FDA 510(k) Applications Received During June, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K081549 06/03/2008 RX ACCUNET LP EMBOLIC PROTECTION SYSTEM ABBOTT LABORATORIES VIRGINIA SINGER
K081622 06/10/2008 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM ABBOTT SPINE, INC. MARITZA ELIAS
K081523 06/02/2008 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE TAYLOR
K081697 06/17/2008 THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K081588 06/05/2008 RE-ZORB PLATING SYSTEM ACUTE INNOVATIONS LLC ALYSSA THOMAS
K081751 06/19/2008 ADIN DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEM LTD BENNY ARAZY
K081545 06/02/2008 ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 ADVANCED MEDICAL OPTICS, INC. KIM REGIS
K081681 06/17/2008 VITRECTOMY CUTTER AND ACCESSORIES ADVANCED MEDICAL OPTICS, INC. Evelyn De La Vega
K081650 06/12/2008 AERONEB GO NEBULIZER AEROGEN (IRELAND) LTD FRANK ENRIGHT
K081612 06/09/2008 AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS AESCULIGHT, LLC PAUL DIAZ
K081843 06/30/2008 ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 ALOKA CO., LTD. RICHARD CEHOVSKY
K081730 06/18/2008 NOVEL CERVICAL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY SCANNERS
K081710 06/17/2008 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE AMERICAN MEDICAL SYSTEMS DENISE THOMPSON
K081613 06/09/2008 SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS AMERICAN MEDICAL SYSTEMS, INC. SARAH PETERSON
K081767 06/20/2008 AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 AMNISURE INTERNATIONAL, LLC MICHAEL FRIEDMAN
K081841 06/30/2008 AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER AMPLIVOX, LTD. DANIEL KAMM
K081853 06/30/2008 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K081724 06/18/2008 HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL APPLIED NUTRITIONALS ANITA PETITO
K081664 06/13/2008 NOMAD PRO X-RAY SYSTEM ARIBEX, INC. D. CLARK TURNER
K081541 06/02/2008 DERMABLATE EFFECT ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K081752 06/20/2008 EDGE PACS ASHVA TECHNOLOGIES, PVT. LTD CARL ALLETTO
K081666 06/13/2008 ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS ASTRA TECH, INC. BETSY A BROWN
K081551 06/03/2008 TWIN NEUROTRAC-III ASTRO-MED, INC. ALFREDO BUSTAMANTE
K081718 06/18/2008 EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. KAREN HALL
K081820 06/27/2008 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR AVALON LABORATORIES, LLC DAVID C FURR
K081742 06/19/2008 BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 BAXANO, INC. TRENA DEPEL
K081717 06/18/2008 TRICOS A RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORP. VALERIE FOLLOWELL
K081721 06/18/2008 TRICOS A RESORBABLE SUBSTITUTE BAXTER HEALTHCARE CORP. BARBARA K BARBEAU
K081822 06/27/2008 COULTER 6C CELL CONTROL, MODELS 628027 & A59925 BECKMAN COULTER, INC. LOURDES COBA
K081641 06/11/2008 COULTER LIN-X LINEARITY CONTROL BECKMAN COULTER, INC. NANCY NADLER
K081526 06/02/2008 FLOWCARE TLG REAGENT BECKMAN COULTER, INC. NANCY NADLER
K081824 06/27/2008 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K081825 06/27/2008 BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K081547 06/02/2008 BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC BIO-MED U.S.A., INC. YOUNG CHI
K081729 06/18/2008 MODIFICATION TO GFX NERVE ABLATION SYSTEM BIOFORM MEDICAL, INC. LORI HAYS
K081818 06/27/2008 BIOLOK MICRO-LOK IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K081835 06/27/2008 ACTICARE IC AND TSE BIOINDUCTION LIMITED KRISTA OAKES
K081589 06/05/2008 WATERLASE, VERSION 3.0 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K081636 06/11/2008 PEEK-OPTIMA ALIF SPACER BIOMET SPINE VIVIAN KELLY
