FDA 510(k) Decisions During December, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K140649 12/29/2014 VECTRIX EXTERNAL FIXATOR 3D MEDICAL CONCEPTS, LLC BEVERLY LAIRD
K142415 12/19/2014 Hi-Torque JET Guide Wire Family ABBOTT VASCULAR INC. JANET BENSON
K142391 12/22/2014 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) ACON LABORATORIES, INC. QIYI XIE
K140772 12/19/2014 AEROSURE MEDIC Actegy Ltd John j Smith, M.D., J.D.
K140977 12/22/2014 EVOTECH ECR ADVANCED STERILIZATION PRODUCTS REUBEN LAWSON
K141693 12/19/2014 Tyvek« Pouch/Roll with STERRAD« Chemical Indicator ADVANCED STERILIZATION PRODUCTS SUN CHOI
K142122 12/04/2014 RADAR VASCULAR COMPRESSION DEVICE ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
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
K142528 12/22/2014 AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm Agent Medical, LLC Scott Munday
K142672 12/03/2014 AliveCor Heart Monitor ALIVECOR, INC. Albert Boniske
K140680 12/12/2014 LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM ALPINE BIOMED APS Seamus O'Connor
K141529 12/03/2014 ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S LORI E ADELS
K142264 12/08/2014 Valeo C Spacer System, Valeo II C IBF Device Amedica Corp. William D Jordan
K142333 12/18/2014 SMART LABEL, PROPOFOL AMERICAN I.V. PRODUCTS, INC dba AIV, INC SHANNON HOUCHEN
K142285 12/01/2014 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz AmeriWater Brian R Bowman
K141213 12/10/2014 AMERIWATER OZONE DISINFECTION SYSTEM AMERIWATER BRIAN BOWMAN
K142607 12/11/2014 AngioVac Circuit ANGIODYNAMICS Gary Barrett
K140931 12/05/2014 IGROW II HAIR GROWTH SYSTEM APIRA SCIENCE, INC. RAYMAND R BLANCHE
K142427 12/23/2014 TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 APPLIED MEDICAL RESOURCES AEREE LEE
K141969 12/19/2014 FIRSTSTIC N INTRODUCER ARGON MEDICAL DEVICES, INC SUZANNE CHEANG
K140855 12/18/2014 ARTHREX SUTURETAK SUTURE ANCHORS ARTHREX, INC. DAVID L ROGERS
K141695 12/30/2014 ACROSSPINE PEDICLE SCREW SYSTEM ARTHRO-DIF RICH JANSEN
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
K141920 12/23/2014 Wrist Hemiarthroplasty System ARTHROSURFACE, INC. DAWN J WILSON
K133924 12/03/2014 ENDOLUMINAL OCCLUSION SYSTEM (EOS) ARTVENTIVE MEDICAL GROUP, INC Roberta Hines
K142619 12/18/2014 Snap Insulin Pump System ASANTE SOLUTIONS, INC EDWARD SINCLAIR
K142124 12/31/2014 AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM ASEPTICO, INC. CHERIE TREGONING
K140838 12/05/2014 IV ADMINISTRATION SET WITH HAND PUMP B. BRAUN MEDICAL, INC. ANGELA J CARAVELLA
K133994 12/01/2014 SIVR56-T KIT BARCO N.V. LIEVEN DE WANDEL
K143067 12/22/2014 Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC. JON P. HUNT
K142373 12/22/2014 Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst BECKMAN COULTER, INC. Ryan Severson
K142362 12/19/2014 Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. BECKMAN COULTER, INC. RYAN SEVERSON
K141474 12/18/2014 BECTON DICKINSON INTELLIPORT SYSTEM BECTON DICKINSON & CO. DANIEL OLIVIER
K141810 12/10/2014 BD BACTEC PLUS ANAEROBIC/F (PLASTIC) Becton, Dickinson and Company Paul Swift
K142340 12/02/2014 Infrared Therapy System Beijing Huatai Healthcare Technology Co., Ltd. Bingxian Zheng
K140285 12/04/2014 B TRAVELSAVVY SHARPS CONTAINER BELLEGROVE MEDICAL SUPPLY, INC. WAYNE MORSE
K142463 12/18/2014 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc. Janet Krevolin, PhD
K142204 12/19/2014 Bioceptive Suction Cervical Retractor Bioceptive Inc. Steward B. Davis, M.D.
