FDA 510(k) Applications Received During June, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K141570 06/12/2014 IMPLANT STUDIO 3SHAPE MEDICAL A/S HANNE NIELSEN
K141659 06/20/2014 PRISM ZIRCONIA, ST-98 A & D DENTAL INNOVATIONS YOONHO JUN
K141678 06/23/2014 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular JESSICA KAO
K141693 06/24/2014 Tyvek« Pouch/Roll with STERRAD« Chemical Indicator ADVANCED STERILIZATION PRODUCTS SUN CHOI
K141622 06/17/2014 ILLUMINATED MEDIASTINOSCOPE AEGIS SURGICAL LTD TAMMY CARREA
K141694 06/24/2014 AESCULAP ORTHOPILOT NEXT GENERATION AESCULAP IMPLANT SYSTEMS, LLC JULIE TOM WING
K141687 06/12/2014 AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K141602 06/16/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K141609 06/16/2014 PULSTAR LOGIX PUMP ALBAHEALTH LLC SHANE BRUCE
K141476 06/04/2014 WAVELIGHT FS200 LASER SYSTEM ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. Bob Lundberg
K141757 06/30/2014 ALERE I STREP A ALERE SCARBOROUGH, INC Angela Drysdale
K141520 06/09/2014 ALERE I INFLUENZA A & B ALERE SCARBOROUGH, INC D/B/A BINAX, INC. Angela Drysdale
K141529 06/09/2014 ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S LORI E ADELS
K141450 06/02/2014 AXIOM 2.8 ANTHOGYR SAS THERESE CANDAU
K141522 06/09/2014 APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES APEX MEDICAL CORP. ALAN CHANG
K141567 06/12/2014 IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM APIRA SCIENCE, INC. RAYMOND R BLANCHE
K141559 06/12/2014 V-GUIDE FOR VENTRICULOSTOMIES ARC SURGICAL LLC. CRAIG PAGAN
K141742 06/27/2014 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS ARDO MEDICAL AG YARMELA PAVLOVIC
K141573 06/12/2014 SILVERLON ISLAND WOUND DRESSING ARGENTUM MEDICAL RICH FOSTER
K141618 06/17/2014 ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I ELIZABETH DUNCAN
K141735 06/27/2014 ARTHREX ANKLE FUSION PLATING SYSTEM ARTHREX, INC. LAURA MEDLIN
K141478 06/04/2014 ARTHREX FRACTURE PLATES AND SCREWS ARTHREX, INC. DAVID L ROGERS
K141635 06/19/2014 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. LEON BROWN II
K141577 06/13/2014 ARTHREX PIP DART ARTHREX, INC. DAVID L ROGERS
K141695 06/24/2014 ACROSSPINE PEDICLE SCREW SYSTEM ARTHRO-DIF RICH JANSEN
K141751 06/30/2014 ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR ASAHI INTECC CO., LTD. SEMIH OKTAY
K141680 06/23/2014 AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws AUXEIN MEDICAL RAHUL LUTHRA
K141663 06/23/2014 EEVA DISH (WITH 12 MICROWELLS) AUXOGYN, INC. JULIA S ANASTAS
K141556 06/12/2014 AVREO INTERWORKS SYSTEM AVREO, INC. ALISON MCKEE
K141536 06/10/2014 VIEWING CLIENT MOBILE AXON MEDICAL TECHNOLOGIES CORP. CHAS YU
K141468 06/03/2014 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) BD Biosciences Terrance Thiel
K141474 06/03/2014 BECTON DICKINSON INTELLIPORT SYSTEM BECTON DICKINSON & CO. DANIEL OLIVIER
K141725 06/26/2014 BONGOLD BONE GRAFT MATERIAL BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L HELEN CUI
K141672 06/23/2014 DIGIARC 100AU+ BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. JUNE LI
K141654 06/20/2014 THE BELMONT RAPID INFUSER BELMONT INSTRUMENT CORPORATION URAIWAN P LABADINI
K141581 06/13/2014 ASTROGLIDE NATURAL BIOFILM, INC. Sherry Castello
K141653 06/20/2014 BIOLOX DELTA CERAMIC OPTION HEADS BIOMET, INC. BECKY EARL
K141748 06/30/2014 RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K141483 06/05/2014 BIOSPACE BODY COMPOSITION ANALYZER BIOSPACE CORPORATION LIMITED DANIEL KAMM
K141637 06/19/2014 SPB SKIN EMULSION BIOTD, S.A. RICHARD GILLIS, PH.D.