K081787 06/24/2008 CAMLAB CRANIAL ORTHOSIS HELMET BIOSCULPTOR CORPORATION MARK MAZLOFF
K081656 06/12/2008 VISUALASE THERMAL THERAPY SYSTEM BIOTEX, INC. ROGER MCNICHOLS
K081684 06/17/2008 BLACKSTONE PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K081849 06/30/2008 BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K081550 06/03/2008 BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO BONART CO. LTD. ERIC L ONG
K081733 06/19/2008 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 BOSTON SCIENTIFIC CORP. WING NG
K081739 06/19/2008 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT BOSTON SCIENTIFIC CORP. Marybeth Gamber
K081576 06/05/2008 BLAZER DX-20 DIAGNOSTIC CATHETER BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K081777 06/23/2008 VENTRIO HERNIA PATCH C.R. BARD, INC. STEPHANIE BAKER
K081855 06/30/2008 IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) CANADA, INC. FEDERICO FORERO
K081648 06/12/2008 DIGITAL RADIOGRAPHY CXDI-60G CANON, INC. SHEILA DRISCOLL
K081837 06/30/2008 AVEA VENTILATOR CARDINAL HEALTH 207, INC. ANDRE VON MULLER
K081670 06/13/2008 THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK CARDINAL HEALTH 207, INC. ANDRE VON MULLER
K081836 06/30/2008 CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM CARESTREAM HEALTH,INC. CHRISTINE EHMANN
K081531 06/02/2008 AOC SOLUBLE IMPLANT MATERIAL CEREMED, INC. TADEUSZ WELLISZ
K081619 06/09/2008 CHROMOLITE EP CHROMOGENEX TECHNOLOGIES LIMITED PETER R BEVAN
K081677 06/17/2008 SAVI APPLICATOR KIT CIANNA MEDICAL, INC. GARY MOCNIK
K081602 06/06/2008 DIZZYFIX CLEARWATER CLINICAL LIMITED MATTHEW BROMWICH
K081606 06/06/2008 BAHA INTENSO COCHLEAR AMERICAS SEAN BUNDY
K081537 06/02/2008 CFS FLEXIBLE COMFORT AND FLEXIBLE SYSTEMS JAY MANSOUR
K081556 06/03/2008 CADSTREAM, VERSION 5.0 CONFIRMA, INC. BRENT LEWIS
K081644 06/12/2008 BEAMER ARGON PROBE CONMED CORPORATION KAREN PROVENCHER
K081580 06/05/2008 BEAMER ARGON SNARE PROBE CONMED CORPORATION KAREN PROVENCHER
K081634 06/11/2008 CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL CONMED CORPORATION SHAWN RIEDEL
K081768 06/20/2008 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES COOK INCORPORATED SUSANNE GALIN
K081690 06/17/2008 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER COOK, INC. NATHAN SIMON
K081564 06/04/2008 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION CREASPINE CYNTHIA J NOLTE
K081762 06/20/2008 CURBELL PATIENT MONITORING CABLES CURBELL ELECTRONICS INC. Kevin Walls
K081816 06/26/2008 VOCALIS AND VOCALIS SM CYTOPHIL INC Greg Johnson
K081815 06/26/2008 VOCALIS GEL CYTOPHIL INC Greg Johnson
K081829 06/27/2008 CAPIMAGE DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K081842 06/30/2008 ENGSTROM CARESTATION, ENGSTROM PRO DATEX-OHMEDA, INC. ADRIENNE LENZ
K081844 06/30/2008 GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. ADRIENNE LENZ
K081669 06/13/2008 IMPROVED COMFORT-FIT NIGHTGUARD DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K081620 06/09/2008 MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K081546 06/02/2008 SMALL BONE LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081758 06/20/2008 HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 DEPUY SPINE, INC. HANDE TUFAN
K081584 06/05/2008 DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. MARY MCNAMARA-CULLINANE
K081746 06/19/2008 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K081685 06/17/2008 LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DIASORIN, INC. CAROL A DEPOUW
K081687 06/17/2008 LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DIASORIN, INC. CAROL A DEPOUW
K081743 06/19/2008 CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS DRAEGER MEDICAL AG & CO. KG KARIN LUEBBERS
