FDA 510(k) Decisions During February, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K140649 12/29/2014 VECTRIX EXTERNAL FIXATOR 3D MEDICAL CONCEPTS, LLC BEVERLY LAIRD
K130864 02/06/2014 C-MAX+ (PLUS) AAT ALBER ANTRIEBSTECHNIK GMBH STEFANIE D BANKSTON
K130255 02/28/2014 HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS ABBOTT LABORATORIES JUDITH R WALLACH
K133115 02/27/2014 COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK ABBOTT MEDICAL OPTICS INC Rosanne Yetemian
K142415 12/19/2014 Hi-Torque JET Guide Wire Family ABBOTT VASCULAR INC. JANET BENSON
K140160 02/20/2014 RELIEVA SCOUT SINUS DILATION SYSTEM ACCLARENT, INC. JAMES P GARVEY, II
K131146 02/10/2014 ARTASSIST AND VENASSIST ACI MEDICAL, LLC ED ARKANS
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.
K132832 02/13/2014 ACTIVAPATCH ET IONTOPHORESIS PATCH ACTIVATEK INC. JAMAL YANAKI
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
K130890 02/06/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) AIR PLASTIC CO., LTD. CHU XIAOAN
K133394 02/06/2014 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K133450 02/14/2014 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K130401 02/07/2014 ALERTWATCH: OR ALERTWATCH LLC DONNA-BEA TILLMAN
K142672 12/03/2014 AliveCor Heart Monitor ALIVECOR, INC. Albert Boniske
K130921 02/06/2014 ALIVECOR HEART MONITOR OTC ALIVECOR, INC. MICHAEL RIGHTER
K140680 12/12/2014 LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM ALPINE BIOMED APS Seamus O'Connor
K133296 02/14/2014 XCATH ALSEAL YOLANDA SMITH
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
K132925 02/11/2014 SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK AMENDIA, INC. JOHN KAPITAN
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
K131066 02/21/2014 AXIOM REG ANTHOGYR SAS THERESE CANDAU
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
K140036 02/06/2014 APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH APTUS ENDOSYSTEMS, INC. BURT GOODSON
K141969 12/19/2014 FIRSTSTIC N INTRODUCER ARGON MEDICAL DEVICES, INC SUZANNE CHEANG
K133119 02/28/2014 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS ARJOHUNTLEIGH POLSKA SP Z.O.O. DAVID MOYNHAM
K133854 02/27/2014 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. LEON BROWN, II
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
K132496 02/26/2014 ARTHROSURFACE TOEMOTION 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
K133462 02/07/2014 DUOCENTRIC REVERSED SHOULDER PROSTHESIS ASTON MEDICAL CATHERINE GLOSTER
K132422 02/13/2014 PALS PLATINUM NEUROSTIMULATION ELECTRODES AXELGAARD MFG. CO., LTD. DAN P JEFFERY
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
K133948 02/21/2014 BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT BARD PERIPHERAL VASCULAR, INC. SARAH MCCARTNEY
K143067 12/22/2014 Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC. JON P. HUNT
K133242 02/14/2014 STELLARIS VISION ENHANCEMENT SYSTEM BAUSCH & LOMB TIMOTHY W CAPEHART
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
K132909 02/14/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) Becton, Dickinson and Company KATIE COYLE
K142340 12/02/2014 Infrared Therapy System Beijing Huatai Healthcare Technology Co., Ltd. Bingxian Zheng
K133158 02/28/2014 ND: YAG LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
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
K132457 02/21/2014 FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER BIOCARE ASIA CORPORATION LTD. SHUCHI CHANG
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
K132958 02/19/2014 MEDICINAL LEECHES BIOPHARM (UK) LTD. BETHANY SAWYER
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
K130616 02/07/2014 MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES BIOPSYBELL S.R.L. WILLER GHELFI
K132613 02/05/2014 SONILASE LIGHT THERAPY DEVICE BIORENEW LABS, LLC SUSAN ANTHONEY
K133509 02/21/2014 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO Biotest Medical Corp. ROBERT NAWY
K142379 12/05/2014 Passeo-35 PTA Catheter BIOTRONIK, INC. Jon Brumbaugh
