FDA 510(k) Decisions During December, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K142686 12/18/2014 StimPad OTC AEMED, INC. John K Burke
K142707 12/19/2014 AIS Odontoid Fracture Fixation System AESCULAP IMPLANT SYSTEM, INC. Lisa M Boyle
K142672 12/03/2014 AliveCor Heart Monitor ALIVECOR, INC. Albert Boniske
K142607 12/11/2014 AngioVac Circuit ANGIODYNAMICS Gary Barrett
K142944 12/16/2014 ArthroPlan Digital Templating Software Arthromeda, Inc Elsa Abruzzo
K142942 12/19/2014 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System ARTHROSURFACE INC. Dawn J. Wilson
K142619 12/18/2014 Snap Insulin Pump System ASANTE SOLUTIONS, INC EDWARD SINCLAIR
K143067 12/22/2014 Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC. JON P. HUNT
K143188 12/30/2014 3.Omm Biomet Cannulated Screw System BIOMET MANUFACTURING CORP. VICTORIA SCHEITLIN
K142746 12/29/2014 G7 Finned Acetabular Shell BIOMET MANUFACTUTING CORP. TRACY JOHNSON
K142933 12/23/2014 Biomet Tibial trays BIOMET, INC. JASON HECKAMAN
K143009 12/18/2014 Echo Bi-Metric Microplasty Hip System BIOMET, INC. Julie Gantenberg, M.S.,RAC
K142973 12/01/2014 Resolution Clip Boston Scientific Corporation Elena Nieves
K142975 12/12/2014 Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation Moshe Citronowicz
K143208 12/09/2014 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc Laurie Sang
K142580 12/01/2014 Chemtrue Multi-Panel DOA DIP Card Tests CHEMTRON BIOTECH, INC. Jane Zhang
K142800 12/11/2014 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard Co-Innovation Biotech Co., Ltd. Hong Feng
K142688 12/19/2014 Echotip Procore HD Ultrasound Biopsy Needle COOK IRELAND LTD Nora O'Connor
K142547 12/09/2014 Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm COVIDIEN MARY MELLOWS
K143161 12/19/2014 Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) COVIDIEN Sharon McDermott
K142643 12/15/2014 Stabilynx PEEK Suture Anchor D3 DC, LLC /Stabilynx, Inc Mike Rosenthal
K143378 12/29/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K143186 12/18/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K142571 12/17/2014 Powder Free Vinyl Patient Examination Gloves EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K142570 12/18/2014 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K142620 12/12/2014 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe Excelsior Medical Corporation John Linfante
K142609 12/18/2014 CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K142700 12/19/2014 InsufflatOR Needle GYNETECH PTY. LTD. Kevin MacDonald
K142805 12/18/2014 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) HARTALEGA SDB. BHD. KUAN KAM HON
K142588 12/18/2014 Nitrile Powder Free Examination Glove (Blue) HARTALEGA SDN BHD KUAN KAM HON
K142968 12/19/2014 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co.,Ltd. Sarah Su
K142997 12/17/2014 RTHawk, HeartVista Workstation with RTHawk HEARTVISTA, INC. James J Rogers
K142891 12/17/2014 HEPATIQ HEPATIQ LLC Dipu Ghosh
K142631 12/18/2014 Hermes Medical Imaging Suite v5.5 HERMES MEDICAL SOLUTIONS, AB Joakim Arwidson
K143339 12/19/2014 Mini me ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) BOBAE KIM
K142638 12/19/2014 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) InnovaQuartz LLC Stephen Griffin
K143217 12/03/2014 12 mm & Stapler Bladeless Obturators INTUITIVE SURGICAL, INC. Manish Patel
K142683 12/10/2014 12 mm Endoscopes and Accessories INTUITIVE SURGICAL, INC. Crystal Ong
K142564 12/23/2014 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation Sho Hosoki
K142558 12/22/2014 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M Nancy Giezen
K143164 12/02/2014 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set KIMBERLY-CLARK CORPORATION MARIA E WAGNER
K142803 12/02/2014 Skintact, various other tradenames Leonhard Lang GmbH Burrhus Lang
K142573 12/01/2014 HairMax LaserComb, HairMax LaserComb LEXINGTON INTERNATIONAL, LLC DAVID MICHAELS
K143145 12/04/2014 SafeAir Smoke Pencil LiNA Medical ApS Anne Klitgard
K142682 12/22/2014 The Lipogems System Lipogems International SpA Carlo Russo
K143119 12/18/2014 LT-300 Video Colposcope Lutech Industries, Inc. Ron Vachula
K142728 12/04/2014 ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) Medical Compressions System (DBN) Ltd. Eyal Sandach
K142702 12/18/2014 Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad MEDIVANCE, INC. Stacci Cronk
K143175 12/31/2014 AEx Generator; PlasmaBlade T MEDTRONIC ADVANCED ENERGY Deep Pal
K143141 12/01/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Gregory Maschek
K142591 12/01/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K142611 12/31/2014 TYRX Neuro Absorbable Antibacterial Envelope MEDTRONIC TYRX, INC. REGINA NOVAK
K142772 12/16/2014 Phlebo Press DVT 603 Mego Afek AC Ltd. Aharon Cohen
K142998 12/19/2014 CPX Control Breast Tissue Expander MENTOR WORLDWIDE LLC Manchi Cheung
K143429 12/22/2014 Passage Hemostasis Valve MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K142951 12/10/2014 MD210C3 21.3 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD. Satoru Kotani
