FDA 510(k) Applications Received During March, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K140695 03/19/2014 COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE MEDTRONIC INC. NISARG SHAH
K140684 03/18/2014 CLINPRO PROPHY POWDER 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K140602 03/10/2014 FLASH PENTA MB QUICK, FLASH MB QUICK 3M ESPE AG RUEDIGER FRANKE
K140607 03/10/2014 AAP LOQTEC(R) OLECRANON PLATE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K140637 03/12/2014 PEREGRINE SYSTEM INFUSION CATHETER ABLATIVE SOLUTIONS, INC. SHARON ROCKWELL
K140558 03/05/2014 PROCTIGARD ACCESS PHARMACEUTICALS, INC JEFFREY B DAVIS
K140683 03/18/2014 0180 INTUITION, 0072 PRECISION ACROMA AB DANIEL KAMM
K140619 03/11/2014 MECA XPRESSFISH ADVANDX, INC. RON EISENWINTER
K140679 03/18/2014 SUREFLEX LITHOTRIPSY LASER FIBERS AMERICAN MEDICAL SYSTEMS JOSH CLARIN
K140409 03/07/2014 FLENTS PLASTIC EYE WASH CUP APOTHECARY PRODUCTS, INC. JAMES JENKINS
K140723 03/21/2014 NOMAD MD 75K V HANDHELD X-RAY SYSTEM ARIBEX, INC. CHRISTOPHER DODGE
K140604 03/10/2014 MULTIFIX S KNOTLESS FIXATION SYSTEM ARTHROCARE CORPORATION MITCHELL DHORITY
K140521 03/04/2014 TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH ARTHROCARE CORPORATION MITCHELL A DHORITY
K140617 03/11/2014 PINIT SMALL BONE FUSION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K140715 03/21/2014 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE, INC. JUSTI N EGGLETON
K140595 03/07/2014 THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. LOUIS FRIES
K140591 03/07/2014 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR BECTON DICKINSON & CO. JOHN ROBERTS
K140682 03/18/2014 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K140788 03/31/2014 P-STIM BIEGLER GMBH PAUL DRYDEN
K140764 03/27/2014 LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K140801 03/31/2014 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM BIO-RAD LABORATORIES, INC. EBONY MCKINNIES
K140590 03/07/2014 ASTROGLIDE SENSUAL STRAWBERRY BIOFILM, INC. Sherry Castello
K140652 03/14/2014 POROUS COATED COMPREHENSIVE FRACTURE STEMS BIOMET MANUFACTURING CORP. BRIAN KINCAID
K140710 03/21/2014 BIOMET GRAFT DELIVERY SYRINGES BIOMET SPINE (AKA EBI, LLC) DEBRA L BING
K140622 03/11/2014 DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE BIOMET, INC. SUZANA OTANO
K140625 03/11/2014 ORTHOSORB LS BIOMET, INC. VICTORIA SCHEITLIN
K140577 03/06/2014 INNESIS PEEK TL CAGE BK MEDITECH CO., LTD. ELAINE DUNCAN
K140596 03/07/2014 NAVIO BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K140503 03/06/2014 FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER BOSTON SCIENTIFIC JEANNE O'TOOLE
K140630 03/11/2014 WALLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC THOMAS HIRTE
K140726 03/24/2014 CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV BOSTON SCIENTIFIC CORP. TARA PAUL
K140745 03/25/2014 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. LISA MEE
K140673 03/18/2014 INSERTION TOOL BOSTON SCIENTIFIC CORP. LISA MEE
K140733 03/26/2014 CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER BOSTON SCIENTIFIC CORPORATION MICHELLE ROEDING