K081694 06/17/2008 DENJECTOR DXM CO., LTD. MARIA GRIFFIN
K081569 06/04/2008 DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS DYNAREX CORPORATION VIJAY SACHDEV
K081847 06/30/2008 PICASSO MASTER, ECT AND MASTER 3D E-WOO TECHNOLOGY DAVE KIM
K081652 06/12/2008 CLAROS NANO DENTAL LASER SYSTEM ELEXXION AG HOLGER ERNST
K081565 06/04/2008 INTEGRE PRO, MODEL L2RY Ellex Medical Pty. Ltd. KEVIN HOWARD
K081679 06/17/2008 REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K081542 06/02/2008 MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. Sew-Wah Tay
K081703 06/17/2008 MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS ENTRA HEALTH SYSTEMS, LTD. CARLOS GONZALEZ
K081796 06/25/2008 EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM EPS BIO TECHNOLOGY CORP. Y.C. LEI
K081794 06/25/2008 MODEL 7340 ULTRASOUND SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K081741 06/19/2008 NEUROLINK IP, MODEL PK1113 EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K081578 06/05/2008 ACCELA SYSTEM GENESIS BIOSYSTEMS, INC. STEPHEN J MACDONALD
K081640 06/11/2008 GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS GIMMI GMBH KEN BLAKE
K081838 06/30/2008 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING GISH BIOMEDICAL, INC. MARTIN SELLERS
K081821 06/27/2008 D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) GLOBAL PATHOGEN SOLUTIONS INC. CARSON LINKER
K081712 06/17/2008 FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 GUANGDONG BIOLIGHT MEDITECH CO., LTD. Diana Hong
K081766 06/20/2008 PKS OMNI INSTRUMENT GYRUS-ACMI L.P. LORRAINE CALZETTA
K081738 06/19/2008 ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 HEALTH & LIFE CO., LTD. SAMUEL PIPER
K081603 06/06/2008 DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 HEARTFORCE MEDICAL, INC. ARTHUR WARD
K081745 06/19/2008 ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K081572 06/04/2008 SMARTSIGNS MINPULSE HUNTLEIGH HEALTHCARE LTD. ROBERT MCCARTHY
K081806 06/26/2008 IDI IMPLANT SYSTEM IDI BIOMEDICAL LLC ANGELA BLACKWELL
K081630 06/11/2008 MAMMO WORKSTATION IMAGE DIAGNOST INTERNATIONAL GMBH PETER HEINLEIN
K081698 06/17/2008 MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) IMAGE STREAM MEDICAL, INC. CHAS BURR
K081653 06/12/2008 MDI MII ONE-PIECE IMPLANT, 2.9MM IMTEC CORP. GLENN GEE
K081788 06/24/2008 INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 INNOCHIPS TECHNOLOGY CO., LTD. BRANDON CHOI
K081782 06/23/2008 COLLIEVA INNOCOLL PHARMACEUTICALS AARON WYSE
K081740 06/19/2008 HEMOBAND, MODELS HB-NS AND HB-NSXL INNOVATIONS FOR ACCESS, INC. HAL J OIEN
K081691 06/17/2008 INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS LLC DAVID TRUEBLOOD
K081651 06/12/2008 INSTRUMED RONGEUR INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K081693 06/17/2008 NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K081778 06/23/2008 NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K081635 06/11/2008 INTEGRA MESHED BILAYER WOUND MATRIX INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K081773 06/23/2008 OSV II INTEGRA NEUROSCIENCES IMPLANTS S.A. JON CAPAROTTA
K081614 06/09/2008 ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES INTERBODY INNOVATIONS, LLP J.D. WEBB
K081579 06/05/2008 INVENTUS IMPLANT SYSTEM INVENTUS CO., LTD ROSHANA AHMED
K081673 06/13/2008 DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE IONICS MEDICAL CORP. M. LAINE MASHBUM
K081817 06/26/2008 ACCELL TBM-R ISOTIS ORTHOBIOLOGICS, INC JUDITH E O'GRADY
K081557 06/03/2008 PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER JDDB MANUFACTURING, INC JACQUIN C YOUNGBLOOD-JOHNSON
K081658 06/12/2008 POWDER-FREE VINYL EXAMINATION GLOVES JIANGSU ALFA GLOVE CO., LTD CHU XIAOAN
