim Kwee Shyan
K153492 12/24/2015 CareView 1800L CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. Leilei Li
K152467 12/09/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L. WAGNER
K151255 12/30/2015 Navigator Aesthetic Delivery System CARTICEPT MEDICAL INC CARRIBETH RAMEY
K152162 12/24/2015 Myray- HYPERION X5 CEFLA S.C. Silvia Sansavini
K153148 12/01/2015 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) YON YU
K152211 12/01/2015 PCT System CENTINEL SPINE, INC. JESSICA STAUB
K151226 12/03/2015 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) CEPHEID Kerry J Flom
K143302 02/12/2015 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 CEPHEID KERRY J FLOM
K151672 12/21/2015 Cerner CareAware Event Management CERNER CORPORATION SHELLEY S. LOOBY
K143013 12/11/2015 Spinal Inner Fixation System Changzhou Dingjian Medical Appliance Co., Ltd Li Quinsong
K151062 12/17/2015 WASTON Metallic Intramedullary Nail System CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD Jack Lu
K153085 12/21/2015 Q Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. Qifei Liu
K152515 12/18/2015 TOMCAT Cervical Spinal System CHOICE SPINE, LP Kim Finch
K152146 12/08/2015 High Speed Handpieces and Accessories CODENT TECHNICAL INDUSTRY CO., LTD. Chin-Ting Wen
K151126 12/18/2015 Foresight Intracardiac Echocardiography (ICE) System Colibri Technologies Inc. SAM MOSTAFAVI
K152243 12/09/2015 One Coat 7 Universal Coltene/Whaledent AG Silke Wallaschek
K153499 12/18/2015 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension ConMed Corporation Dionne Sanders
K152860 12/29/2015 HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL CONMED CORPORATION LISA ANDERSON
K142716 02/10/2015 VCARE CONMED CORPORATION ANNA D'LIMA
K150668 12/09/2015 Biodesign Enterocutaneous Fistula Plug COOK BIOTECH INCORPRATED Perry W Guinn
K150748 12/18/2015 Flexipet Denuding Pipette, Flexipet Manipulation Pipette COOK INCORPORATED NAOMI FUNKHOUSER
K150931 12/18/2015 MReye Embolization Coils Cook Incorporated Nozomi Yagi
K150964 12/18/2015 MReye Flipper Detachable Embolization Coil and Delivery System Cook Incorporated Nozomi Yagi
K143415 02/26/2015 Air Bubble Based Infuser (ABBI) CooperSurgical, Inc James Keller
K153092 12/21/2015 Ally Uterine Positioning System CooperSurgical, Inc. Roaida Johnson
K141382 02/10/2015 BIOS KING BIOCELLULOSE FILM CORELEADER BIOTECH CO., LTD. YA-WEN KUO
K152284 12/04/2015 COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS COTTON HIGH TECH S.L. Anna Garcia
K151279 12/16/2015 Counter OTC TENS Device, Model CSD-737Z COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Jiang Eagle
K143088 02/25/2015 GastriSail Gastric Positioning System COVIDIEN Debbie Peacock
K142128 02/23/2015 KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR COVIDIEN SHANNON GREEN
K151381 12/11/2015 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye Covidien Danielle Mueller
K142296 02/24/2015 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula Covidien Danielle Mueller
K142298 02/13/2015 Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff Covidien Kelsey Lee
K152586 12/30/2015 Beacon Fine Needle Fiducial System Covidien LLC RACHEL SILVA
K152306 12/11/2015 MotoBand? CP Implant System CROSSROADS EXTREMITY SYSTEMS, LLC VERNON HARTDEGEN
K151896 12/07/2015 Houdini Catheter Cruzar Medsystems, Inc. Tom Kramer
K151158 12/10/2015 ALP VasQcare Take Home System Currie Medical Specialties, Inc. Owen J Bry
K143105 02/23/2015 Picosure Workstation CYNOSURE, INC. Kelli McMillan
K143092 02/11/2015 Tensyn Plug DALLEN MEDICAL, INC. Al Memmolo
K142881 02/13/2015 DMRC Dual Cure Orthodontic Band Cement DANVILLE MATERIALS, LLC. Dong Hua
K140575 02/03/2015 ENGSTROM CARESTATION, ENGSTROM PRO DATEX-OHMEDA, INC. TRISHIA DWYER
K142880 02/04/2015 DMRC Light Cure Orthodontic Adhesive System Daville Materials LLC Dong Hua
K151496 12/15/2015 Latitude-C Cervical Interbody Spacer System Degen Medical Craig Black
K152767 12/14/2015 OTC12D AUTO RADIOGRAPHIC SYSTEM DEL MEDICAL, INC. JOHN HARTZELL
K152322 12/16/2015 Resolve 2.0 DENALI CORPORATION Jan G Stannard
K142987 02/11/2015 DD Bio Z, DD Bio ZX(square), DD BioZX(square) color DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) Gerhard de Boer
K151926 12/14/2015 QuickRay HD Intraoral Sensor DENTERPRISE INTERNATIONAL, INC. CLAUDE BERTHOIN
K142313 12/10/2015 OneQ-SL Implant System DENTIS CO. LTD. Jeong Seop Keun
K142178 02/26/2015 PROROOT MTA WHITE, PROROOT MTA GRAY DENTSPLY INTERNATIONAL INC. HELEN LEWIS