K140641 03/12/2014 VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA BOSTON SCIENTIFIC CORPORATION KURTIS HUNSBERGER
K140552 03/04/2014 CADWELL SPIKE AND SEIZURE DETECTOR CADWELL JINESH JAIN
K140732 03/24/2014 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP. SAM WADE
K140635 03/12/2014 COCOON CONVECTIVE WARMING SYSTEM CARE ESSENTIALS PTY LTD BIBIANA FRANCO
K140761 03/26/2014 KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA CAREFUSION 2200 INC. JANE WEBER
K140581 03/06/2014 CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT CEDIC S.R.L. ROGER GRAY
K140782 03/31/2014 ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR CELLERATION, INC. KATHY SIMPSON
K140703 03/20/2014 OPA 30 SOLUTION CIDEN TECHNOLOGIES LLC COURTNEY CLARK
K140748 03/25/2014 ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD CO-INNOVATION BIOTECH CO.,LTD. HONG FENG
K140481 03/10/2014 COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH COLGATE-PALMOLIVE COMPANY CHARLES IRELAND
K140714 03/21/2014 PORCINE ANORGANIC BONE MINERAL COLLAGEN MATRIX, INC. PEGGY HANSEN
K140523 03/04/2014 RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM COLOPLAST A/S BRIAN SCHMIDT
K140578 03/06/2014 ARTHROSCOPIC ENERGY SYSTEM CONMED CORPORATION DIONNE SANDERS
K140658 03/14/2014 THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES CONMED CORPORATION SANDY LECLAIR
K140594 03/07/2014 BODY FAT ANALYZER AND SCALE CONMO ELECTRONIC COMPANY LIMITED CHARLES MACK
K140754 03/26/2014 COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM COOPER SURGICAL, INC. TIM LOHNES
K140548 03/04/2014 CORCAM HEART MONITOR CORCAM TECHNOLOGIA, SA JENNIFER A DAUDELIN
K140573 03/06/2014 WOUNDCLOT HEMOSTATIC GAUZE CORE SCIENTIFIC LTD. AHAVA STEIN
K140789 03/31/2014 CORMATRIX ECM FOR VASCULAR REPAIR CORMATRIX CARDIOVASCULAR, INC. BRYAN BROSSEAU
K140609 03/10/2014 RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS COVIDIEN CLARE SANTULLI
K140620 03/11/2014 SPORVIEW PLUS BI TEST PACK CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K140566 03/05/2014 SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K140585 03/07/2014 CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM CUREXO TECHNOLOGY CORPORATION GLEN EMELOCK
K140727 03/24/2014 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC. BRADLEY RENTON
K140719 03/21/2014 PICOSURE WORKSTATION CYNOSURE, INC. KEVIN O'CONNELL
K140537 03/04/2014 TENURE4G DEN-MAT HOLDINGS, LLC HELEN RAGUS
K140643 03/12/2014 GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY YAYOI FUJIMAKI
K140662 03/19/2014 FLEX ENDOSCOPIC INSTRUMENTS DESIGN STANDARDS CORP. MICHELE LUCEY
K140634 03/12/2014 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit Devon Medical, Inc. Steve XU
K140605 03/10/2014 MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC DIMA ITALIA SRL DARIO BASCIU
K140598 03/10/2014 PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC DIMA ITALIA SRL DARIO BASCIU
K140728 03/24/2014 MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR DITRON PRECISION LTD TALI HAZAN
K140461 03/05/2014 MACH LED 2MC DR. MACH GMBH & CO. KG GUDRUN BUSCH, PH.D.
K140460 03/05/2014 MACH LED 2SC DR. MACH GMBH & CO. KG GUDRUN BUSCH, PH.D.
