FDA 510(k) Decisions During January, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K143573 01/16/2015 Audit MicroControls Linearity FD Tumor Markers II AALTO SCIENTIFIC LTD. Robert Burda
K143571 01/23/2015 Audit MicroControls Linearity LQ Cystatin-C AALTO SCIENTIFIC, LTD. ROBERT BURDA
K142816 01/14/2015 AbbVie J ABBVIE INC. Katherine Wortley
K142792 01/14/2015 AbbVie NJ ABBVIE INC. Katherine Wortley
K142793 01/14/2015 AbbVie PEG AbbVie Inc. Katherine Wortley
K143394 01/23/2015 Acumed Small Fragment Base Set ACUMED LLC Nathan Wolf
K142743 01/27/2015 AliveCor Heart Monitor AliveCor, Inc. Albert Boniske
K143149 01/05/2015 Arsenal Spinal Fixation System ALPHATEC SPINE, INC. RENEE MURPHY
K142889 01/27/2015 Celerity PICC Tip Confirmation System ANGIODYNAMICS, INC. Michael Hanley
K143757 01/08/2015 ANUTRA Feedback Aspiration Syringe ANUTRA MEDICAL, INC. CAMERON PERKINS
K142989 01/29/2015 Mini ONE Enteral Extension Set APPLIED MEDICAL TECHNOLOGY, INC. Joshua Meinke
K142914 01/12/2015 DacryoCATH ARMADILLO BIOMEDICAL, LLC Bruce Becker, M.D.
K142641 01/12/2015 Intelliwave4 ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K143139 01/16/2015 Arthrex Fracture System ARTHREX, INC. David Rogers
K143614 01/16/2015 Arthrex Low Profile Screws ARTHREX, INC. David L Rogers
K143178 01/30/2015 FilmArray 2.0 System BioFire Diagnostics, LLC Kristen Kanack, PhD
K143171 01/30/2015 FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC. Kristen Kanack, PhD
K142828 01/15/2015 osteoSPAN Morpheus BIOGENNIX Edwin Clayton Shors
K143022 01/08/2015 BioHorizons Tapered Internal Implants BIOHORIZONS IMPLANT SYSTEMS, INC. Michael Davis
K143023 01/16/2015 Nitinol Compression Plating System BioMedical Enterprises, Inc. Joe Soward
K143543 01/30/2015 Prelude PF Patellae BIOMET INC. JARED COOPER
K143037 01/20/2015 SnapShot Fixation System BIOMET MANUFACTURING CORP. Adam Cargill
K143298 01/16/2015 Ultrasound Scanner System bk2300 BK MEDICAL APS RANDI HAUERBERG
K143006 01/16/2015 GUARDIAN-SG Inflatable Bone Expander System BM KOREA CO., LTD. June Han
K143587 01/15/2015 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire BOSTON SCIENTIFIC CORPORATION NIKKI M WAHLBERG
K142922 01/16/2015 SpyGlass DS Direct Visualization System BOSTON SCIENTIFIC CORPORATION CARTER NAVARRO
K143151 01/26/2015 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) BSN MEDICAL GMBH MARTIN SPENGLER
K143040 01/15/2015 Exilis XP BTL INDUSTRIES INC Jan Zarsky
K143522 01/12/2015 Presto Inflation Device C.R. BARD, INC. TIMOTHY WADE
K143490 01/26/2015 VERTA Corpectomy Cage CAMBER SPINE Daniel A. Pontecorvo
K143718 01/22/2015 Mammography Color Display DP-M3010 CANON INC. MASAKI TAMURA
K143199 01/29/2015 Capillus 272 Pro Capillus, LLC Frances Pina Brea
K142862 01/16/2015 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). Careplus (M) SDN BHD Lim Kwee Shyan
K143392 01/23/2015 Quattro Bolt Tenodesis Screw CAYENNE MEDICAL, INC Shima Hashemian
K143247 01/22/2015 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) CENTRAL MEDICARE SDN BHD TH Chong
K142655 01/26/2015 CB PROT II Posterior Spinal System CHIN BONE TECHNIQUE CORP CHENG-KUNG CHENG
K143396 01/23/2015 omni TRAX Active Patient Tracker CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions Amanda Stahle