K140881 02/13/2015 DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS DEPUY (IRELAND) NANCY FRIDDLE
K143362 02/03/2015 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products John Siegel
K152859 12/03/2015 Portable X-ray System (Model: MINIX-V / MINIX-S) DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) YOUNGBAE KWON
K142228 02/09/2015 Heated Eye Pad Digital Heat Corporation John Devine
DEN150010 12/08/2015 Dignitana AB DigniCap System DIGNITANA AB JAN RICHARDSSON
K143127 02/13/2015 CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style DISPO-MED (MALAYSIA) SDN BHD NC LEOW
K141410 02/19/2015 ORAGENE DX OGD-500.001 DNA GENOTEK, INC. DAN FULLERTON
K152508 12/31/2015 Ageless Health Medical Digital Thermometer DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD VICTOR WAN
K152172 12/14/2015 Econsole1 DRTECH CORPORATION CHOUL-WOO SHIN
K140990 02/27/2015 EMS PIEZON 707 BIK AND PIEZON 707 BIK LED E.M.S. ELECTRO MEDICAL SYSTEMS S.A. TINA WU
K142064 02/13/2015 GALILEO NT EB NEURO, S.P.A. ALLISON SCOTT, RAC
K150190 02/26/2015 IntraTemp Solution Warmer Ecolab Inc. Michelle Nivala
K142511 02/20/2015 U50 Diagnostic Ultrasound System EDAN INSTRUMENTS, INC. CHERRY SUN
K140579 02/06/2015 ULTRASONIC POCKET DOPPLER EDAN INSTRUMENTS, INC. QUEENA CHEN
K151878 12/01/2015 Video Colposcope EDAN INSTRUMENTS, INC. Queena Chen
K142576 02/26/2015 Spinal System EISERTECH, LLC Lukas Eisermann
K153011 12/11/2015 iViewDose R1.0 Elekta Limited Maurice Paine
K151686 12/30/2015 HumanPen Ergo II ELI LILLY AND COMPANY, INC. CHRISTINE A. PHILLIPS
K152370 12/22/2015 PRECICE Trauma Nail System Ellipse Technologies Incorporated John McIntyre
K133019 02/20/2015 FIBERION OPHTHALMIC ENDOLASER PROBE EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM MEHMET MELEK
K152182 12/10/2015 Fuse Gastroscopy System ENDOCHOICE INC. DANIEL HOEFER
K151567 12/23/2015 ENDOPLUS hand-held laparoscopic instruments ENDOPLUS Matthew Gudeman
DEN150005 12/18/2015 Newa Skin Therapy System EndyMed Medical Ltd. Yoram Levy
K150020 02/25/2015 Irritrol, EDS Combo-Rinse ESSENTIAL DENTAL SYSTESM, INC. JEFFREY WAN
K132868 02/20/2015 CARRICELL ETEX CORPORATION MICHAEL STRUNK, PHD.
K141492 02/06/2015 ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) EUROSETS S.R.L. MARIO GENNARI
K143576 02/27/2015 Exactech Ambassador EXACTECH, INC. DAWN DAVISSON
K143402 02/04/2015 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL LLC Brian Smekal
K150166 02/23/2015 Extremity Medical Suture Anchor EXTREMITY MEDICAL LLC Brian Smekal
K141401 02/20/2015 EASY OUT FEET FOR LIFE PODIATRY CENTER MICHAEL HORWITZ
K141666 02/03/2015 FERTILIGENT SLOW RELEASE IUI CATHETER KIT FERTILIGENT, LTD BABACAR DIOUF
K152406 12/23/2015 SalivaMAX FORWARD SCIENCE LLC Brian Pikkula
K150708 12/10/2015 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K143228 02/26/2015 Ancora LLC Interbody Fusion Device FRONTIER MEDICAL DEVICES, INC. ERIC SEABORG
K153483 12/15/2015 Balloon controller PB-30 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Aaron Ge
K134046 02/12/2015 FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR FUKUDA DENSHI USA, INC. DOUG BLAKELY
K152722 12/08/2015 neoV980 & neoV1470 Diode Lasers G.N.S NEO LASER LTD. GIL SHAPIRA
K150408 12/14/2015 V-STEADY, V-FAST G21 S.R.L. MAURIZIO FORONI
K152528 12/02/2015 Attachable Cath Lab Hemostasis Valve GALT MEDICAL CORP. DAVID DERRICK
K142472 02/10/2015 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems GE Healthcare Tracey Ortiz
K143251 02/04/2015 SIGNA Creator, SIGNA Explorer GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) GLEN SABIN
K143270 02/18/2015 Optima XR646 GE HUALUN MEDICAL SYSTEMS CO. LTD Kenny Ma
K151063 12/15/2015 Monitor B40 GE MEDICAL SYSTEMS CHINA CO., LTD. Sun YanLi
K141963 02/05/2015 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K150354 12/10/2015 PAPAYA 3D Plus GENORAY CO., LTD. Kyoung-hwa Kim
K150782 12/14/2015 AbStats Gateway GI Logic Inc James Beeton
K142498 02/26/2015 MAGNIFY and MAGNIFY-S Spacers GLOBUS MEDICAL INC. KELLY J BAKER
K150179 02/25/2015 CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K150024 02/20/2015 Bissinger Monopolar Cables GUENTER BISSINGER MEDIZINTECHNIK GMBH Matthias Bissinger
K152219 12/17/2015 PK AIM GYRUS ACMI INC NEIL KELLY
K150966 12/04/2015 HMB32 HAEMOPHARM BIOFLUIDS SRL GIUSEPPE TOMASINI
K141429 02/23/2015 SORRENTO BONE GRAFT SUBSTITUTE HAIDER BIOLOGICS, LLC GUSTAVO R PRADO
K143183 02/17/2015 Maxima XTEND Handpiece Maintenance System HANDPIECE HEADQUARTERS Timothy Ropchan
K142476 02/17/2015 Master Caution Device MCD HealthWatch Ltd. Yoram Levy