K081655 06/12/2008 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K081657 06/12/2008 POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K081755 06/20/2008 FUSION MEDICAL STI JOHN RICCIO JOHN RICCIO
K081695 06/17/2008 DMC COMPOSITE KERR CORP. Wendy Garman
K081598 06/06/2008 SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE KFX MEDICAL GAYLE HIROTA
K081678 06/17/2008 CONMED BEAMER SYSTEM C600 KLS MARTIN GMBH + CO. KG BERNHARD HUG
K081797 06/25/2008 IMAGE STORAGE SYSTEM, MODEL KSS-400 KONAN MEDICAL, INC. GEORGE MYERS
K081637 06/11/2008 LASER IMAGER DRYPRO MODEL 873 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K081587 06/05/2008 KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 KRELL PRECISION (YANG ZHOU) CO., LTD. CHARLIE MACK
K081583 06/05/2008 CLEARFIL SA CEMENT KURARAY MEDICAL INC. KOJI NISHIDA
K081781 06/24/2008 NUWAV LABORIE MEDICAL TECHNOLOGIES, CORP BARBARA MORNET
K081708 06/17/2008 TAXI ENDOSCOPIC GUIDEWIRE LAKE REGION MFG., INC. DEEP PAL
K081705 06/17/2008 LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN LANG DENTAL MFG. CO., INC. CHAH M SHEN
K081552 06/03/2008 SKYLINE 55 LARSEN & TOUBRO LIMITED A B DESHPANDE
K081570 06/04/2008 DPL THERAPY SYSTEM LED TECHNOLOGIES, LLC LEWIS WARD
K081848 06/30/2008 LIPOSE FAT TRANSFER SYSTEM LIPOSE CORP. ALAN CURTIS
K081704 06/17/2008 SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS LUMENIS, INC. TINA MAYER
K081659 06/12/2008 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L MASIMO CORPORATION MARGUERITE THOMLINSON
K081672 06/13/2008 C-INSIGHT MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K081775 06/23/2008 THE MEDCOMP .010 VASCULAR GUIDEWIRES MEDCOMP LISA WEIKERT
K081593 06/06/2008 POWER ASPIRATOR, MODEL LS2 OR LS2DP MEDICAL DEVICE RESOURCE CORP. MEL KIMSEY
K081639 06/11/2008 ICSI CUMULASE MEDICULT A/S RONALD G LEONARDI
K081559 06/03/2008 GENESIS MEDISISS BRANDI JAMES
K081536 06/02/2008 MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED MEDISIZE BV
K081676 06/17/2008 SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K081594 06/06/2008 MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K081804 06/26/2008 PIONEER PLUS CATHETER MEDTRONIC INC. CATHERINE PRIESTLEY
K081784 06/24/2008 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K081573 06/05/2008 MEDTRONIC EXPORT AP CATHETER MEDTRONIC VASCULAR TARA N TURNEY
K081791 06/25/2008 E-Z CLEAN ELECTROSURGICAL ELECTRODE MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K081527 06/02/2008 LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT MILLIPORE CORPORATION ALISHA VU
K081800 06/25/2008 T12S TELEMETRY TRANSMITTER MORTARA INSTRUMENT, INC. LAURA SPIEGELHOFF
K081811 06/26/2008 CARE3 PLUS NAKANISHI, INC. KEITH BARRITT
K081553 06/03/2008 AED BIPOLAR FORCEPS, MODEL 13-1646 NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE M BUTLER
K081851 06/30/2008 NEOSS ACCESS ABUTMENTS NEOSS, LTD. FREDRIK ENGMAN
K081628 06/10/2008 MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO NEW STAR LASERS, INC. NATALIE R VOLLRATH
K081665 06/13/2008 MILLENIUM II NEXT MOBILITY, LLC JOSEPH AZARY
K081792 06/25/2008 SPY ANALYSIS TOOLKIT, MODEL SA9000 NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K081680 06/17/2008 NUCLEUS-X, MODEL 230X NUMED, INC. NICHELLE LAFLESH
K081611 06/09/2008 NUVASIVE COROENT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K081615 06/09/2008 OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN OLYMPUS AMERICA, INC. STEPHANIE G DONNELLY
K081709 06/17/2008 OLYMPUS AFP - ALPHA-FETOPROTEIN OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) STEPHANIE G DONNELLY
K081561 06/03/2008 OSFERION D OLYMPUS TERUMO BIOMATERIALS CORPORATION STACY A KLUESNER