K143182 01/20/2015 Speedicath Compact Male COLOPLAST A/S Brian Schmidt
K142825 01/20/2015 Zmachine CONSOLIDATED RESEARCH OF RICHMOND, INC Richard Kaplan
K143412 01/14/2015 ADROIT Guiding Catheter CORDIS CORPORATION BABU PERIASAMY
K142929 01/27/2015 Ligasure Blunt Tip Sealer/Divider COVIDIEN CELSO DURAN
K142656 01/29/2015 Surgical Gut Suture COVIDIEN Mary Mellows
K143625 01/15/2015 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K143317 01/20/2015 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Currie Medical Specialties, Inc. Owen J. Bry
K142932 01/22/2015 Deltex Medical KDP72 Doppler Probe DELTEX MEDICAL LIMITED Paul Dwane
DEN140038 01/23/2015 Dexcom Share Direct Secondary Displays DEXCOM, INC. Andrew K Balo
K142749 01/18/2015 TruWave Disposable Pressure Transducer EDWARDS LIFESCIENCES, LLC. ANDREW S. MAZURKIEWICZ
K142599 01/16/2015 PRECISE Trauma Nail System Ellipse Technologies, Incorporated Rebecca Shelburne
K142773 01/22/2015 EOS System EOS IMAGING Karine Chevrie
K143007 01/15/2015 Erchonia Zerona Z6 OTC ERCHONIA CORPORATION Steve Shanks
K143129 01/29/2015 easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) EziSurg Medical Co.,Ltd. Johnny Yan
K143124 01/26/2015 KA01 Chitosan Wound Dressing FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. JOHN CEN
K143452 01/29/2015 LOGIQ P9, LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K142840 01/07/2015 Unity Network ID GE HEALTHCARE Robert Casarsa
K143633 01/30/2015 CREO Stabilization System GLOBUS MEDICAL INC. Kelly J. Baker
K143535 01/13/2015 CR3 Keyless Split Sample Cup Secobarbital- Methadone GUANGZHOU WONDFO BIOTECH CO., LTD. Ben Chen
K142759 01/13/2015 PK Cutting Forceps for ESG-400 Workstation GYRUS ACMI, INC. DOLAN MILLS
K143187 01/27/2015 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Healgen Scientific LLC Jianqiu Fang
K142703 01/15/2015 Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co., Ltd. Wei Liu
K142837 01/29/2015 HEINE SIGMA 250 & HEINE SIGMA 250 M2 HEINE Optotechnik GmbH & Co. KG Bettina Seim
K143594 01/09/2015 VaPro Pocket Hollister Incorporated Jeanne Lee
K142974 01/09/2015 Extension Sets Hospira, Inc David Blonski
K142622 01/15/2015 IV Administration HOSPIRA, INC. DAVID BLONSKI
K142952 01/13/2015 InMode Diolaze Device INMODE MD LTD. Ahava Stein
K142939 01/13/2015 Revolution Spinal Fixation System INTELLIGENT IMPLANT SYSTEMS, LLC Michael Nutt
K143154 01/02/2015 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) IRIDEX CORPORATION PAUL H HARDIMAN
K142957 01/30/2015 Ideal pedicle screw spinal system JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. Wei Li
K143155 01/29/2015 LISTERINE Sensitivity Defense Mouthrinse Johnson & Johnson Healthcare Products, Division of McNeil-PP ANGELINA M. HUNT
K143334 01/09/2015 Range/Denali/Mesa Spinal System K2M, INC NANCY GIEZEN
K142625 01/27/2015 PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) KURARAY NORITAKE DENTAL INC. Michio Takigawa
K143498 01/20/2015 LifeGlobal Global HP LifeGlobal Group, LLC MICHAEL D CECCHI
K143509 01/27/2015 MasterSL femoral stem LIMACORPORATE S.P.A. STEPHEN J PEOPLES
K142722 01/13/2015 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 Livetec GMBH Klaus Reichenbach
K142860 01/21/2015 Lumenis M22 System Lumenis Ltd. Yoram Levy