K142731 02/27/2015 HEARTWAY Electrically Powered Wheelchairs HEARTWAY Medical Products Co., Ltd. Dr. Ke-Min Jen
K151127 12/08/2015 higi Station higi SH LLC Colin Hill
K153223 12/09/2015 ProParaFlu+ Assay HOLOGIC, INC. RON DOMINGO
K151133 12/09/2015 PENTRA XLR HORIBA ABX SAS Caroline Ferrer
K143015 02/25/2015 Hospira Primary Sets Hospira, Inc. Anju Kurian
K143431 02/20/2015 Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) i-codi Co., Ltd Yoo Hwan Park
K151025 12/29/2015 iHearTest IHEAR MEDICAL, INC. ANGELA LEE FOREMAN
K143500 02/06/2015 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Immunalysis Corporation Joseph Ginete
K141803 02/12/2015 IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY Immunalysis Corporation joseph Ginete
K143323 02/26/2015 OS2-V Varisation Staple IN2Bones SAS MORGANE GRENIER
K143563 02/03/2015 Infusion Aspiration Catheter System Inari Medical, Inc. Eben Gordon
K142244 02/06/2015 CLEO PATIENT MONITOR INFINIUM MEDICAL SULEYMAN BILGUTAY
K152491 12/17/2015 MoMe Software Platform INFOBIONIC, INC. MATTHEW KING
K152996 12/17/2015 Molteno3 Glaucoma Implant INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) BRYAN WEINMANN
K141274 02/13/2015 QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS. INOVA DIAGNOSTICS, INC. Roger Albesa
K152875 12/21/2015 QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K141328 02/12/2015 QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K150174 02/26/2015 EMMA INRANGE SYSTEMS, INC. Christopher E Bossi
K150877 12/13/2015 ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory Co. Carol Marble
K150682 12/18/2015 CUSA Excel+ INTEGRA LIFESCIENCES CORP. JENNIFER SIEGEL
K142956 02/24/2015 NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit Integrated Healing Technologies Ian Baird
K141922 02/27/2015 IRIS INTELLIGENT RETINAL IMAGING SYSTEM INTELLIGENT RETINAL IMAGING SYSTEMS, LLC RYAN BOUCHARD
K151364 12/28/2015 Intellijoint HIP(tm) System INTELLIJOINT SURGICAL INC. BRANDON GINGRICH
K152112 12/29/2015 VisualEyes INTERACOUSTICS A/S ERIK NIELSEN
K152436 12/07/2015 Suntanning Lamps Interlectric Corporation Ken C. Frazier
K141087 02/12/2015 INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF INTERSURGICAL INCORPORATED MICHAEL ZALEWSKI
K152150 12/18/2015 V8 Balloon Aortic Valvuloplasty Catheter InterValve, Inc. Mark Ungs
K153126 12/09/2015 da Vinci Xi Hasson Cone INTUITIVE SURGICAL INC. VISHAL KANANI
K142937 02/24/2015 Endoscope Sterilization Tray INTUITIVE SURGICAL, INC. Nadine Nasr
K152330 12/23/2015 Expression MR400 MRI Patient Monitoring System INVIVO CORPORATION Rusty Kelly
K142374 02/13/2015 ivWatch Model 400 ivWatch, LLC Javier Garriz
K140045 02/18/2015 BODY COMPOSITION ANALYZER JAWON MEDICAL CO., LTD. W S PARK
K150009 02/25/2015 Baide Jiangsu Baide Medical Intrument Co.,Ltd. Mr.Kang Shui
K151074 12/22/2015 Magnetic Reasonance Imaging System JIANGSU MAGSPIN INSTRUMENT CO.,LTD LEO LI
K152323 12/14/2015 Disposable Infusion Needle, Safelock Disposable Infusion Needle JIANGYIN CAINA TECHNOLOGY CO., LTD JUN LU
K151991 12/11/2015 Safelock Disposable Blood Collection Set, Disposable Blood Collection Set JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K151481 12/21/2015 Sahara Stabilization System K2M, INC NANCY GIEZEN
K143350 02/25/2015 Nile Alternative Fixation K2M, Inc. Nancy Giezen
K152644 12/31/2015 KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 KEELER LIMITED IRINA PROUTSKI
K141738 02/17/2015 MEDEOR MATRIX WOUND DRESSING KENSEY NASH CORPORATION DBA DSM BIOMEDICAL BRIANNA JORDAN
K152441 12/04/2015 KIRO Set KIRO ROBOTICS S.L. Naiara Telleria
K143131 02/12/2015 Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile Kossan International Sdn. Bhd. Cho Sow Fong
K143439 02/27/2015 KATANA Zirconia KURARAY NORITAKE DENTAL, INC. Michio Takigawa
K142623 02/26/2015 PANAVIA SA Cement Plus Handmix KURARAY NORITAKE DENTAL, INC. Michio Takigawa
K150817 12/21/2015 Dario Blood Glucose Monitoring System LabStyle Innovations Ltd. TRACEY WIELINSKI
K150841 12/29/2015 Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant LACLEDE, INC. Michael Pellico
K151934 12/07/2015 ROI-C Titanium-Coated Implant System LDR SPINE USA JAMES WILSON
K152175 12/04/2015 Upcera Dental Zirconia Blank for Aesthetic Restoration LIAONING UPCERA CO.,LTD Charles Shen
K141246 02/22/2015 LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM LIFE SPINE, INC RANDY LEWIS
K141222 02/12/2015 NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM LIFE SPINE, INC RANDY LEWIS