K140702 03/20/2014 8MP COLOR LCD MONITOR, RADIFORCE RX850 EIZO CORPORATION HIROAKI HASHIMOTO
K140527 03/04/2014 SENSILIGHT MINI EL GLOBAL TRADE LTD. SHLOMIT SEGMAN
K140670 03/18/2014 ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ ELLIPSE A/S OLE KOFOD
K140613 03/10/2014 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES INC. John McIntyre
K140675 03/18/2014 EMERGE EXTERNAL FIXATION SYSTEM EMERGE MEDICAL, INC. MICHELLE POTVIN
K140760 03/27/2014 BONASTENT BILIARY ENDOCHOICE, INC. BOSMAT FRIEDMAN
K140677 03/18/2014 MYLABSSOGNO ESAOTE S.P.A. ALLISON SCOTT
K140560 03/05/2014 ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
DEN140002 03/28/2014 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US MICHAEL LOCKE
K140689 03/19/2014 IKNEE DISTAL FEMORAL CUTTING GUIDE EVERGREEN ORTHOPEDIC RESEARCH LAB JEFF STEPANIAN
K140645 03/14/2014 GIBRALT ROD-TO-ROD CROSS CONNECTORS EXACTECH SARASOTA PATRICK HUGHES
K140674 03/18/2014 EXACTECH TAPERED WEDGE FEMORAL STEM EXACTECH, INC. SHING JEN TAI, PHD
K140568 03/05/2014 CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT FACET TECHNOLOGIES, LLC JENNIFER REGISTER
K140242 03/06/2014 FEIYUE FEIYUE GLOVE CO., LTD. CHU XIAOAN
K140601 03/10/2014 FLOW-NAIL FLOW-FX, LLC MICHELLE MCDONOUGH
K140584 03/07/2014 ICEROD CX CRYOABLATION NEEDLE GALIL MEDICAL LTD. LYNNE DAVIES
K140693 03/20/2014 VSCAN WITH DUAL PROBE GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC TRACEY ORTIZ
K140583 03/17/2014 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K140610 03/18/2014 NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) HARTALEGA NGC SDN. BHD. NURUL AISYAH KONG
K140546 03/04/2014 HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST HEALGEN SCIENTIFIC, LLC JOE SHIA
K140639 03/12/2014 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM HITACHI ALOKA MEDICAL, LTD. ANGELA VANARSDALE
K140443 03/04/2014 ARIETTA 60/ARIETTAS60/ARIETTAV60 HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL AMERICA) ANGELA VANARSDALE
K140650 03/13/2014 HIVOX ELECTRIC STIMULATOR OTC TENS HIVOX BIOTEK, INC. KE-MIN JEN
K140707 03/24/2014 LIFEBORNE INFANT RESUSCITATOR INTERNATIONAL BIOMEDICAL AMY PIEPER
K140716 03/21/2014 OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE INTERVENTIONAL SPINE, INC. JANE METCALF
K140751 03/25/2014 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD JINYOUNG LEE
K140553 03/04/2014 ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS INTUITIVE SURGICAL, INC. DAWN CHANG
K140239 03/18/2014 JIAWANG JIAWANG GLOVE CO., LTD. CHU XIAOAN
K140765 03/27/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K140529 03/04/2014 EVEREST SPINAL SYSTEM K2M, LLC NANCY GIEZEN
K140678 03/18/2014 COSMOLOCK PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC J.D. WEBB
K140539 03/04/2014 AERO BLUE PERFORMANCE SURGICAL GOWN KIMBERLY-CLARK CORPORATION DAVID M LEE
K140562 03/05/2014 WIJAY EZ-VOID EXTERNAL CATHETER VALVE LEOMED, LLC BANDULA WIJAY
K140768 03/27/2014 TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. ARTHUR GODDARD
K140647 03/13/2014 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) LUMINEX MOLECULAR DIAGNOSTICS, INC. Tina Ip
K140569 03/06/2014 ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) MAQUET CARDIOPULMONARY AG SARAH BETZ
K140755 03/26/2014 ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS MEDICAL COMPRESSION SYSTEMS (DBN) LTD. ADELY LEVY
K140738 03/25/2014 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K140730 03/24/2014 VIAL2BAG DIRECT CONNECT MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K140753 03/26/2014 ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM MEDIVATORS KINNARI SHAH
K140750 03/25/2014 SHILLA GROWTH GUIDANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K140564 03/10/2014 BN LUMBAR CAGE SYSTEM MEDYSSEY USA, INC. RICH JANSEN, PHARM D.