K140104 02/13/2014 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL Rebecca K Pine
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
K132810 02/28/2014 GLADIATOR ELITE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. BETH TOROK
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
K132192 02/14/2014 BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K142108 12/16/2014 RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS BRAINLAB AG ALEXANDER SCHWIERSCH
K132763 02/28/2014 ADVANCED VIEWER BRAINLAB, AG ALEXANDER SCHWIERSCH
K133385 02/26/2014 LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE BRONCUS MEDICAL INC ROBIN BUSH
K143208 12/09/2014 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc Laurie Sang
K133335 02/14/2014 POWERPORT IMPLANTABLE PORT C.R. BARD, INC. AMY HONEY
K132064 02/28/2014 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K122758 02/12/2014 POWERHEART G5 AED CARDIAC SCIENCE CORPORATION KATHLEEN ROBERTS
K133293 02/12/2014 15 FR. TANDEMHEART ARTERIAL CANNULA CARDIACASSIST INC. Greg Johnson
K140118 02/25/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE CARDICA, INC. VEE ARYA
K140170 02/19/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE CARDICA, INC. VEE ARYA
K122632 02/11/2014 GUAVA II CARDIOCOMM SOLUTIONS, INC. JONATHAN WARD
K140015 02/05/2014 CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER CARDIOSOLUTIONS INC CHRISTINE SANTAGATE
K133999 02/28/2014 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. BLAIR BUTH
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
K132824 02/06/2014 CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION CARESTREAM HEALTH,INC. DAVID C FURR
K133476 02/12/2014 SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION CARL ZEISS MEDITEC AG SARAH HARRINGTON
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
K134004 02/14/2014 VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS LOLITA D FORBES
K133447 02/24/2014 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K140592 12/17/2014 CERAGEM AUTOMATIC THERMAL MASSAGER CERAGEM INTERNATIONAL, INC. E.J. Smith
K131727 02/28/2014 CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. HAKSUNG KIM
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
K133625 02/24/2014 AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & Codman & Shurtleff, Inc. HANNAH FOLEY
K141721 12/22/2014 BOVINE PERICARDIUM PATCH COLLAFIRM LLC Surendra P Batra
K140116 02/12/2014 RESTORELLE Y CONTOUR MESH COLOPLAST A/S TIM CRABTREE
K133177 02/25/2014 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. RHODA SANTOS
K142404 12/11/2014 iTotal Posterior Stabilized (PS) Knee Replacement System ConforMIS Inc. Amita Shah
K131552 02/12/2014 CONVENTUS DRS CONVENTUS ORTHOPAEDICS KENT LIND
K140033 02/27/2014 TARGET3D FUSION CONVERGENT LIFE SCIENCES, INC. DINESH KUMAR
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
K131772 02/20/2014 CANTATA(R) 2.9 MICROCATHETER COOK, INC. JENNIFER A RICHARDSON
K133701 02/06/2014 NUVANT MCT SYSTEM CORVENTIS, INC. CHERYL SWANSON
K130320 02/04/2014 BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW COVIDIEN ELIZABETH MALO
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
K131252 02/24/2014 PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM COVIDIEN MICHAEL AYMAMI
K142643 12/15/2014 Stabilynx PEEK Suture Anchor D3 DC, LLC /Stabilynx, Inc Mike Rosenthal
K133858 02/28/2014 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K131909 02/24/2014 DALTON LIFT CHAIR DALTON INSTRUMENT CORP. MEI LEIN
K133267 02/11/2014 DANA REUSABLE TEST PACK DANA PRODUCTS, INC. HARRY BALA
K132389 02/25/2014 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED DANIEL & DANIEL CONSULTING MICHAEL A DANIEL
K142329 12/15/2014 BBS REVOLUTION dBMEDx INC. DAVE SHINE
K131033 02/12/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DECENT PLASTIC CO., LTD. CHU XIAOAN
K143378 12/29/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K133090 02/28/2014 OXICARE FINGERTIP PULSE OXIMETER DELBIO INCORPORATION ERICA LI
K133794 02/04/2014 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TATYANA KORSUNSKY