K142606 01/26/2015 Trident« Tritanium« PST« Acetabular Shells MAKO Surgical Corp. Jonathan Reeves
K142850 01/06/2015 McKesson Radiology Mammography Plus MCKESSON MEDICAL IMAGING COMPANY GILBERT WONG
K143068 01/14/2015 Medical Monofilament Sensory Screening Toool Medical Monofilament Manufacturing Michelle Hardiman
K143634 01/20/2015 MUSE System MEDIGUS LTD. SHARON KANETY DERESH
K142635 01/09/2015 Medline Silicone Foley Catheter MEDLINE INDUSTRIES, INC. Matt Clausen
K143107 01/07/2015 DLP Vein Graft Cannula MEDTRONIC, INC. KEVIN LAM
K143232 01/30/2015 Universal Digital Interface 2W, UDI 2W MERIDIAN MEDICAL SYSTEMS, LLC Larry Cornell
K143366 01/21/2015 ADVANCE Porous Coated Spiked Tibial Base MicroPort Orthopedics Inc. Caroline Fryar
K143426 01/27/2015 Wound Matrix TF MIROMATRIX MEDICAL INC. Jeff Ross
K142866 01/21/2015 Myoscience iovera system Myoscience, Inc Tracey Henry
K143061 01/26/2015 Activ Ankle Locking Plating System NEWCLIP TECHNICS Gaelle Lussori
K142590 01/16/2015 All Safe Huber Safety Infusion Set NEXUS MEDICAL, LLC Heather Turner
K142712 01/08/2015 Dental Collagen Wound Dressing (Nova Tape and NovaPlug) NovaBone Products, LLC Lisa Simpson
K143065 01/21/2015 NuVasive ALIF Buttress Plate System NUVASIVE, INCORPORATED Michelle Cheung
K142583 01/16/2015 LaborView LV1000 OBMedical Company Suha Jhaveri
K142897 01/16/2015 P200DTx OPTOS PLC. GUNHILD PAULSEN
K143039 01/16/2015 CrossRoads Screw System ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM VERNON HARTDEGEN
K142678 01/21/2015 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm OTICON MEDICAL AB Carolina Anker Wessling
K142935 01/15/2015 CareEvent PHILIPS MEDICAL SYSTEMS Theresa Poole
K143000 01/23/2015 RIS500 RAY CO.,LTD KYUNGHA SEO
K142554 01/09/2015 Revolution Full Face Mask Respironics, Inc. Amy Macevoy
K143481 01/08/2015 IntellaMap Orion High Resolution Mapping Catheter RHYTHMIA MEDICAL, INC FRANK JURCZAK
K143691 01/28/2015 LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (RDO) Noel B Mencias
K143483 01/08/2015 MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING SEBIA Karen Anderson
K142675 01/15/2015 CI../..X liner for NOVAE Dual Mobility Acetabular Cup SERF Jean-Luc AURELLE
K142552 01/23/2015 A7 Anesthesia System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Tang Hao
K143472 01/02/2015 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K143639 01/23/2015 IMMULITE 2000 CEA Calibration Verification Material Siemens Healthcare Diagnostics Asha Gartland
K143504 01/14/2015 IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material Siemens Healthcare Diagnostics Inc. Sara Kastrup
K143680 01/27/2015 ADVIA Centaur IgE Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Fatima Pacheco
K142584 01/16/2015 iMAR Siemens Medical Solutions USA, Inc. Eve Davis
K143493 01/14/2015 SignosRT Bladder Ultrasound System Signostics Ltd Stewart Bartlett
K143624 01/13/2015 Headless Compression Screw System SKELETAL DYNAMICS, LLC Ana M. Escagedo
K142948 01/13/2015 BIOSURE REGENESORB interference Screw Smith & Nephew, Inc Vivek Mukhatyar
K142945 01/22/2015 Sonoma Fibula Repair System SONOMA ORTHOPEDIC PRODUCTS, INC. RICK EPSTEIN
K142815 01/28/2015 S22 Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED Toki Wu