K140642 03/12/2014 PCD 737A MEGO AFEK AC LTD AHARON COHEN
K140626 03/11/2014 MELUNA CLASSIC/SPORT MENSTRUAL CUP MELUNA YOLANDA SMITH
K140608 03/10/2014 MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC. SIOBHAN KING
K140543 03/04/2014 PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K140758 03/26/2014 M-PM-DISC (PINK) MERZ DENTAL GMBH RICHARD G HUNTER
K140572 03/06/2014 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND SUSAN D GOLDSTEIN-FALK
K140735 03/24/2014 EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS MICROPORT ORTHOPEDICS INC. CAROLINE FRYAR
K140676 03/18/2014 PROFEMUR TL CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K140557 03/05/2014 MIVI 6F GUIDE CATHETER MIVI, LLC MICHELLE STRAIGHT
K140660 03/14/2014 MOBIUS3D MOBIUS MEDICAL SYSTEMS, LP STAN ESHELMAN
K140530 03/04/2014 Electro Auricular Device NAVIGANT CONSULTING, INC. COLLEEN HITTLE
K140586 03/07/2014 ASCEND ELECTRODE NEUROMETRIX, INC. RAINER MAAS
K140724 03/21/2014 MSP METATARSAL SHORTENING SYSTEM NEXTREMITY SOLUTIONS, INC. JORGE A MONTOYA
K140785 03/31/2014 PULSE OXIMETER NONIN MEDICAL, INC. BRODIE PEDERSEN
K140701 03/24/2014 NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG NOVOSOURCE INC ALLISON SCOTT, RAC
K140803 03/31/2014 LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM NUCLETRON B.V. RUDOLF VOS
K140659 03/14/2014 COROENT THORACOLUMBAR IMPLANTS NUVASIVE, INCORPORATED OLGA LEWIS
K140563 03/05/2014 LATERAL VBR SYSTEM NUVASIVE, INCORPORATED JEREMY MARKOVICH
K140770 03/27/2014 MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K140623 03/11/2014 NXSTAGE EXPRESS FLUID WARMER NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K140571 03/06/2014 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. MARY L STROUMBOS
K140526 03/05/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K140709 03/21/2014 SKYHAWK INTERBODY FUSION SYSTEM ORTHOFIX INC. TROY BROOKS
K140550 03/04/2014 ORTHOHUB EXTERNAL FIXATOR SOFTWARE ORTHOHUB, INC. PEGGY MCLAUGHLIN
K140600 03/10/2014 SB ANCHOR OSSTEM IMPLANT CO., LTD. PATRICK LIM
K140644 03/13/2014 PROCEM OTOTRONIX, LLC BERNARD HORWATH
K140711 03/21/2014 COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, PARAGON BIOTECK, INC. LAUREN M-C BLUETT
K140551 03/04/2014 PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR PERKINELMER, INC. DAWN SPOONER
K140771 03/27/2014 PHILIPS ELEVA WORKSPOT PHILIPS MEDICAL SYSTEMS DMC GMBH GEROLD SCHWARZ
K140666 03/20/2014 MR ELASTOGRAPHY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SUSAN QUICK
K140535 03/04/2014 PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH MICHAEL ASMALSKY
K140696 03/20/2014 STREAMLINE TL SPINAL FIXATION SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K140713 03/21/2014 PLANMECA ROMEXIS PLANMECA OY LARS MORING
DEN140005 03/25/2014 LYRA DIRECT STREP ASSAY QUIDEL CORPORATION Ronald H Lollar
K140522 03/04/2014 RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K140646 03/13/2014 DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G RAYENCE CO., LTD DAVE KIM
K140638 03/18/2014 PROPELLER SYSTEM - MODEL 2 RECIPROCAL LABS CORPORATION J. DAVID SICKLE
K140780 03/28/2014 KEGEL SMART, KEGELSMART PEARL REGULATORY INSIGHT, INC. Kevin Walls
K140742 03/27/2014 RELIANCE ANTERIOR CERVICAL PLATE RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K140606 03/10/2014 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL RESONANCE INNOVATIONS LLC RANDALL JONES
K140542 03/04/2014 NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER RHINOSYSTEMS, INC. MARTIN R HOKE
K133193 03/07/2014 RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. SURESH KUMAR
K140534 03/04/2014 ELECSYS PRECICONTROL TS ROCHE DIAGNOSTICS JANE PHILLIPS