K141893 12/18/2014 VIBRANCE KEGEL DEVICE (VKD) BIOINFINITY (M)SDN.BHD. Carrie Hetrick
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
K140669 12/11/2014 G7 OSSEOTI ACETUBLAR SHELLS BIOMET, INC. BECKY EARL
K133047 12/18/2014 RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K142379 12/05/2014 Passeo-35 PTA Catheter BIOTRONIK, INC. Jon Brumbaugh
K133333 12/31/2014 UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT BLUE OCEAN MEDICAL PRODUCT, LLC. E.J. Smith
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
K142108 12/16/2014 RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS BRAINLAB AG ALEXANDER SCHWIERSCH
K143208 12/09/2014 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc Laurie Sang
K141936 12/29/2014 MICROBLAB, MICROLOOP CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K141064 12/04/2014 VESOFLOW PLUS DVT COMPRESSION DEVICE CAREMED SUPPLY, INC. MICHAEL LEE
K142490 12/15/2014 ProxiFuse Hammer Toe Device Cartiva, Inc. Richard Knostman
DEN140009 12/18/2014 AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC JENNIFER ENGLUND
K141092 12/04/2014 MARK3 CAVEX HOLLAND B.V R, WOORTMAN
K140592 12/17/2014 CERAGEM AUTOMATIC THERMAL MASSAGER CERAGEM INTERNATIONAL, INC. E.J. Smith
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
K142429 12/24/2014 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable Codman & Shurtleff, Inc Hannah Foley
K141721 12/22/2014 BOVINE PERICARDIUM PATCH COLLAFIRM LLC Surendra P Batra
K142404 12/11/2014 iTotal Posterior Stabilized (PS) Knee Replacement System ConforMIS Inc. Amita Shah
K142688 12/19/2014 Echotip Procore HD Ultrasound Biopsy Needle COOK IRELAND LTD Nora O'Connor
K140593 12/15/2014 ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE COOK, INC. LARRY D POOL
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
K141479 12/23/2014 KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS COVIDIEN TEGHPAL SINGH
K142643 12/15/2014 Stabilynx PEEK Suture Anchor D3 DC, LLC /Stabilynx, Inc Mike Rosenthal
K142329 12/15/2014 BBS REVOLUTION dBMEDx INC. DAVE SHINE
K143378 12/29/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K142168 12/04/2014 NATURE'S BOND 600 AND NATURE'S BOND 603 DEVON MEDICAL PRODUCTS, INC. Ruth Wu
K141575 12/15/2014 PLAC TEST FOR LP-PLA2 ACTIVITY DIADEXUS, INC. Lorry Weaver Huffman
K142132 12/12/2014 POOL NORM Diagnostics Stago S.A.S. MARIE COMPAGNON-RIOBE
K141463 12/10/2014 LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS DiaSorin Inc. CAROL A DEPOUW
K141586 12/30/2014 OWL CANNULAE DIROS TECHNOLOGY, INC. GEORGE DARMOS
K141054 12/10/2014 DISTAL ACCESS TORQUE DEVICE DISTAL ACCESS, LLC CAROL STAMP
K140663 12/12/2014 THERASNORE DISTAR, LLC JANEEN VILVEN-DOGGETT
K141756 12/12/2014 INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc. KAREN PROVENCHER
K140734 12/15/2014 NEXTGEN ALTIUS OCT SYSTEM EBI, LLC TED KUHN
K142514 12/18/2014 UniWeb 8.0 EBM Technologies Incorporated John Su
K142173 12/30/2014 NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE ECOLAB, INC. JENNIFER WILLNER
K132313 12/05/2014 PESSARY EIS CORPORATION YANG HO DONG
K142194 12/19/2014 CytoSure Urinary Access System Emmy Medical Christine G Santagate
K140796 12/02/2014 MEDUSA VASCULAR PLUG, ENDOSHAPE, INC. MICHAEL PARMENTER
K141330 12/15/2014 ENDO-CORD ENROXTECH, INC. LEWIS WARD