K141439 06/02/2014 ORTHODONTIC ACRYLIC (NOT FINALIZED) BISCO, INC. Michelle Schiltz-Taing
K141597 06/13/2014 MUSTANG BALLOON DIALATION CATHETER Boston Scientific Corporation MELANIE RASKA
K141521 06/09/2014 MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER Boston Scientific Corporation MELANIE RASKA
K141584 06/13/2014 ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation THOMAS HIRTE
K141531 06/09/2014 POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER C.R. BARD, INC. BRYAN U STONE
K141465 06/03/2014 CARDIOGARD EMBOLI PROTECTION CANNULA CARDIOGARD MEDICAL LTD SHEILA H HEYER
K141552 06/11/2014 ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS CAREFUSION JOY GREIDANUS
K141722 06/25/2014 CAREFUSION GOLD TISSUE MARKER CAREFUSION JOY GREIDANUS
K141488 06/05/2014 CAREVIEW 1800R CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. JAMIE KU
K141652 06/20/2014 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER GEOFF POLLARD
K141480 06/04/2014 CVI42 CIRCLE CARDIOVASCULAR IMAGING INC SHIRANTHA SAMARAPPULI
K141606 06/16/2014 SURGICAL GOWN COBES INDUSTRIES CO., LTD. LYNN FU
K141721 06/25/2014 BOVINE PERICARDIUM PATCH COLLAFIRM LLC Surendra P Batra
K141608 06/16/2014 COLLAGEN DURA MEMBRANE COLLAGEN MATRIX, INC. PEGGY HANSEN
K141685 06/23/2014 CROC COMBAT MEDICAL SYSTEMS, LLC Calley Herzog
K141718 06/25/2014 INTERNAL HYDRATING GEL COMBE INCORPORATED PUSHPA RAO
K141737 06/27/2014 CONVENTUS PHS SYSTEM CONVENTUS ORTHOPAEDICS, INC. KENT LIND
K141523 06/09/2014 ALLY UPS COOPER SURGICAL, INC. TIM M LOHNES
K141479 06/04/2014 KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS COVIDIEN TEGHPAL SINGH
K141518 06/09/2014 Nellcor Bedside Respiratory Patient Monitoring System COVIDIEN JAMIE THOMAS
K141542 06/10/2014 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) Covidien LLC MIA M WARE
K141511 06/09/2014 SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS CYNOSURE, INC. HUDA YUSUF
K141747 06/30/2014 RHINOGUARD DAVIS MEDICAL MICHELLE LOTT
K141631 06/18/2014 AQUARIUS EXTENSION FEEDING SET DEGANIA SILICONE, LTD. ZOYA LEE
K141753 06/30/2014 AQUARIUS NASAL FEEDING TUBE DEGANIA SILICONE, LTD. ZOYA LEE
K141503 06/06/2014 DENALI 501CEMENT DENALI CORPORATION JAN G STANNARD
K141457 06/02/2014 DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS DENTIUM CO. LTD. SHERYL HIGGINS
K141578 06/13/2014 DEVON CIRONA 6200 DVT DEVON MEDICAL RUTH WU
K141575 06/12/2014 PLAC TEST FOR LP-PLA2 ACTIVITY DIADEXUS, INC. Lorry Weaver Huffman
K141463 06/03/2014 LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS DiaSorin Inc. CAROL A DEPOUW
K141586 06/13/2014 OWL CANNULAE DIROS TECHNOLOGY, INC. GEORGE DARMOS
K141484 06/05/2014 OPEN FMSEALER DOMAIN SURGICAL, INC. CURTIS JENSEN
K141565 06/12/2014 GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. GALE WINARSKY
K141756 06/30/2014 INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc. KAREN PROVENCHER
K141623 06/17/2014 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM ECO MEDI GLOVE SDN BHD SURESH KUMAR
K141579 06/13/2014 EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141590 06/13/2014 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141510 06/09/2014 EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141745 06/30/2014 IQQA-BODYIMAGING SOFTWARE EDDA TECHNOLOGY DANIEL KAMM
K141696 06/24/2014 EDWARDS ESHEATH INTRODUCER SET EDWARDS LIFESCIENCES NEIL DELANEY