K142991 02/17/2015 LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA LifeGlobal Group, LLC Michael D. Cecchi
K151611 12/14/2015 OneTouch Ultra Plus Flex Blood Glucose Monitoring System LIFESCAN EUROPE NIKI SKELLY
K151370 12/17/2015 UV Lamps for Indoor Tanning Devices LIGHT SOURCES, INC. EUGENE CZAKO
K142172 02/27/2015 LIGHTMED TRUSCAN 577 LIGHTMED CORP. ANGEL HSIEH
K132220 02/20/2015 PJ'S SERENITY LIMERICK, INC. PATRICIA KELLY
K141205 02/13/2015 LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 Lin-Zhi International, Inc. BERNICE LIN
K150934 12/21/2015 Powder Free Vinyl Patient Examination Glove (Non?-Sterile) LPL (HUI ZHOU) GLOVE LEE HONG CHONG
K152386 12/17/2015 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software LUMINEX MOLECULAR DIAGNOSTICS, INC. TINA IP
K143635 02/20/2015 KINETIS Total Knee System MAKO SURGICAL JONATHAN REEVES
K153461 12/11/2015 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm MAQUET CRITICAL CARE AB Mirva Boothe
K151814 12/21/2015 SERVO-U Ventilator System, SERVO-n Ventilator System MAQUET CRITICAL CARE AB MARIA VON BAHR
K150831 12/22/2015 Cellvizio 100 Series System with Confocal Miniprobes MAUNA KEA TECHNOLOGIES Sophie Rehault
K143191 02/20/2015 IntelliSense Drill McGinley Innovations Joseph McGinley
K152201 12/30/2015 MedActive Oral Gel and Spray MedActive Oral Pharmaceuticals, LLC. Brian Walker
K142125 12/22/2015 New Medax Biopsy Systems MEDAX SRL UNIPERSONALE Stefano Cavalieri
K142167 02/20/2015 MEDENTIKA ABUTMENT SYSTEM MEDENTIKA GMBH LINDA SCHULZ
K141506 02/25/2015 MCC Para-Fix CARY BLAIR MEDIUM MEDICAL CHEMICAL CORPORATION KRIS J KONTIS
K143257 02/06/2015 KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System MEDICATECH USA George Makar
K150049 02/10/2015 PASS LP Spinal System MEDICREA INTERNATIONAL Audrey Vion
K142345 02/22/2015 Talos-C(HA) Cervical Intervertebral Body Fusion Devices MEDITECH SPINE, LLC JASON GROMEK
K143111 02/19/2015 Codman Certas Plus Programmable Valve; Codman Certas Toll Kit MEDOS INTERNATIONAL SARL Michelle Godin
K143711 12/02/2015 Reaxon Plus MEDOVENT GMBH THOMAS FREIER
K151359 12/18/2015 ROSA Brain MEDTECH S.A. MICHAEL CHRIST
K143569 02/12/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC GREGORY MASCHEK
K150178 02/11/2015 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC MICHAEL SCOTT
K143375 02/13/2015 CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments MEDTRONIC SOFAMOR DANEK USA, INC Becky Ronner
K143628 02/12/2015 Navigated Vertex Select Instruments MEDTRONIC SOFAMOR DANEK USA, INC Tejas Patel
K143471 02/06/2015 VERTEX Reconstruction System Medtronic Sofamor Danek USA, Inc Lee Grant
K153463 12/30/2015 CD HORIZON Spinal System, IPC POWEREASE System MEDTRONIC SOFAMOR DANEK USA, INC. Becky Ronner
K150200 02/25/2015 CD HORIZON Growth Rod Conversion Set MEDTRONIC SOFAMOR DANEK USA, INCORPORATED LEE GRANT
K152121 12/01/2015 NuVent EM Sinus Dilation System MEDTRONIC XOMED, INC. Gabriela Anchondo
K150246 02/18/2015 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc Becky Severson
K141587 02/18/2015 E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER MEGADYNE MEDICAL PRODUCTS, INC. RONDA MAGNESON
K142451 02/09/2015 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K151762 12/28/2015 PediatrOS RigidTack/FlexTack MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K152783 12/07/2015 Merit 20 mL Syringe Merit Medical Systems, Inc. CORY MARSH
K142597 02/19/2015 Vienna System MICK RADIO-NUCLEAR INSTRUMENTS, INC. Chuck Smith
K141516 02/05/2015 MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
K153071 12/23/2015 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Phuong Chau
K152001 12/10/2015 Sterile Repositionable Hemostasis Clipping Device Micro-Tech (Nanjing) CO.,Ltd. Becky Li
K153450 12/16/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K142119 02/27/2015 PROCOTYL L-O ACETABULAR SYSTEM MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K150870 12/21/2015 HydroPearl Microspheres, HydroPearl Microspheres MICROVENTION, INC. NAOMI GONG
K153053 12/29/2015 Traxcess Pro 14 Guidewire MICROVENTION, INC. SAPNA SINGH
K143222 12/11/2015 FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical Inc Heidi Frey
K151396 12/09/2015 MIVI Mi-AXUS Guide Catheter MIVI NEUROSCIENCE, INC Matthew Ogle
K150898 12/18/2015 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm MOLLER MEDICAL GMBH JULIANE DRAGON
K143457 02/19/2015 NeuroBlate System MONTERIS MEDICAL, INC. Brooke Ren
K142459 02/03/2015 Ebony PTA 0.014 RX Peripheral Dilatation Catheter NATEC MEDICAL LTD Xavier de Buchere
