FDA 510(k) Decisions During February, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K143058 02/13/2015 PuraDerm Gel 3-D Matrix, Inc. Lisa Spirio
K143276 02/05/2015 Acumed Small Bone IM Nail System Acumed, LLC Nathan Wolf
K150233 02/26/2015 NIOX VERO Airway Inflammation Monitor AEROCRINE AB Kathleen Rickard
K150062 02/09/2015 Excia Total Hip System AESCULAP IMPLANT SYSTEMS, LLC JULIE TOM WING
K143337 02/17/2015 CONELOG Titanium base CAD/CAM ALTATEC GMBH DENNIS PAPPAS
K143632 02/13/2015 Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens Bausch & Lomb Incorporated Jessica Burger
K142985 02/26/2015 UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator BECKMAN COULTER, INC. Eimear Carr
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
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
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
K143705 02/20/2015 NeedleCam HD Visualization System BIOVISION TECHNOLOGIES, LLC DAVID SANSO
K142858 02/09/2015 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) Careplus (M) SDN BHD Lim Kwee Shyan
K143302 02/12/2015 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 CEPHEID KERRY J FLOM
K142716 02/10/2015 VCARE CONMED CORPORATION ANNA D'LIMA
K143415 02/26/2015 Air Bubble Based Infuser (ABBI) CooperSurgical, Inc James Keller
K143088 02/25/2015 GastriSail Gastric Positioning System COVIDIEN Debbie Peacock
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
K142880 02/04/2015 DMRC Light Cure Orthodontic Adhesive System Daville Materials LLC Dong Hua
K142987 02/11/2015 DD Bio Z, DD Bio ZX(square), DD BioZX(square) color DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) Gerhard de Boer
K143362 02/03/2015 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products John Siegel
K143127 02/13/2015 CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style DISPO-MED (MALAYSIA) SDN BHD NC LEOW
K150190 02/26/2015 IntraTemp Solution Warmer Ecolab Inc. Michelle Nivala
K142576 02/26/2015 Spinal System EISERTECH, LLC Lukas Eisermann
K150020 02/25/2015 Irritrol, EDS Combo-Rinse ESSENTIAL DENTAL SYSTESM, INC. JEFFREY WAN
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
K143228 02/26/2015 Ancora LLC Interbody Fusion Device FRONTIER MEDICAL DEVICES, INC. ERIC SEABORG
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
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
K143183 02/17/2015 Maxima XTEND Handpiece Maintenance System HANDPIECE HEADQUARTERS Timothy Ropchan
K142731 02/27/2015 HEARTWAY Electrically Powered Wheelchairs HEARTWAY Medical Products Co., Ltd. Dr. Ke-Min Jen
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
K143500 02/06/2015 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set 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
K150174 02/26/2015 EMMA INRANGE SYSTEMS, INC. Christopher E Bossi
K142956 02/24/2015 NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit Integrated Healing Technologies Ian Baird
K142937 02/24/2015 Endoscope Sterilization Tray INTUITIVE SURGICAL, INC. Nadine Nasr
K150009 02/25/2015 Baide Jiangsu Baide Medical Intrument Co.,Ltd. Mr.Kang Shui
K143350 02/25/2015 Nile Alternative Fixation K2M, Inc. Nancy Giezen
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
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
K143635 02/20/2015 KINETIS Total Knee System MAKO SURGICAL JONATHAN REEVES
K143191 02/20/2015 IntelliSense Drill McGinley Innovations Joseph McGinley
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
K143111 02/19/2015 Codman Certas Plus Programmable Valve; Codman Certas Toll Kit MEDOS INTERNATIONAL SARL Michelle Godin
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
K150200 02/25/2015 CD HORIZON Growth Rod Conversion Set MEDTRONIC SOFAMOR DANEK USA, INCORPORATED LEE GRANT
K150246 02/18/2015 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc Becky Severson
K142597 02/19/2015 Vienna System MICK RADIO-NUCLEAR INSTRUMENTS, INC. Chuck Smith
K143457 02/19/2015 NeuroBlate System MONTERIS MEDICAL, INC. Brooke Ren
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
K143135 02/20/2015 Spring Coil Guidewire NeoMetrics, Inc. Gene Champeau
K143230 02/25/2015 Palladian Lumbar Pedicle Screw System Neurostructures, Inc. Moti Altarac
K142774 02/18/2015 Polysmith Sleep System Neurotronics, Inc. David Pezet
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
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
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
K142848 02/24/2015 EAZY PRIMER Parkell, Inc. David Mott
K143044 02/06/2015 CAAS A-Valve PIE MEDICAL IMAGING B.V. Florie Daniels
K143126 02/06/2015 Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies Josh Brown
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
K143382 02/23/2015 DentiAnn Smart Sil SeilGlobal Co., Ltd. Pack Seong Uk
K142924 02/13/2015 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family SHASER, INC. ANTHONY BURNS
K142685 02/11/2015 NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE SIAM SEMPERMED CORP., LTD ANAN PRUKSANUSAK
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
K150050 02/09/2015 ACUSON P500 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
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
K143172 02/04/2015 ACL SMART System SMITH & NEPHEW, INC. SAMIR IBRAHIM
K143226 02/12/2015 Visionaire Disposable Instruments SMITH & NEPHEW, INC. Shereen Bienz
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
K143260 02/23/2015 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider STERILMED, INC. NICOLE BOSER
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
K143209 02/05/2015 SonicFill 2 SYBRON DENTAL SPECIALTIES KERRI CASINO
K143123 02/24/2015 Synergetics PHOTON EX Synergetics Dan Regan
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
K143314 02/27/2015 Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Company, LLC SCOTT KEISER
K143381 02/19/2015 Sensititre Susceptibility Plates Thermo Fisher Scientific Cynthia Knapp
K142894 02/03/2015 TCS Blend Thermoplastic Comfort Systems, Inc. Marilin Posca
K142767 02/03/2015 ThinkMed Intermittent Catheter with/without Hydrophilic Coating ThinkMed Medical Technology Co., Ltd. Garfield Wang
K150122 02/13/2015 TOMTEC-ARENA TTA2 TOMTEC IMAGING SYSTEMS, GMBH CHRISTINE KLEIN
K150105 02/17/2015 Klassic Knee System-Sombrero Patella TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K143417 02/25/2015 ANAX 5.5 Spinal System U&I Corporation Young-Geun Kim
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
K143652 02/26/2015 Vector PTA Balloon Dilatation Catheter Vector Corporation LLC Jay Sturm
K142775 02/13/2015 Neuwater TM (HydrocynTM aqua) Vigilenz Medical Devices Shudipta Choudhury
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
K150336 02/24/2015 Photonica Professional Ward Photonics LLC Terry Ward
K150073 02/10/2015 MICRONAIL Distal Radius System Wright Medical Technology, Inc. Jeanine Redden
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
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
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


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