K141495 06/06/2014 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER EDWARDS LIFESCIENCES, LLC. ANDREW S MAZURKIEWICZ, JR
K141739 06/27/2014 RESIDUAL LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. REBECCA SHELBURNE
K141447 06/02/2014 PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. REBECCA SHELBURNE
K141598 06/13/2014 FUSE COLONOSCOPY SYSTEM ENDOCHOICE, INC. TAMAR FUERST
K141615 06/16/2014 ENDOPHYS BLOOD PRESSURE MONITOR ENDOPHYS, INC. RONALD S WARREN
K141486 06/05/2014 MYLABSIX ULTRASOUND SYSTEM ESAOTE EUROPE B.V. Allison Scott
K141560 06/12/2014 ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, INC. SUSAN LIN
K141492 06/05/2014 ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) EUROSETS S.R.L. MARIO GENNARI
K141749 06/30/2014 CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT FACET TECHNOLOGIES, LLC JENNIFER REGISTER
K141666 06/23/2014 FERTILIGENT SLOW RELEASE IUI CATHETER KIT FERTILIGENT, LTD BABACAR DIOUF
K141456 06/02/2014 THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL FIAGON GMBH DIRK MUCHA
K141460 06/02/2014 FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR FINAPRES MEDICAL SYSTEMS BV IR. PAUL KOSTERS
K141458 06/02/2014 SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK FOCUS DIAGNOSTICS SHARON YOUNG
K141691 06/24/2014 GEN_3 FREE WHEELCHAIR MISSION SHARON ROCKWELL
K141514 06/09/2014 SYNAPSE 3D TENSOR ANALYSIS FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. JYH-SHYAN LIN
K141485 06/05/2014 ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE GALIL MEDICAL LTD. LYNN DAVIES
K141557 06/12/2014 HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR GALLINI MEDICAL DEVICES, SRL ARTHUR S GODDARD
K141562 06/12/2014 MSN-006 GC AMERICA, INC. MARK HEISS
K141675 06/25/2014 VOLUSON P6, VOLUSON P8 GE HEALTHCARE BRYAN BEHN
K141639 06/19/2014 VOLUSON S6, VOLUSON S8 GE HEALTHCARE BRYAN BEHN
K141477 06/04/2014 DISCOVERY IQ GE MEDICAL SYSTEMS, LLC HUY DOAN
K141700 06/24/2014 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. KAITLYNN MIN
K141532 06/10/2014 CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K141712 06/25/2014 KIMGUARD ONE STEP STERILIZATION WRAP Halyard Health Thomas Kozma
K141614 06/16/2014 MAGELLAN ROBOTIC SYSTEM Hansen Medical KATE W LEE
K141647 06/19/2014 HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) HEALGEN SCIENTIFIC, LLC Joe Shia
K141642 06/19/2014 VAPRO INTERMITTENT CATHETER HOLLISTER, INCORPORATED JEANNE LEE
K141619 06/17/2014 LUOFUCON SILVER FOAM DRESSING HUIZHOU FORYOU MEDICAL DEVICES CO, LTD CHARLES SHEN
K141451 06/02/2014 VixWin Platinum IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC) SANJAY AHUJA
K141572 06/12/2014 MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K141750 06/30/2014 HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
K141682 06/23/2014 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. STEVEN J CHARTIER
K141443 06/02/2014 INFRONT LUMBAR INTERBODY FUSION SYSTEM INFRONT MEDICAL, LLC JOHN KUCZYNSKI
K141713 06/25/2014 SMARTGRAFT 200 SYSTEM INGENERON, INC. ANITA KADALA
K141591 06/13/2014 SMARTGRAFT 30 SYSTEM INGENERON, INC. ANITA KADALA
K141644 06/19/2014 INNOVASIS CRANIAL SYSTEM INNOVASIS, INC. MARSHALL MCCARTY
K141655 06/20/2014 QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS INOVA DIAGNOSTICS, INC. GRABRIELLA LAKOS
K141668 06/23/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION JANET C KAY