K153228 12/04/2015 NMI Port, NMI Port II NAVILYST MEDICAL, INC. Robin Fuller
K150005 02/19/2015 Checkpoint, Checkpoint Head & Neck NDI Medical, LLC Robert Rogers
K150145 02/06/2015 MD322C8 31.5 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD. SATORU KOTANI
K152857 12/17/2015 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps NEOMED, INC. TONY LAIR
K143135 02/20/2015 Spring Coil Guidewire NeoMetrics, Inc. Gene Champeau
K141316 02/13/2015 COGNISION EEG/EP SYSTEM NEURONETRIX SOLUTIONS CHERYL FISHER
K143230 02/25/2015 Palladian Lumbar Pedicle Screw System Neurostructures, Inc. Moti Altarac
K142774 02/18/2015 Polysmith Sleep System Neurotronics, Inc. David Pezet
K131335 02/03/2015 BWMINI EEG, BWMINIHST, BWMINI PSG NEUROVIRTUAL USA, INC. EDUARDO FARIA
K150729 12/29/2015 SpectraShield 9500 Surgical N95 Respirator Nexera Medical Inc. Paul Sallarulo
K150792 12/17/2015 Next Science Wound Gel NEXT SCIENCE, LLC MATTHEW MYNTTI
K152548 12/21/2015 AXI+LINE Proximal Bunion Correction System NEXTREMITY SOLUTIONS, Inc. Ryan Schlotterback
K150079 12/10/2015 Regenomer« Syringe, Regenomer« Plug, Regenomer« Block NIBEC CO, LTD YOON-JEONG PARK
K143678 02/06/2015 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory NINEPOINT MEDICAL, INC. SCOTT BLOOD
K143049 02/19/2015 LYNC intramedullary implant NOVASTEP Gilles Audic
K143229 02/06/2015 Nexis osteosynthesis compressive screws NOVASTEP Gilles Audic
K143146 02/06/2015 Nexis osteosynthesis snap-off screws NOVASTEP Gilles Audic
K152943 12/01/2015 NuVasive Foundation-LL System NUVASIVE INCORPORATED CYNTHIA ADAMS
K142205 02/20/2015 NuVasive X-CORE(R) Expandable VBR System NUVASIVE, INC. OLGA LEWIS
K150828 12/18/2015 O-RING Condom O-RING Products LLC William Mistler
K152945 12/15/2015 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K152809 12/31/2015 Giraffe Incubator Carestation CS1 OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. KENNY BELLO
K142785 12/17/2015 PRODIGY iConnect Blood Glucose Monitoring System OK BIOTECH CO., LTD. Jen Ke-Min
K142680 02/08/2015 ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT OLYMPUS MEDICAL SYSTEMS CORP. Daphney Germain-Kolawole
K143303 02/27/2015 Single Use Biliary Balloon Dilator OLYMPUS MEDICAL SYSTEMS CORP. Sheri Musgnung
K153437 12/21/2015 Apex Revision Knee System OMNILIFE SCIENCE CHRISTINA ROVALDI
K141157 12/22/2015 BONDEASE TOPICAL SKIN ADHESIVE OPTMED, INC. STEPHANIE RAIS
K140913 02/17/2015 NUROS BONE GRAFT SUBSTITUTE ORIENTAL RESOURCES DEVELOPMENT LIMITED MICHAEL LEE
K153306 12/18/2015 Imbibe Needle ORTHOVITA, INC. LYNN LUNDY
K142358 02/19/2015 Osstell IDx OSSTELL AB KARIN BREDING
K152145 12/21/2015 OsteoMed ExtremiLOCK Wrist Plating System OSTEOMED Piedad Pena
K141911 02/10/2015 OPTIMUS NEURO SYSTEM OSTEONIC CO., LTD. Priscilla Chung
K152267 12/15/2015 Remedy« Shoulder Spacer Osteoremedies LLC Chris Hughes
K143395 02/23/2015 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit OTODYNAMICS, LTD. Julian Rutherford
K153378 12/21/2015 Monster BITE Screw System PARAGON 28 Frank S. Bono
K152951 12/28/2015 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray PARAGON MEDICAL, INC. MIKE GOSMEYER
K142848 02/24/2015 EAZY PRIMER Parkell, Inc. David Mott
K152636 12/17/2015 Laser Dock PATIENT POCKET, LLC ALLEN D SEFTEL
DEN140020 02/12/2015 ECLIPSE SYSTEM PELVALON CINDY DOMECUS
K152840 12/02/2015 Lantern Delivery Microcatheter PENUMBRA, INC. CHARLES DENAULT
K150854 12/14/2015 ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut PHADIA AB Carina Magnusson
K141375 02/13/2015 ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 PHADIA US INC. MANUELA CONSTANZE HOG
K153480 12/16/2015 ClearVue850 Diagnostic Ultrasound System PHILIPS HEALTHCARE Saraswathi Deora
K153318 12/22/2015 Philips Eleva Workspot with SkyFlow Philips Medical Systems DMC GmbH MING XIAO
K151658 12/01/2015 Gmate Origin Blood Glucose Monitoring System Philosys Inc. LINDA CHAN
K143044 02/06/2015 CAAS A-Valve PIE MEDICAL IMAGING B.V. Florie Daniels
K142879 12/23/2015 BTM Wound Dressing POLYNOVO BIOMATERIALS PTY LTD Philip Powell
K151050 12/22/2015 Pacifier Activated Lullaby (PAL«) Power Medical Devices, LLC Patricia Palmer
K151413 12/18/2015 Always/Tampax bladder supports PROCTER & GAMBLE LENORE FAULHABER
K143514 12/11/2015 Panther StereoSeed PROWESS, INC. Rachel Scarano
K150806 12/16/2015 PulseFlowDF PulseFlow Technologies Les Lindsay
K152321 12/04/2015 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi QFIX NADIA SOOKDEO HARHEN
K152012 12/08/2015 EVO platform Quanta System SpA Francesco Dell'Antonio