K143186 12/18/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K140224 12/09/2014 EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) EUROIMMUN US MICHAEL LOCKE
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
K142365 12/05/2014 Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack FOCUS DIAGNOSTICS Sharon Young
K141009 12/16/2014 FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc. Chris Yerger
K141691 12/17/2014 GEN_3 FREE WHEELCHAIR MISSION SHARON ROCKWELL
K142521 12/01/2014 Synapse 3D Liver and Kidney Analysis FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC. JYH-SHYAN LIN
K140436 12/23/2014 ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN
K141557 12/08/2014 HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR GALLINI MEDICAL DEVICES, SRL ARTHUR S GODDARD
K142288 12/03/2014 MAC 800 Resting ECG Analysis System GE MEDICAL SYSTEMS CHINA CO., LTD. Sun YanLi
K142361 12/05/2014 Discovery MR750 3.0T GE MEDICAL SYSTEMS, LLC Jenny Wong
K140665 12/08/2014 GenPrime Snap-Top Split Key Cup GENPRIME, INC Darby McLean
K140284 12/17/2014 GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD. HILA DEBBY
K140668 12/19/2014 PLATINUMGMT IPL SYSTEM CLOUD GLOBAL MEDICAL TECHNOLOGY S.L. Derliz David Diaz Sanchez
K142409 12/05/2014 Vinyl Co-Polymer Powder Free Examination Gloves GRAND WORK PLASTIC PRODUCTS CO., LTD. DENG ZHANYONG
K141412 12/03/2014 STERILUCENT SELF-SEAL STERILIZATION POUCH GS MEDICAL PACKAGING, INC. PETER KALKBRENNER
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
K142164 12/17/2014 MANIPULATOR; MANIPULATOR PRO GYNETECH PTY. LTD. KEVIN MACDONALD
K142289 12/31/2014 PK Spatula Gyrus ACMI Inc. Neil Kelly
K142154 12/19/2014 PK NEEDLE GYRUS ACMI, INC. NEIL KELLY
K141862 12/02/2014 HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE H2 Inc. Feng-Yu Lee
K141712 12/18/2014 KIMGUARD ONE STEP STERILIZATION WRAP Halyard Health Thomas Kozma
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
K140989 12/22/2014 POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD CHARLES SHEN
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
K133800 12/19/2014 ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI HGI INDUSTIRES CONNIE ARAPS, PHD
K141161 12/20/2014 ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) HORIBA ABX SAS FERRER CAROLINE
K142433 12/08/2014 Hospira Extension Set Hospira, Inc. David Blonski
K141287 12/03/2014 HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR HUIKANG GLOVE CO., LTD. CHU XIAOAN
K141105 12/04/2014 PULSE OXIMETER HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. LI ZHANG
K143339 12/19/2014 Mini me ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) BOBAE KIM
K140860 12/16/2014 ImmersiveTouch3 and MicrovisTouch IMMERSIVE TOUCH PRASHANT BANERJEE
K140554 12/19/2014 IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET IMMUNODIAGNOSTIC SYSTEMS LTD. MICK HENDERSON
K141764 12/18/2014 TRISTAR BONE GRAFT FIXATION SYSTEM IMPLADENT, LTD. MAURICE VALEN
K140926 12/03/2014 INMODE WMFACE DEVICE INMODE MD LTD. AHAVA STEIN
K142638 12/19/2014 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) InnovaQuartz LLC Stephen Griffin
K142477 12/15/2014 Intact Advance and Intact Excision XL, Intact BLES INTACT MEDICAL CORPORATION JOHN VACHA
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