K141674 06/23/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION TIMOTHY CONNORS
K141643 06/19/2014 YARLAP INTERNATIONAL TRADE GROUP, INC. BRENT C REIDER
K141701 06/24/2014 I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] ISOAID, L.L.C. MARY ANN GREENAWALT
K141452 06/02/2014 LEFORTE NEURO SYSTEM BONE PLATE AND SCREW JEIL MEDICAL CORPORATION Priscilla Chung
K141670 06/23/2014 ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA JOHNSON & JOHNSON VISION CARE, INC. SCOTT DURLAND
K141505 06/06/2014 BASAL DIGITAL THERMOMETER K-JUMP HEALTH CO., LTD. JM LIN
K141576 06/12/2014 Maxima PRO 45L KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA MARCOS FERNANDES NUNES
K141738 06/27/2014 MEDEOR MATRIX WOUND DRESSING KENSEY NASH CORPORATION DBA DSM BIOMEDICAL BRIANNA JORDAN
K141612 06/16/2014 KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE MARCIA JOHNSON
K141489 06/05/2014 LINOS MOH HAND PLATING SYSTEM KLS MARTIN L.P. JENNIFER DAMATO
DEN140001 06/16/2014 ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. TANIS JIMENEZ
K141539 06/10/2014 KUBTEC X250 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K141707 06/24/2014 ULTRASKIN HYDROPHILIC GUIDE WIRE LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. ARTHUR GODDARD
K141727 06/26/2014 DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) LIAONING UPCERA CO.,LTD CHARLES SHEN
K141723 06/26/2014 UPCERA COLORING LIQUID (I AND II ) LIAONING UPCERA CO.,LTD CHARLES SHEN
K141724 06/26/2014 UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK LIAONING UPCERA CO.,LTD CHARLES SHEN
K141658 06/20/2014 LIGHT SCALPEL LIGHT SCALPEL LLC DAVID WALTERS
K141453 06/02/2014 ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K141555 06/12/2014 ADVANTAGE LUTRONIC CORPORATION JHUNG W VOJIR
K141553 06/11/2014 MEDELA THOPAZ+ MEDELA AG ORLANDO ANTUNES
K141506 06/06/2014 MCC Para-Fix CARY BLAIR MEDIUM MEDICAL CHEMICAL CORPORATION KRIS J KONTIS
K141633 06/18/2014 PRO-PICC WITH VALVE TECHNOLOGY MEDICAL COMPONENTS INC JONATHAN SCHELL
K141509 06/06/2014 ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS MEDOS SARL KIRSTEN LEHMULLER
K141704 06/24/2014 NOVASHIELD INJECTABLE NASAL PACKING AND STENT MEDTRONIC INC. RISHI SINHA
K141494 06/06/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. ERIKKA EDWARDSEN
K141604 06/16/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K141605 06/16/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MICHAEL SCOTT
K141599 06/13/2014 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SHWETA SHARMA
K141632 06/18/2014 ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. KRISTI FRISCH
K141587 06/13/2014 E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER MEGADYNE MEDICAL PRODUCTS, INC. RONDA MAGNESON
K141441 06/02/2014 MENNTOR X7 MENNEN MEDICAL LTD. IFAT SHWARTS
K141493 06/05/2014 PROXIMAL HUMERUS PLATING SYSTEM Miami Device Solutions PETER J MINCIELI
K141516 06/09/2014 MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
K141491 06/05/2014 SOLITAIRE 2 REVASCULARIZATION DEVICE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR LARRY BOUCHER
K141455 06/02/2014 EASYDRILL AUTOSTOP CRANIAL PERFORATOR MICROMAR IND. COM. LTD. DEEP PAL
K141603 06/16/2014 Ultra Silver Dressings MILLIKEN HEALTHCARE PRODUCTS, LLC GORDON MACFARLANE
K141719 06/25/2014 BIOGEL PL MICRO SURGICAL GLOVE MOLNLYCKE HEALTH CARE, US LLC CURTIS TRUESDALE