K131292 02/03/2014 DEROYAL SPINE SPACER SYSTEM DEROYAL INDUSTRIES, INC. KAREN E WARDEN, PHD
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
K130511 02/10/2014 CITRISOL ACID CONCENTRATE DIASOL, INC. MONICA ABELES
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
K130580 02/25/2014 RETRACTION PASTE DMG USA, INC. PAMELA PAPINEAU, RAC
K141756 12/12/2014 INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc. KAREN PROVENCHER
K132842 02/21/2014 FLAATZ 600 SERIES (FLAATZ 600/601) DRTECH CORP. CHOUL-WOO SHIN
K132140 02/04/2014 DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER DUTECK INDUSTRIAL CO., LTD. JOSEPH CHEN
K132480 02/24/2014 AIR-FLOW HANDY 3.0 PERIO E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K133517 02/26/2014 NEMUS 2 SYSTEM EB NEURO, S.P.A. ALLISON SCOTT, RAC
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
K131503 02/25/2014 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. CHERRY SUN
K132313 12/05/2014 PESSARY EIS CORPORATION YANG HO DONG
K131882 02/12/2014 GEODESICEEG SYSTEM 400 SERIES (GES 400) ELECTRICAL GEODESICS, INC. LINDA J BOVARD
K140178 02/27/2014 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K132949 02/20/2014 PELLEFIRM ELLMAN INTERNATIONAL, INC. Alison Sathe
K133536 02/26/2014 EMERGE MEDICAL BONE PLATE SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K142194 12/19/2014 CytoSure Urinary Access System Emmy Medical Christine G Santagate
K133359 02/11/2014 ENDORINGS ENDO-AID, INC. JANICE M HOGAN
K132839 02/06/2014 FUSE 1C COLONOSCOPY SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K140796 12/02/2014 MEDUSA VASCULAR PLUG, ENDOSHAPE, INC. MICHAEL PARMENTER
K141330 12/15/2014 ENDO-CORD ENROXTECH, INC. LEWIS WARD
K133647 02/27/2014 EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K143186 12/18/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K131990 02/21/2014 OXYGEN GENERATOR LIQUEFIER - (OGL) ESSEX CRYOGENICS OF MISSOURI, INC. PAUL DRYDEN
K132580 02/28/2014 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC. PETER CECCHINI
K140224 12/09/2014 EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) EUROIMMUN US MICHAEL LOCKE
K131791 02/26/2014 IFA 40: HEP-20-10 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
K140063 02/11/2014 EQUINOXE EXTRA SHORT HUMERAL HEAD EXACTECH, INC. PATRICK HUGHES
K132582 02/12/2014 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM EXACTECH, INC. PATRICK HUGHES
K131266 02/14/2014 TREZ_HD EXCEL-TECH LTD. (XLTEK) DANIEL RAMIREZ
K131626 02/26/2014 EXCELERON BACTERIAL FILTERS EXCELERON MEDICAL BERNARD HORWATH
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
K140254 02/26/2014 EZONO 4000 EZONO AG GRAHAM COX
K130723 02/07/2014 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL FAMIDOC TECHNOLOGY CO., LTD REANNY WANG
K131196 02/20/2014 INFANT PHOTOTHERAPY BILITRON SKY 5006 FANEM LDA TARA CONRAD
K133666 02/05/2014 RT016 INSPIRATORY FILTER FISHER & PAYKEL HEALTHCARE LTD. ELIZABETH GOLDSTEIN
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
K130891 02/18/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES FRIEND PLASTIC CO., LTD. CHU XIAOAN
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
K133533 02/12/2014 LOGIQ E GE HEALTHCARE BRYAN BEHN
K142288 12/03/2014 MAC 800 Resting ECG Analysis System GE MEDICAL SYSTEMS CHINA CO., LTD. Sun YanLi
K133576 02/21/2014 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
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
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K141279 12/03/2014 WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR WANGHUI GLOVE CO., LTD. CHU XIAOAN
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K141304 12/12/2014 YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR YONGXIN HEALTHCARE CO., LTD. CHU XIAOAN
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K142271 12/19/2014 Zavation Z-Link Lumbar Zavation, LLC Lawrence Walker
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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
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