K141701 12/05/2014 I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] ISOAID, L.L.C. MARY ANN GREENAWALT
K140657 12/04/2014 CUROS RED PORT PROTECTOR IVERA MEDICAL, INC. DON CANAL
K140705 12/05/2014 NAVIGABLE BRAIN BIOPSY CANNULA SET IZI MEDICAL PRODUCTS QIANG CAO
K130447 12/22/2014 SPEEDY FLAP SYSTEM Jeil Medical Corporation Jieun Kim
K142043 12/18/2014 INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA JENSEN INDUSTRIES, INC. JORDAN SCHRECK
K140202 12/12/2014 TRAUSIM DENTAL IMPLANT SYSTEM JIANGSU TRAUSIM MEDICAL INSTRUMENT LUO ZHICONG
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
K140847 12/05/2014 CARDIOSPY ECG HOLTER SYSTEMS LABTECH KFT. ZSOLT KATONAI
K140536 12/17/2014 HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE LAKE REGION MEDICAL KENNETH WALSH
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
K141727 12/18/2014 DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) LIAONING UPCERA CO.,LTD CHARLES SHEN
K142326 12/23/2014 HP Tissue Matrix LifeCell Corporation Mira Leiwant
K132407 12/19/2014 VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) LIFEWATCH TECHNOLOGIES LTD ASHER KASSEL
K143145 12/04/2014 SafeAir Smoke Pencil LiNA Medical ApS Anne Klitgard
K142682 12/22/2014 The Lipogems System Lipogems International SpA Carlo Russo
K140290 12/02/2014 STOPLOSS JONES TUBE LJT SURGICAL LTD PATSY J TRISLER, JD, RAC
K143119 12/18/2014 LT-300 Video Colposcope Lutech Industries, Inc. Ron Vachula
K142069 12/02/2014 GMK EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K141926 12/19/2014 INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDELA AG ADRIENNE LENZ
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
K142022 12/19/2014 MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES MEDLINE RENEWAL RICHARD D WYNKOOP
K141420 12/18/2014 FASTFORWARD MEDSHAPE, INC JEREMY BLAIR
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
K141632 12/04/2014 ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. KRISTI FRISCH
K142611 12/31/2014 TYRX Neuro Absorbable Antibacterial Envelope MEDTRONIC TYRX, INC. REGINA NOVAK
K140091 12/12/2014 XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM MEGAGEN IMPLANT CO., LTD SUSAN PARK
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
K142051 12/17/2014 PRELUDE PLASTIC JACKETED GUIDE WIRE MERIT MEDICAL SYSTEMS INC. MICHAEL O'SULLIVAN
K141295 12/16/2014 MERIT HYDROPHILIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC. MICHAEL O'SULLIVAN
K143429 12/22/2014 Passage Hemostasis Valve MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K140589 12/03/2014 STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR MESA LABORATORIES, INC. Kurt McCauley
DEN130004 12/18/2014 MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. ROBERT J CHIN
K141020 12/03/2014 SURVEYOR S4 MOBILE MONITOR MORTARA INSTRUMENT, INC. AMY YANG
K142342 12/18/2014 NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) Nacrous Plastic Co., Ltd WANG LI
K142951 12/10/2014 MD210C3 21.3 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD. Satoru Kotani
K142419 12/16/2014 Mini and Micro Fragments Reconstruction System-NEOFIX NEOORTHO PRODUCTOS ORTHOPEDICOS S/A Mariana de Oliveira Quinzani
K142697 12/23/2014 NExCT 7 NEUROLOGICA CORPORATION Ninad Gujar