K141684 06/23/2014 JUSHA-C33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141679 06/23/2014 JUSHA-C61 LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141690 06/23/2014 JUSHA-M33C LCD MONITOR NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD LI LE
K141515 06/09/2014 AED HYSTEROSCOPE AND ACCESSORIES NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE BUTLER
K141446 06/02/2014 ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, NATUS MEDICAL INCORPORATED JUDY BUCKHAM
K141660 06/20/2014 NAWALUTION SKIN AND WOUND CLEANSER NAWA HEILMITTEL GMBH ALLYSON B MULLEN
K141715 06/25/2014 GLOVE PORT NELIS PETER CHUNG
K141669 06/23/2014 SURGIMAP NEMARIS INC KEITH BARRITT
K141731 06/27/2014 NEPHROS DSU-H, NEPHROS SSU-H NEPHROS, INC. JAMES SUMMERTON
K141462 06/03/2014 VARIA-NCI NEUROCHAOS SOLUTIONS, INC. ELISA MALDONADO-HOLMERTZ
K141548 06/11/2014 HIGH TIBIAL OSTEOTOMY SYSTEM NEWCLIP TECHNICS J.D. WEBB
K141588 06/13/2014 NUTRA STIM HAIR LASER COMB NUTRA LUXE MD, LLC JILL CREASY
K141596 06/13/2014 NUTRA STIM HAIR LASER COMB NUTRA LUXE MD, LLC JILL CREASY
K141665 06/23/2014 NuVasive CoRoent System NUVASIVE, INC. JEREMY MARKOVICH
K141752 06/30/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K141595 06/13/2014 O-TWO E700,O-TWO E600,O-TWO E500 O-TWO MEDICAL TECHNOLOGIES, INC. David Zhang
K141440 06/02/2014 DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH DANIEL KAMM, P.E.
K141611 06/16/2014 LYTHOS DIGITAL IMPRESSION SYSTEM ORMCO CORP. COURTNEY CLARK
K141502 06/06/2014 HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. Howard Schrayer
K141571 06/12/2014 ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM ORTHOFIX SRL TROY BROOKS
K141497 06/06/2014 PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) OSSTEM IMPLANT CO.,LTD PATRICK LIM
K141550 06/11/2014 INSTAFIX SHAPE MEMORY FIXATION SYSTEM OT MEDICAL WILLIAM RHODA
K141616 06/16/2014 STERILIZATION CASSETTE OTICON MEDICAL AB CAROL A WESSLING
K141717 06/25/2014 PACSEAL PIT & FISSURE SEALANT PAC-DENT INTERNATIONAL, INC. WENYING ZHU
DEN140020 06/24/2014 ECLIPSE SYSTEM PELVALON CINDY DOMECUS
K141736 06/27/2014 PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST PHILIPS MEDICAL SYSTEMS DMC GMBH GEROLD SCHWARZ
K141656 06/20/2014 GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM Philosys Inc. LINDA CHAN
K141600 06/16/2014 NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I SARAH MCINTYRE
K141711 06/25/2014 PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE PONTIS ORTHOPAEEICS, LLC LEONARD GORDON
K141638 06/19/2014 PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE PROPPER MANUFACTURING CO.,INC. ANDREW SHARAVARA
K141689 06/23/2014 FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit Qualigen, Inc. Michael Poirier
K141743 06/30/2014 FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT RADIOLOGY SOLUTIONS LLC DANIEL KAMM, P.E.
K141566 06/12/2014 SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC RAYENCE CO., LTD DAVE KIM
K141563 06/12/2014 SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC RAYENCE CO., LTD DAVE KIM
K141496 06/06/2014 MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER REFLECTANCE MEDICAL, INC. Nandini Murthy
K141649 06/20/2014 SPEX SUPPORT CATHETER REFLOW MEDICAL Rebecca K Pine
K141547 06/11/2014 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL Rebecca K Pine
K141676 06/23/2014 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton, Ph.D.