K152714 12/21/2015 Quanta Forte QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K143126 02/06/2015 Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies Josh Brown
K141434 02/18/2015 SATURN 5 LASER RESEARCH INSTRUMENTS LTD. DAVID LANDSDOWNE
K152292 12/07/2015 Respire Blue Series-EF Respire Medical Holding David Walton
K140980 02/10/2015 TI NASAL MASK RESPIRONICS, INC. SHAYLEE MASILUNAS
K152624 12/07/2015 XSTAT 30, 3-PACK, XSTAT 30, 1-PACK REVMEDX, INC. AMY K. POINTER
K152542 12/24/2015 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs RIVERSTONE RESOURCES SDN BHD SURESH KUMAR
K141421 02/09/2015 PMMA BLOCK RIZHAO HUGE DENTAL INDUSTRY CO., LTD HELEN NAN
K150092 02/10/2015 STERISPINE PS Pedicle Screw SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K143029 02/04/2015 Digital Diagnostic X-ray System (GC80) SAMSUNG ELECTRONICS CO., LTD. KIM CHULSIN
K150097 02/19/2015 GM60A-32S & GM60A-40S SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K153401 12/21/2015 GR40CW SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K153408 12/21/2015 HM70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD Jiyoung Kim
K152513 12/15/2015 8X-10-XXXX Camera System Santa Barbara Imaging Systems James Candy
K133268 02/12/2015 TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS SCHUTZ-DENTAL GMBH MICHAEL WIERZ
K153189 12/17/2015 Beacon Tissue Marker (SE) SCION MEDICAL TECHNOLOGIES, LLC LOUIS LI
K142156 02/13/2015 SEEGENE ANYPLEX II HSV-1/2 ASSAY SEEGENE FRAN WHITE
K143382 02/23/2015 DentiAnn Smart Sil SeilGlobal Co., Ltd. Pack Seong Uk
K151639 12/07/2015 ABL80 FLEX and ABL80 FLEX CO-OX SENDX MEDICAL INC VIBEKE AGERLIN
K151329 12/17/2015 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet SENTEC AG ANKE WEISBRICH
K142924 02/13/2015 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family SHASER, INC. ANTHONY BURNS
K150664 12/22/2015 NeoLas SHEAUMANN LASER, INC Katina Sousa
K141946 02/13/2015 DIGITAL ELECTROCARDIOGRAPH SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. Diana Hong
K152384 12/18/2015 Digital Electrocardiograph SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. Hongbo Zhong
K151810 12/17/2015 Bpump Blood Pressure Cuff SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K151699 12/10/2015 BEAUTIFIL II Enamel SHOFU DENTAL CORPORATION Mauro Malyzyner
K152451 12/11/2015 VINTAGE Art LF SHOFU DENTAL CORPORATION MAURO MALZYNER
K142685 02/11/2015 NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE SIAM SEMPERMED CORP., LTD ANAN PRUKSANUSAK
K142826 12/22/2015 ADVIA Centaur Toxoplasma M (Toxo M) SIEMENS HEALTHCARE DIAGNOSTICS, INC. Matthew Gee
K153365 12/18/2015 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K143636 02/25/2015 IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Donna Velasquez
K143373 02/26/2015 IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. DONNA VELASQUEZ
K151767 12/11/2015 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. Laura J. Duggan
K150050 02/09/2015 ACUSON P500 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
K152283 12/24/2015 MAGNETOM Amira SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L FIELDS
K143319 02/24/2015 Syngo X-workplace SW VD10 Siemens Medical Solutions, Inc Patricia D. Jones
K143072 02/09/2015 ENROUTE Transcarotid Neuroprotection System SILK ROAD MEDICAL, INC Richard M Ruedy
K142436 02/19/2015 3S Safety Insulin Syringe Sincere Medical Device Co., Ltd. Garfield Wang
K142435 02/20/2015 3S Safety Syringe with/without Needle Sincere Medical Device Co., Ltd. Garfield Wang
K153208 12/31/2015 Internal Joint Stabilizer - Elbow SKELETAL DYNAMICS, LLC Ana M Escagedo
K150908 12/16/2015 XM-01 Electronic Automatic Blood Pressure Monitor Sky Innovation Technology ( Shanghai) Limited Charles Shen
K143172 02/04/2015 ACL SMART System SMITH & NEPHEW, INC. SAMIR IBRAHIM
K152566 12/02/2015 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor SMITH & NEPHEW, INC. KATHERINE MARCACCIO
K143226 02/12/2015 Visionaire Disposable Instruments SMITH & NEPHEW, INC. Shereen Bienz
DEN140024 12/23/2015 cNEP Airway Sommetrics Richard Rose
K152341 12/14/2015 ViSi Mobile Monitoring System SOTERA WIRELESS, INC Carson Krupp
K150201 02/27/2015 Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter SPECTRANETICS, INC. Christine Godleski
K142996 02/19/2015 StaXx(R) XD System SPINE WAVE, INC. Roaida Johnson
K143214 02/23/2015 SCARLET« AC-T Secured Anterior Cervical Cage SPINEART Franck PENNESI
K143377 02/12/2015 PedFuse Pedicle Screw System SPINEFRONTIER, INC. Manthan J Damani