K133373 12/03/2014 CLEARVIEW NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K142388 12/05/2014 Neo Total Knee System New Era Orthopedics, LLC Craig Corrance
K142502 12/23/2014 ALIANS ULNA LOCKING PLATING SYSTEM NEWCLIP TECHNICS Ga?lle LUSSORI
K143197 12/23/2014 Nice1 NICE RECOVERY SYSTEMS, LLC MICHAEL ROSS
K140440 12/19/2014 NORIS MEDICAL DENTAL IMPLANTS SYSTEM NORIS MEDICAL LTD. RAANAN ALONI
K142111 12/19/2014 ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE NOVATSEP GILLES AUDIC
K142737 12/18/2014 MAS PLIF Fixation system NUVASIVE, INCORPORATED OLGA LEWIS
K142328 12/23/2014 nvc NVISION BIOMEDICAL TECHNOLOGIES, LLC BRIAN KIESER
K141752 12/19/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K140624 12/10/2014 HICURA HAND INSTRUMENTS OLYMPUS WINTER & IBE GMBH SHERI L MUSGNUNG
K142917 12/01/2014 BP652N (HEM-6300-Z) OMRON Healthcare, Inc Renee Thornborough
K141978 12/03/2014 MAXPOWER RELIEF OMRON HEALTHCARE, INC. PAUL DRYDEN
K142671 12/05/2014 ONEFIT HIP PLANNER ONEFIT MEDICAL JULIEN SIMON
K142639 12/16/2014 StitchKit ORIGAMI SURGICAL LLC Patrick Culligan
K141611 12/05/2014 LYTHOS DIGITAL IMPRESSION SYSTEM ORMCO CORP. COURTNEY CLARK
K142146 12/11/2014 IBIS PEDICLE SCREW SYSTEM ORTHO DEVELOPMENT CORP. MIKE ENSIGN
K143069 12/22/2014 HEMASORBPLUS press Resorable Hemostatic Bone Putty ORTHOCON, INC. Howard L Schrayer
K142052 12/05/2014 ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT ORTHOFIX SRL CHERYL WAGONER
K141760 12/08/2014 ORTHOFIX GALAXY WRIST ORTHOFIX SRL CHERYL WAGONER
K143125 12/10/2014 Orthofix True Lok Hexapod System VI.3 Orthofix Srl Gianluca Ricadona
K142081 12/12/2014 CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES OSPREY MEDICAL, INC. MELANIE HESS
K140978 12/18/2014 OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM OSTEOMED Ally Baduel
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
K142126 12/09/2014 EP NAVIGATOR REL. 5.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LISELOTTE KORNMANN
K142430 12/19/2014 LIFEPAK 15 monitor/defibrillator PHYSIO-CONTROL, INC. Sylvia Lemke
K141282 12/02/2014 PGS 5.5 MM CANNULATED PEDICLE SCREW PINNACLE SPINE GROUP MEREDITH MAY
K143488 12/17/2014 InFill Graft Delivery System PINNACLE SPINE GROUP, LLC Rebecca K Pine
K142041 12/19/2014 POROSTEON PHUSION METAL CERVICAL CAGE POROSTEON, INC. ROBERT A POGGIE, PHD
K142378 12/18/2014 Interspinous Plate System Precision Spine, Inc. Michael C. Dawson
K143248 12/19/2014 Reform Pedicle Screw System PRECISION SPINE, INC. MICHAEL C. DAWSON
K142471 12/01/2014 Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip Pressure Point Inc. Joseph DiLustro
K140350 12/12/2014 VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL PREVENTIVE TECHNOLOGIES, INC. KENNETH S PETERSON
K143330 12/15/2014 BruxZir Anterior PRISMATIK DENTALCRAFT, INC. Armin Zehtabchi
K133502 12/03/2014 5000Z FIREFLY SYSTEM PRIZM MEDICAL, INC. CARL BEAURLINE
K141389 12/11/2014 SAPPHIRE INFUSION PUMP Q CORE MEDICAL LTD Rhona Shanker
K142738 12/19/2014 artus HSV-1/2 QS-RGQ MDx Kit QIAGEN Lindsey Howard
K142384 12/12/2014 DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) QUALIMED SRL Tereza Uhrova
K143206 12/10/2014 AmpliVue Bordetella Assay QUIDEL CORPORATION RONALD H. LOLLAR
K141775 12/16/2014 SOFIA (R) STREP A+ FIA QUIDEL CORPORATION JOHN D TAMERIUS