K141617 06/17/2014 CLEANERXT ROTATIONAL THROMBECTOMY SYSTEM, CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL, L.P. SUSAN D GOLDSTEIN-FALK
K141664 06/23/2014 SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION REXAM HEALTHCARE BEATRICE GRAND DEMARS
K141634 06/18/2014 NAUTILUS DELTA ROMEDEX INTERNATIONAL SRL SORIN GRUNWALD
K141482 06/04/2014 KI-20 SAEYANG MICROTECH CO LTD Priscilla Chung
K141620 06/17/2014 RS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K141755 06/30/2014 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K141728 06/26/2014 ACE CALIBRATOR SENTINEL CH. SpA Patricia Dupe
K141640 06/19/2014 AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. CHARMAINE HENDERSON
K141583 06/13/2014 SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY SHASER, INC. ANTHONY BURNS
K141683 06/23/2014 ELECTRONIC BLOOD PRESSURE MONITOR SHENZHEN URION TECHNOLOGY CO., LTD. AUTUMN LIU
K141444 06/02/2014 IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL Siemens Healthcare Diagnostics Inc. DONNA VELASQUEZ
K141574 06/12/2014 ARTIS ZEE/ZEEGO SW VC21 SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K141554 06/11/2014 ESIE APPS SUITE SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K141473 06/03/2014 SMC ACUPUNCTURE NEEDLE SMC INTL., INC. JONG-MAN LEE
K141471 06/03/2014 JOURNEY II XR KNEE SYSTEM SMITH & NEPHEW, INC. Shereen Bienz
K141585 06/13/2014 SMITH & NEPHEW DISPOSABLE FIN PUNCH SMITH & NEPHEW, INC. JENNY WALDRIP
K141686 06/23/2014 EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY SMITH MEDICAL ASD, INC. JIM JOHNSON
K141454 06/02/2014 SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD SONY ELECTRONICS, INC. JOANNE BRONIKOWSKI
K141508 06/06/2014 ROMEO 2 PAD POSTERIOR AXIAL DEVICE SPINEART FRANCK PENNESI
K141537 06/10/2014 IN:C2 SPINAL FIXATION SYSTME SPINESMITH HOLDINGS, LLC CLIFTON (CHRIS) NAIVAR
K141530 06/09/2014 VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS STEREOTAXIS, INC. DIANA HORWITZ, PH.D., RAC
K141551 06/11/2014 PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) STRYKER CORPORATE BECKY DITTY
K141673 06/23/2014 IVAS 8 GAUGE BONE BIOPSY KIT STRYKER CORPORATION BRITTNEY L LARSEN
K141677 06/23/2014 VARIAX ELBOW PLATING SYSTEM Stryker Trauma AG ELIJAH N WREH
K141513 06/09/2014 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM SUMMIT MEDICAL, INC. NICOLE DOVE
K141625 06/17/2014 POLYSYN SURGICAL SUTURE SURGICAL SPECIALTIES CORP. PAUL AMUDALA
K141558 06/12/2014 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE SURGICAL SPECIALTIES CORP. KIRSTEN STOWELL FRANCO
K141507 06/06/2014 TWO SKIN TREATMENT SYSTEM SYNERON MEDICAL LTD. JANICE M HOGAN
K141708 06/24/2014 ULTRASHAPE SYSTEM SYNERON MEDICAL LTD. JANICE M HOGAN
K141499 06/06/2014 X-REPAIRSL SYNTHASOME, INC. ANTHONY RATCLIFFE
K141527 06/09/2014 DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM SYNTHES USA ANGELA F LASSANDRO
K141681 06/23/2014 SYSMEX XN SERIES SYSMEX AMERICA, INC. SHARITA BROOKS
K141758 06/30/2014 T:SLIM INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. JANICE HOGAN
K141524 06/09/2014 NEURO-AUDIO TELEEMG, LLC USA BARRY ASHAR
K141448 06/02/2014 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM TEVA MEDICAL LTD., MIGADA PLANT ROGER L GRAY
K141657 06/20/2014 THD REVOLUTION THD SPA MAURIZIO PANTALEONI
K141475 06/04/2014 ENDOSIZE THERENVA SAS CEMIL GOKSU