K140802 03/31/2014 STERISPINE PS SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K140576 03/06/2014 Y WIRE 2 SAFEWIRE, LLC STEPHEN W INGLESE
K140603 03/10/2014 ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM SAPHENA MEDICAL, INC. CHERYL BLAKE
K140559 03/10/2014 SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER SECHRIST INDUSTRIES, INC. VICTOR C ARELLANO
K140631 03/12/2014 LUMENA FH HAIR REMOVAL SYSTEM SHASER, INC. ANTHONY BURNS
K140681 03/18/2014 BELTER INFRA-RED EAR THERMOMETER SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE PANG MING
K140582 03/06/2014 FINGERTIP PULSE OXIMETER SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FIELD FU
K140690 03/19/2014 BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K140243 03/07/2014 SHUNTONG SHUNTONG GLOVE CO., LTD. CHU XIAOAN
K140717 03/20/2014 CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT SIEMENS HEALTHCARE DIAGNOSTICS Susan Tibedo
K140541 03/04/2014 IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C SIEMENS HEALTHCARE DIAGNOSTICS INC. GARO MIMARYAN
K140787 03/31/2014 PLS (POSTERIOR LUMBAR SYSTEM) SINTEA PLUSTEK, LLC RICH JANSEN
K140777 03/28/2014 ZQUIET-SA SLEEPING WELL, LLC WILLIAM MCLAIN
K140555 03/04/2014 JOURNEY II BCS CONSTRAINED INSERTS SMITH & NEPHEW, INC. SHEREEN BIENZ
K140775 03/28/2014 TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM SPECTRANETICS CORPORATION AMANDA JOHNSON
K140691 03/19/2014 IG_PLEX CELIAC DGP PANEL SQI DIAGNOSTICS SYSTEMS INC. Kate Smith
K140804 03/31/2014 VDRIVE WITH V-LOOP/ VDRIVE DUO STEREOTAXIS, INC. DIANE HORWITZ, PH.D., RAC
K140708 03/21/2014 VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR STERIS CORPORATION BILL BRODECK
K140737 03/24/2014 STRAUMANN CARES SCREW RETAINED BARS/BRIDGE STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K140588 03/07/2014 FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS STRYKER CORPORATION JULIA HELGESON
K140565 03/05/2014 VARIAX 2 COMPRESSION PLATING SYSTEM STRYKER TRAUMA AG ESTELA CELI
K140769 03/27/2014 VARIAX 2 SYSTEM STRYKER TRAUMA AG ELIJAH N WREH
K140685 03/18/2014 ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM SYBRONENDO COURTNEY CLARK
K140615 03/10/2014 VICTUS FEMTOSECOND LASER PLATFORM TECHNOLAS PERFECT VISION GMBH BETTY M JOHNSON
K140556 03/05/2014 CONCHASMART BREATHING CIRCUIT TELEFLEX, INC. Amanda Webb
K140533 03/04/2014 GALAFLEX MESH TEPHA, INC. MARY P LEGRAW
K140524 03/04/2014 TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM TERATECH CORP. BEN CHIAMPA
K140773 03/28/2014 TERASON USMART3300 ULTRASOUND SYSTEM TERATECH CORP. STEVEN R BROADSTONE
K140774 03/28/2014 TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORPORATION EILEEN DORSEY
K140686 03/19/2014 HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS THE BINDING SITE GROUP LTD SUZANNE HORNE
K140664 03/18/2014 HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS THE BINDING SITE GROUP, LTD. JON LAUDER
K140729 03/24/2014 APLIO ARTIDA, V3.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K140651 03/13/2014 CELESTEION, PCA-9000A/2 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K140648 03/13/2014 ST AIA-PACK C-PEPTIDE II CALIBRATOR SET TOSOH BIOSCIENCE, INC. ROBERT L WICK
K140763 03/27/2014 MONOFILAMENT POLYPECTOMY SNARE UNITED STATES ENDOSCOPY SAGAR D PIMPALWAR
K140528 03/04/2014 TRUE BEAM, TRUE BEAM STX, EDGE VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K140504 03/05/2014 ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM VASCULAR PATHWAYS, INC. BILL BOLD
K140629 03/11/2014 VENUS SWAN(MP)2 VENUS CONCEPT LTD. YORAM LEVY
K140531 03/04/2014 BIOFOAM BONE WEDGE WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K140749 03/28/2014 INFINITY TOTAL ANKLE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
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