K141795 12/08/2014 BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 R & D BATTERIES, INC. KAREN MANLEY
K142718 12/17/2014 Radlink GPS RADLINK, INC. Brian Kordich
K140971 12/08/2014 LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K143307 12/18/2014 RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector RAYNER INTRAOCULAR LENSES LTD. Juliette Cook
K131643 12/17/2014 DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT RECKITT BENCKISER, LLC SAPANA AMIN
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
K142089 12/17/2014 ACCU-CHEK AVIVA EXPERT SYSTEM ROCHE DIAGNOSTICS CORPORATION Greg Mondics
K141925 12/09/2014 TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics Operations (RDO) PATRICK STIMART
K142721 12/17/2014 cobas MRSA/SA Test ROCHE MOLECULAR SYSTEMS, INC. Wilk von Gustedt
K133496 12/03/2014 X TWIN SYSTEM ROESYS GMBH JOCHEN DYSZBALIS
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
K142492 12/17/2014 GM60A-32S, GM60A-40S SAMSUNG ELECTRONICS CO., LTD. KIM CHULSIN
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
K141366 12/17/2014 VIDEO BRONCHOSCOPE SYSTEM SCHOLLY FIBEROPTIC GMBH SANDRA BAUMANN
K142180 12/12/2014 TELESENSE SCOTTCARE CORPORATION SNEHRAJ MERCHANT
K142488 12/18/2014 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene SeaSpine, Inc. Michelle Willis
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
K142049 12/18/2014 MULTIX FUSION VA30 & VA40 SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K140920 12/03/2014 SYNGO.CT COLONOGRAPHY SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
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
K142474 12/19/2014 S12 Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED TOKI WU
K133218 12/10/2014 Crystal «; Mosaic «; Vertu « SPINAL ELEMENTS, INC. JULIE LAMOTHE
K142661 12/11/2014 Bi-Portal Bone Graft Delivery Device Spinal Surgical Strategies, LLC Jeffrey Kleiner
K141135 12/01/2014 JULIET LL SPINEART FRANCK PENNESI
K143403 12/18/2014 Threshold Pedicular Fixation System Spineology, Inc. Tim Crabtree
K141046 12/24/2014 MIDI-SRS SRMC CO., LTD Priscilla Chung
K142235 12/18/2014 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St. Jude Medical ZACHARY PRICE
K142239 12/18/2014 CPS Direct MediGuide Enabled outer catheter St. Jude Medical Geena George
K140793 12/17/2014 NANOSTIM INTRODUCER KIT ST. JUDE MEDICAL, INC. HASSAN LABAY
K141530 12/18/2014 VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS STEREOTAXIS, INC. DIANA HORWITZ, PH.D., RAC
K142407 12/24/2014 Straight Stud Attachment Sterngold Dental, LLC Maria Rao
K141962 12/05/2014 XN CAL Streck Deborah Kipp
K141955 12/05/2014 XN CAL PF Streck Deborah Kipp
K141964 12/05/2014 XN CHECK Streck Deborah Kipp
K141957 12/05/2014 XN CHECK BF Streck Deborah Kipp
K142699 12/31/2014 LITe Plate System STRYKER CORPORATION KRISTEN MEANY
K142310 12/02/2014 Stryker Infrared Fluorescence (IRF) Imaging System Stryker Endoscopy Golnaz Moeini
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
K141513 12/15/2014 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM SUMMIT MEDICAL, INC. NICOLE DOVE
K142142 12/05/2014 QUALITY REPORTS SUN NUCLEAR CORPORATION JAMES LUKER
K142431 12/05/2014 WaterProof PROFILER SUN NUCLEAR CORPORATION NOEL DOWNEY
K133795 12/12/2014 SUMMED INFLATION DEVICE KIT SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD JAMES QI ZHANG