K141651 06/20/2014 SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific Cynthia Knapp
K141504 06/06/2014 T-8000 THEROZONE UNIT THEROZONE USA, INC. Rebecca K Pine
K141481 06/04/2014 TRC-NW400 NON-MYDRIATIC RETINAL CAMERA TOPCON CORPORATION MAUREEN O'CONNELL
K141472 06/03/2014 VANTAGE ELAN TOSHIBA AMERICA MEDICAL SYSTEMS INC PAUL BIGGINS
K141459 06/02/2014 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATION ORLANDO TADEO
K141741 06/27/2014 AQUILION PRIME, V6.00 TOSHIBA MEDICAL SYSTEMS CORPORATION ORLANDO TADEO
K141541 06/10/2014 XIDF-AWS801, ANGIO WORKSTATION, V5.31 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K141607 06/16/2014 DENTAL IMAGING SOFTWARE TROPHY MARIE-PIERRE LABAT-CAMY
K141698 06/24/2014 STERIZONE CHEMICAL INDICATOR TSO3 INC. THOMAS RICHARDS, PH.D.
K141580 06/13/2014 STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR TSO3 INC. THOMAS RICHARDS
K141593 06/13/2014 UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. LONG YANG
K141592 06/13/2014 UNIMICRO SUCTION IRRIATION TUBING SET UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. LONG YANG
K141594 06/13/2014 Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. LONG YANG
K141720 06/25/2014 iuStar300 Medical Ultrasound Diagnostic System UNITED IMAGING SYSTEMS (BEIJING) CO., LTD. JUN PENG
K141624 06/17/2014 PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K141490 06/05/2014 UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K141699 06/24/2014 VASSEN COLOR VASSEN CO., LTD. BRET ANDRE
K141706 06/24/2014 ECARE COORDINATOR (ECC) VISICU, INC. CHRIS FERGUSON
K141561 06/12/2014 VM PACS WITH VM MEDICAL WORKSTATION VISUAL MEDICA MELISSA LLABRES GRAU
K141546 06/10/2014 VITALOGRAPH MODEL 7000 SPIROTRAC VITALOGRAPH(IRELAND) LTD. TOM J HEALY
K141610 06/16/2014 FUTURABOND M+ VOCO GMBH T. GERKENSMEIER
K141582 06/13/2014 CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION WELCH ALLYN KEVIN CROSSEN
K141464 06/03/2014 NOVAGUARD S A SAFETY SYSTEM WEST PHARMACEUTICAL SERVICES KEVIN LENTZ
K141746 06/30/2014 AS20 COMPOSITE GRAFT WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K141740 06/27/2014 INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K141714 06/25/2014 PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K141467 06/03/2014 SURGICAL GOWN XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L MIKE GU
K141613 06/16/2014 GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD CHU XIAOAN
K141601 06/16/2014 IASSIST KNEE SYSTEM ZIMMER CAS CHRISTOPHER MCLEAN
K141544 06/10/2014 ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM ZIMMER DENTAL INC. CHRISTINA BOYDSTON
K141564 06/12/2014 OPTON PRO ZIMMER MEDIZINSYSTEMS GMBH ARMIN PETRASCHKA
K141500 06/06/2014 OPTIO-C ANTERIOR CERVICAL SYSTEM ZIMMER SPINE, INC. DONNA M SEMLAK
K141697 06/24/2014 XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM ZIMMER, INC. ROMIL SHETH
K141734 06/27/2014 ZIMMER PERIARTICULAR LOCKING SYSTEM ZIMMER, INC. STEPHEN H MCKELVEY, MA,RAC
K141517 06/09/2014 ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES ZIMMER, INC. STEPHEN H MCKELVEY,MA, RAC
K141641 06/19/2014 ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM ZONARE MEDICAL SYSTEMS, INC. DAN BRADFORD
K141549 06/11/2014 SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. Diane Brinza


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