K142697 12/23/2014 NExCT 7 NEUROLOGICA CORPORATION Ninad Gujar
K143197 12/23/2014 Nice1 NICE RECOVERY SYSTEMS, LLC MICHAEL ROSS
K142737 12/18/2014 MAS PLIF Fixation system NUVASIVE, INCORPORATED OLGA LEWIS
K142917 12/01/2014 BP652N (HEM-6300-Z) OMRON Healthcare, Inc Renee Thornborough
K142671 12/05/2014 ONEFIT HIP PLANNER ONEFIT MEDICAL JULIEN SIMON
K142639 12/16/2014 StitchKit ORIGAMI SURGICAL LLC Patrick Culligan
K143069 12/22/2014 HEMASORBPLUS press Resorable Hemostatic Bone Putty ORTHOCON, INC. Howard L Schrayer
K143125 12/10/2014 Orthofix True Lok Hexapod System VI.3 Orthofix Srl Gianluca Ricadona
K143244 12/15/2014 The Panthera Anti-Snoring Device Panthera Dental Inc. Guy Bernard Bantsiele
K143057 12/03/2014 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS Theresa Poole
K143488 12/17/2014 InFill Graft Delivery System PINNACLE SPINE GROUP, LLC Rebecca K Pine
K143248 12/19/2014 Reform Pedicle Screw System PRECISION SPINE, INC. MICHAEL C. DAWSON
K143330 12/15/2014 BruxZir Anterior PRISMATIK DENTALCRAFT, INC. Armin Zehtabchi
K142738 12/19/2014 artus HSV-1/2 QS-RGQ MDx Kit QIAGEN Lindsey Howard
K143206 12/10/2014 AmpliVue Bordetella Assay QUIDEL CORPORATION RONALD H. LOLLAR
K142718 12/17/2014 Radlink GPS RADLINK, INC. Brian Kordich
K143307 12/18/2014 RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector RAYNER INTRAOCULAR LENSES LTD. Juliette Cook
K142676 12/05/2014 Siemens 3.0T PROCURE Array Coil RESONANCE INNOVATIONS LLC RANDALL JONES
K143284 12/16/2014 Elecsys Estradiol III Calcheck ROCHE DIAGNOSTICS Kelli Turner
K143342 12/19/2014 Elecsys T-Uptake Calset Roche Diagnostics Kelli Turner
K142721 12/17/2014 cobas MRSA/SA Test ROCHE MOLECULAR SYSTEMS, INC. Wilk von Gustedt
K142789 12/16/2014 A1c iGear System Sakae Corporation Shinji Nakayama
K142701 12/19/2014 SMD Sr90-1 Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. Laurence Marsteller
K143264 12/09/2014 H60 V2.00 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD Kyeong-Mi Park
K143221 12/05/2014 Schoelly Laparoscope Schoelly Fiberoptic Gmbh Sandra Baumann
K142715 12/16/2014 Sensor Medical Family of Vitrectomy Lenses and Products Sensor Medical Technology, LLC Louise Culham
K143195 12/22/2014 Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Yanhong Bai
K143376 12/23/2014 ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO
K143194 12/05/2014 ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO
K142758 12/05/2014 ADVIA Centaur HAV total assay SIEMENS HEALTHCARE DIAGNOSTICS, INC. Philip Liu
K143352 12/24/2014 IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Sara Kastrup
K143254 12/10/2014 eSie Apps Suite SIEMENS MEDICAL SOLUTIONS USA, INC. NANCY BURKE
K143205 12/05/2014 Viscoelastic Injector Sight Sciences, Inc. Paul Badawl
K142807 12/22/2014 ANTHEM PS Total Knee System Smith & Nephew, Inc. Samir Ibrahim
K143050 12/18/2014 VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K142661 12/11/2014 Bi-Portal Bone Graft Delivery Device Spinal Surgical Strategies, LLC Jeffrey Kleiner
K143403 12/18/2014 Threshold Pedicular Fixation System Spineology, Inc. Tim Crabtree
K142699 12/31/2014 LITe Plate System STRYKER CORPORATION KRISTEN MEANY
K143138 12/22/2014 AxSOS 3 Ti Locking Plate System Stryker Trauma AG ELIJAH N WREH
K142630 12/23/2014 Instru-Safe Instrument Protection System Summit Medical Inc. Nicole Dove
K142777 12/19/2014 Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflex Medical, Inc. Ashlea Ricci
K142735 12/21/2014 The Optilite IgG3 kit THE BINDING SITE GROUP LTD Andrea Thomas
K142901 12/19/2014 RhythmView Workstation Topera, Inc. Dennis Pozzo
K143296 12/16/2014 AIA-PACK C-Peptide Control Set Tosoh BioScience, Inc. Robert L Wick
K143144 12/03/2014 ST AIA-PACK PROG II Calibrator Set Tosoh BioScience, Inc. Robert L Wick
K143407 12/23/2014 Klassic HD Hip System Total Joint Othopedics, Inc. Chris Weaber
K143224 12/19/2014 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. Peter J. Coronado
K142560 12/11/2014 Varian Head Frame VARIAN MEDICAL SYSTEMS, INC. Peter J Coronado
K142910 12/19/2014 Legacy BX Venus Concept USA Inc. Lilia Schlosberg
K143079 12/04/2014 Endovascular Stent Planning Software VITAL IMAGES, INC. Parthiv Shah
K142919 12/16/2014 EXA Viztek LLC Josip Cermin
K143328 12/19/2014 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip Volcano AtheroMed, Inc. Jean Chang
K143025 12/05/2014 TOTAL COMPRESSION PLATING SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. Jeanine Redden
K142771 12/22/2014 Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Xuanhua Metallurgical Industry CO., LTD Yanlong Dong
K143052 12/16/2014 Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. Wen-Han Chen
K142787 12/22/2014 Zimmer Persona Personalized Knee System ZIMMER, INC. KEITH PROCTOR
K142915 12/03/2014 ZOLL X Series ZOLL MEDICAL CORPORATION Tammay Shukla


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