K142457 12/18/2014 Quickie, Zippie Sunrise Medical (US) LLC Laurie Roberts
K140228 12/18/2014 DISPOSABLE TRACHEAL TUBE SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD MIKE GU
K141507 12/08/2014 TWO SKIN TREATMENT SYSTEM SYNERON MEDICAL LTD. JANICE M HOGAN
K141681 12/05/2014 SYSMEX XN SERIES SYSMEX AMERICA, INC. SHARITA BROOKS
K140848 12/17/2014 LUMINESSE PORCELAIN SYSTEM TALLADIUM, INC. EDWARD R HARMS
K142343 12/10/2014 Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD RJ WANG
K141878 12/24/2014 HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K141053 12/11/2014 OVINE TISSUE MATRIX(OTM) TELA BIO, INC. DONNA STAUFFER
K141214 12/18/2014 AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS Teleflex Medical, Inc. JAMES A COCHIE
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
K140387 12/23/2014 Burn Resuscitation Decision Support System - Clinical (BRDSS-C) THE SURGEON GENERAL, DEPARTMENT OF THE ARMY KENNETH A BERTRAM, MD, PHD
K142151 12/23/2014 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific Cynthia Knapp
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
K141868 12/30/2014 TRIA FANP TRIA BEAUTY, INC. JONATHAN KAHAN
K141698 12/17/2014 STERIZONE CHEMICAL INDICATOR TSO3 INC. THOMAS RICHARDS, PH.D.
K141580 12/17/2014 STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR TSO3 INC. THOMAS RICHARDS
K141163 12/17/2014 STERIZONE STERILIZER TSO3 INC. THOMAS RICHARDS, PH.D.
K142483 12/19/2014 TurboSEAL Nasogastric Aspiration Tube TurboSEAL, L.P. DORON BESSER
K141218 12/18/2014 ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM VADISWIRE CORPORATION EDWARD (TED) WULFMAN
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
K142377 12/17/2014 The OnControl Bone Marrow Biopsy System by Vidacare VIDACARE LLC DIANA MONTEZ
K140797 12/12/2014 IPACS MEDICAL IMAGE MANAGEMENT SYSTEM VISBION LIMITED TOM FALCON
K143079 12/04/2014 Endovascular Stent Planning Software VITAL IMAGES, INC. Parthiv Shah
K140207 12/18/2014 RAPID-I KIT VITROLIFE SWEDEN AB ANTHONY T PAVEL
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
K140296 12/02/2014 CLEARLUMEN THROMBECTOMY SYSTEM WALK VASCULAR, LLC BRAD CULBERT
DEN140010 12/15/2014 PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM WALLAC OY KAY A TAYLOR
K141279 12/03/2014 WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR WANGHUI GLOVE CO., LTD. CHU XIAOAN
K142356 12/19/2014 Connex Spot Monitor,901058 Vital Signs Monitor Core WELCH ALLYN, INC. Kevin Crossen
K140667 12/15/2014 WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER WELL LEAD MEDICAL CO. LTD HAN GUANG YUAN
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
K141304 12/12/2014 YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR YONGXIN HEALTHCARE CO., LTD. CHU XIAOAN
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
K142271 12/19/2014 Zavation Z-Link Lumbar Zavation, LLC Lawrence Walker
K141303 12/12/2014 ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR ZHIDA GLOVE CO., LTD. CHU XIAOAN
K141613 12/04/2014 GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD CHU XIAOAN
K142508 12/19/2014 Powder Free Yellow Vinyl Patient Examination Gloves ZIBO HUAQI TRADING Co., Ltd Jing Li
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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