K152355 12/10/2015 Twin Peaks Lumbar Interbody Fusion System SPINEWAY Julien Thao my
K152958 12/04/2015 INEX Absorbable Nasal Implant SPIROX, INC. MIKE ROSENTHAL
K151114 12/11/2015 Medismart ( Latex Surgeon?s Gloves powdered ) and Medismart + (Latex Surgeon?s Gloves Powder Free, Polymer coated with protein ST.MARYS RUBBERS PVT. LTD. Srinivasan. S
K152115 12/17/2015 Renew NCP-5 External Counterpulsation System Stage 2 Innovations Richard Kotz
K140900 02/12/2015 PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT STANMORE INC. SAMANTHA SHELLEY
K143260 02/23/2015 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider STERILMED, INC. NICOLE BOSER
K152651 12/15/2015 AccuLIF TL and PL Cage STRYKER CORPORATION AAKASH JAIN
K152632 12/02/2015 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory STRYKER CORPORATION SORAYA KING
K150127 02/04/2015 Laparoscopic Handles with peek Insulation Stryker Endoscopy Rebecca Goldberg
K143085 02/09/2015 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach STRYKER ORTHOPAEDICS Denise Daugert
K152532 12/18/2015 AERO -C Cervical Cage System STRYKER SPINE SORAYA KING
K153154 12/28/2015 Asnis JFX System Stryker Trauma AG Garry T. Hayeck
K152692 12/21/2015 Powder Free Vinyl Patient Examination Gloves (Green) Supermax Plastic Products Co., Ltd Wu Zhigang
K150524 12/16/2015 Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology Surgical Instrument Services and Savings, Inc Richard D Wynkoop
K142242 02/02/2015 PREMIUM, SHELTA Implant Systems SWEDEN & MARTINA S.P.A. GLORIANNA ZANGIACOMI
K143209 02/05/2015 SonicFill 2 SYBRON DENTAL SPECIALTIES KERRI CASINO
K151936 12/04/2015 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle SYNAPTIC MEDICAL LIMITED Yang Tiecheng
K143123 02/24/2015 Synergetics PHOTON EX Synergetics Dan Regan
K152239 12/02/2015 Zero-P Natural Plate System Synthes (USA), LLC Beth Becotte
K143469 02/12/2015 SOFTECH Plus ETCO2 Cannula TELEFLEX MEDICAL, INC. Brian Gall
K150148 02/20/2015 Terason uSmart3300 Ultrasound System TERATECH CORP. Steven R Broadstone
K153140 12/02/2015 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP. JOSHUA P. EWING
K153376 12/16/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation Bryan Hann
K153143 12/02/2015 Capiox Advance Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A. Brown
K153213 12/03/2015 Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A Brown
K152173 12/01/2015 Glidesheath TERUMO MEDICAL CORPORATION ERIN DOYLE
K141657 02/24/2015 THD REVOLUTION THD SPA MAURIZIO PANTALEONI
K152389 12/18/2015 Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit THE BINDING SITE GROUP LTD STEPHANIE THOULESS
K143314 02/27/2015 Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Company, LLC SCOTT KEISER
K150676 12/23/2015 L-Mesitran Dressing Family II- Soft and Tulle Theo Manufacturing BV Monique Gottgens
K143381 02/19/2015 Sensititre Susceptibility Plates Thermo Fisher Scientific Cynthia Knapp
K152774 12/21/2015 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K142894 02/03/2015 TCS Blend Thermoplastic Comfort Systems, Inc. Marilin Posca
K141504 02/24/2015 T-8000 THEROZONE UNIT THEROZONE USA, INC. Rebecca K Pine
K142767 02/03/2015 ThinkMed Intermittent Catheter with/without Hydrophilic Coating ThinkMed Medical Technology Co., Ltd. Garfield Wang
K153122 12/14/2015 Endoskeleton(r) TCS System TITAN SPINE, LLC Jane Rodd
K152202 12/14/2015 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm TNI Manufacturing, Inc. Daniel Sablyak
K152128 12/23/2015 2-in-1 Abdominal Muscle Training & Back Pain Relief System Tohkai Precision Electrical Manufactory (Shenzhen) Limited Yuk Wing Li
K150122 02/13/2015 TOMTEC-ARENA TTA2 TOMTEC IMAGING SYSTEMS, GMBH CHRISTINE KLEIN
K153417 12/18/2015 ST AIA-PACK PROG III Calibrator Set TOSOH BIOSCIENCE, INC. ROBERT L. WICK
K153310 12/17/2015 Klassic Knee System TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K150105 02/17/2015 Klassic Knee System-Sombrero Patella TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K151916 12/18/2015 TRI Dental Implant System TRI DENTAL IMPLANTS INT. AG SANDRO VENANZONI
K141183 02/27/2015 EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES TTBIO CORP. SHU-CHING LEE
K143417 02/25/2015 ANAX 5.5 Spinal System U&I Corporation Young-Geun Kim
K140949 02/09/2015 ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE ULTIMED INCORPORATED MARY BETH HENDERSON
K150147 02/19/2015 Lubrigyn cream UNIDERM FARMACEUTICI SRL Giorgio Chiozza
K142832 02/06/2015 Unimed Disposable and Reusable SPO2 Sensors UNIMED MEDICAL SUPPLIES INC. Xinmei Tan