K142714 01/29/2015 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED Toki Wu
K142710 01/05/2015 S9 Portable Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED TOKI WU
K143751 01/23/2015 Visi Mobile Monitoring System Sotera Wireless, Inc. Eben Gordon
K142791 01/21/2015 Spectra Soft Tissue Biopsy Needles SPECTRA MEDICAL DEVICES Agustin Turriza
K142980 01/16/2015 Proficient (TM) Facet Screw Spine System SPINE WAVE, INC. ROAIDA JOHNSON
K143159 01/23/2015 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv SpineGuard, S.A. Stephane Bette
K142667 01/07/2015 Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm Sterngold Dental, LLC Maria Rao
K142890 01/09/2015 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Singl STRAUMANN USA, LLC Jennifer M. Jackson
K143163 01/26/2015 AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System STRYKER CORPORATION GARRY T HAYECK
K142741 01/15/2015 OASYS System STRYKER CORPORATION Garry T Hayeck
K143393 01/13/2015 Triathlon Tritanium Cone Augments STRYKER ORTHOPAEDICS Margaret Klippel
K143063 01/27/2015 Stryker SonicPin System, Stryker SonicAnchor System STRYKER TRAUMA GMBH Estela Celi
K143588 01/12/2015 Surefire Infusion System 021 SUREFIRE MEDICAL, INC Lynne Aronson
K143166 01/16/2015 Medline ReNewal Reprocessed Compression Limb Sleeves Surgical Instrument Service and Savings (dba Medline ReNewal Richard D. Wynkoop
K143589 01/16/2015 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. Jodi Jorgenson
K142838 01/20/2015 Synapse Occipital-Cervical-Thoracic (OCT) System SYNTHES USA PRODUCTS, LLC KATE LAROSE
K143189 01/09/2015 t:flex Insulin Delivery System Tandem Diabetes Care, Inc. John Sheridan
K143299 01/21/2015 Percuvance(R) Percutaneous Surgical System Teleflex Medical, Inc. Holly Hallock
K142940 01/28/2015 Endoskeleton TCS System TITAN SPINE, LLC Jane Rodd
K143059 01/26/2015 TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) TONE-A-MATIC INTERNATIONAL INC. MANUEL CHUCK
K143223 01/12/2015 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143225 01/09/2015 INFX-8000V with Wireless Footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143281 01/29/2015 Ultimax-i TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143113 01/28/2015 Klassic BiPolar System Total Joint Orthopedics Chris Weaber
K143311 01/15/2015 Pre-vacuum Tabletop Autoclave TUTTNAUER USA CO. LTD. Robert Basile
K142553 01/14/2015 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle UNISIS CORP. Tadashi Yasuda
K142946 01/08/2015 TIVA Velano Vascular, Inc. Tiffini Diage
K143549 01/14/2015 Vivorte Trabexus VIVORTE, INC ROBERT BURDEN
K143547 01/14/2015 Vivorte Trabexus EB VIVORTE, INC Robert Burden
K143486 01/07/2015 Ufi Gel hard C VOCO GMBH M.Th. Plaumann
K143179 01/30/2015 The LINK« Endo-Model« Knee System Waldemar Link GmbH & Co. KG Helmut D. Link
K143460 01/23/2015 Cannulated Screw System WRIGHT MEDICAL TECHNOLOGY, INC. Tara Conrad
K143220 01/08/2015 SIDEKICK EZ FRAME External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K143190 01/16/2015 Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K142572 01/21/2015 Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Zimmer Dental, Inc. Christina Boydston


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