K153362 12/16/2015 AquaShield system CO2, AquaShield system-PENTAX UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
K142248 02/20/2015 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope Urologix, Inc. Georgiann Keyport
K150716 12/08/2015 Varaya Sport VARAYA PHOTOCEUTICALS, LLC Myk Lum
K151022 12/17/2015 Intraluminal Applicator Set VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K152387 12/18/2015 Fluent Inflation Device VASCULAR SOLUTIONS, INC. BEKA VITE
K143652 02/26/2015 Vector PTA Balloon Dilatation Catheter Vector Corporation LLC Jay Sturm
K150869 12/10/2015 Checkme Pro Health Monitor Viatom Technology Co., Ltd. Zhou Saixin
K142775 02/13/2015 Neuwater TM (HydrocynTM aqua) Vigilenz Medical Devices Shudipta Choudhury
K150992 12/16/2015 Vios Monitoring System VIOS MEDICAL, INC. MEGAN GRAHAM
K152373 12/30/2015 VITA VM LC Flow VITA ZAHNFABRIK H. RAUTER GMBH & CO. Bernd Walker
K152139 12/06/2015 Vital Connect Platform, HealthPatch MD, VitalPatch VITAL CONNECT, INC. BONNIE WU
K150961 12/04/2015 EmbryoSlide Culture Dish VITROLIFE A/S BELINDA DUEHOLM
K150950 12/21/2015 FreezeKit Cleave , ThawKit Cleave VITROLIFE SWEDEN AB Brett Sonet Glazar
K152582 12/03/2015 CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box VOLCANO CORPORATION NATHAN DA SILVA
K153369 12/22/2015 SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz VOLCANO CORPORATION Brian Park
K153094 12/31/2015 Visions PV .035 Digital IVUS Catheter Volcano Corporation Neeta Sharma
K143122 02/20/2015 Volcano iFR Harvest Software (Offline) Volcano Corporation Neeta Sharma
K150162 02/26/2015 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. John Wan
K152609 12/11/2015 GORE SYNECOR Biomaterial W.L GORE & ASSOCIATES, INC. BARBARA L. SMITH
K150336 02/24/2015 Photonica Professional Ward Photonics LLC Terry Ward
K151900 12/11/2015 VariLift-L Interbody Fusion Device WENZEL SPINE, INC. BECKINAM NOWATZKE
K152851 12/24/2015 BrainPort V100 WICAB, INC. ROBERT BECKMAN
K152118 12/16/2015 Zenostar MT, Zenostar Color Liquids WIELAND DENTAL + TECHNIK GMBH & CO. KG BETINA KISTNER
K152782 12/21/2015 SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT WILLIAM A. COOK AUSTRALIA PTY LTD GORDANA POZVEK
K152904 12/03/2015 SYDNEY IVF EMBRYO BIOPSY MEDIUM WILLIAM A. COOK AUSTRALIA PTY, LTD. GORDANA POZVEK
K151714 12/03/2015 Disposable Endoscope Valves Set A WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED LIJUAN ZHANG
K152038 12/22/2015 MammoGRIP Women's Imaging Solutions Enterprises LLC Nancy DeRobertis
K150073 02/10/2015 MICRONAIL Distal Radius System Wright Medical Technology, Inc. Jeanine Redden
K152974 12/11/2015 ORTHOLOC« 3Di Foot Plating Reconstruction System Wright Medical Technology, Inc. Val Myles
K150640 12/01/2015 RX-FIX Mini Rail External Fixator WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K141982 02/05/2015 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WRP ASIA PACIFIC SDN. BHD. SARALA DEVI JAYARAMAN
K151890 12/23/2015 Medical Diode Laser Systems Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing
K142479 02/24/2015 MEGNA BREAST PUMPS WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. ANNE CHEN
K151284 12/21/2015 Electric Double Breast Pumps Wuxi Xinzhongrui Baby Supplies Co.,Ltd Shaozhong Chen
K152987 12/11/2015 Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System XENCO MEDICAL, LLC GUSTAVO PRADO
K143055 02/12/2015 Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla YTY INDUSTRY (MANJUNG) SDN. BHD. Arivalagan Subramaniam
K143200 02/03/2015 MIS Z-Pedicle Screw System Z-Medical GmbH & Co. KG ALEXANDER HENNINGER
K151498 12/18/2015 Breathing circuit bacterial/viral filter ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. HU JUBIN
K143297 02/12/2015 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) Zimmer Spine, Inc. Donna M. Semlak
K151907 12/30/2015 Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables ZIMMER, INC. PATRICK MCCULLAGH
K152484 12/04/2015 FastFrame External Fixation System - Distal Radius ZIMMER, INC. DOROTHY SNYDER
K152755 12/21/2015 FastFrame External Fixation System-Ankle Spanning Zimmer, Inc. Dorothy Snyder
K143618 02/06/2015 Kirschner Wires, Steinmann Pins ZIMMER, INC. PATRICK MCCULLAGH
K150028 02/06/2015 Zimmer Segmental System XT Components ZIMMER, INC. KEITH J. PROCTOR
K150121 02/23/2015 Zimmer Periarticular Plating System ZIMMER,INC. PATRICK MCCULLAGH
K142693 02/20/2015 ZywieAI Software Library Zywie, Inc. Latha Ganeshan


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