K081776 06/23/2008 CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM OMEGA CRITICAL CARE LIMITED ALAN SHORT
K081770 06/23/2008 BLACK WIDOW ANTERIOR BUTTRESS PLATE OMNI SURGICAL, L.P. JOSHUA KAUFMAN
K081654 06/12/2008 HEM-9000AI OMRON HEALTHCARE, INC. PAUL DRYDEN
K081744 06/19/2008 PASCAL SYNTHESIS DELIVERY SYSTEM OPTIMEDICA CORPORATION JUDY F GORDON
K081543 06/02/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc. LEAH VAN DE WATER
K081786 06/24/2008 ZIOCERA & CONVERTIBLE SYSTEM OSSTEM IMPLANT CO LTD MINJOO KIM
K081575 06/05/2008 HU/HS/HG PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K081749 06/19/2008 AVANTE Z ZIRCONIA (AS)3 BLOCKS PENTRON CERAMICS, INC. CINDY SALTER
K081540 06/02/2008 ZEGRA POSTURE TRAINER PETER FISCHER PETER FISCHER
K081830 06/30/2008 IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 PHADIA AB MARTIN MANN
K081532 06/02/2008 PHARMAJET NEEDLE-FREE INJECTION SYSTEM PHARMAJET, INC. RON BAUER
K081601 06/06/2008 VEO MULTIGAS MONITOR FOR POCKET PC PHASEIN AB DAVID WEISSBURG
K081793 06/25/2008 PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MARKUS STACHA
K081802 06/26/2008 CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. ROB BUTLER
K081661 06/13/2008 HD15 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC.
K081558 06/03/2008 PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC PIONEER SURGICAL TECHNOLOGY JONATHAN GILBERT
K081699 06/17/2008 PLANMECA SOVEREIGN PLANMECA USA, INC. BOB PIENKOWSKI
K081826 06/27/2008 INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K081720 06/18/2008 PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS PRIME HERBS CORPORATION GENEVIEVE HSIA
K081633 06/11/2008 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS PRIMED MEDICAL PRODUCTS INC. RAYMOND G MARUSYK
K081555 06/03/2008 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED PROCTER & GAMBLE CO. LENORE FAULHABER
K081810 06/26/2008 PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL PULPDENT CORPORATION KENNETH J BERK
K081592 06/06/2008 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH BEE HOON
K081756 06/20/2008 OCULAR RESPONSE ANALYZER REICHERT INC. SANDRA BROWN
K081779 06/23/2008 GOLOX-93 RESPIRONICS, INC. ZITA A YURKO
K081539 06/02/2008 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR RICH MOUNTAIN MEDICAL PRODUCTS, INC. MICHELLE SHIH
K081535 06/02/2008 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR RICH MOUNTAIN MEDICAL PRODUCTS, INC. MICHELLE SHIH
K081538 06/02/2008 TUTOPATCH, TUTOMESH RTI BIOLOGICS, INC. TRAVIS AROLA
K081702 06/17/2008 CARBOXYLATE CEM, PHOSPHATE CEM S & C POLYMER GMBH CHRISTIAN BOETTCHER
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K081533 06/02/2008 SENTINEL PLASMAPROTEINS CAL 3X SENTINEL CH. SpA FABIO ROTA
K081734 06/19/2008 SYNGO IMAGING (VERSION V31) SIEMENS AG, MEDICAL SOLUTIONS
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K081643 06/12/2008 DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 SIEMENS HEALTHCARE DIAGNOSTICS YUK-TING LEWIS
K081769 06/23/2008 INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 SIEMENS HEALTHCARE DIAGNOSTICS RADAMES RIESGO
K081732 06/19/2008 INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN A DRAY-LYONS
K081683 06/17/2008 LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 SIEMENS HEALTHCARE DIAGNOSTICS YUK-TING LEWIS
K081716 06/18/2008 ADVIA CENTAUR HAVM ASSAY Siemens Healthcare Diagnostics Inc. MARY SEEGER
K081789 06/25/2008 DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR Siemens Healthcare Diagnostics Inc. HELEN M LEE
K081808 06/26/2008 ACUNAV V ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA INC. SHELLY PEARCE
K081722 06/18/2008 YSIO SIEMENS MEDICAL SOLUTIONS USA, INC. GARY JOHNSON
K081631 06/11/2008 SINTEA BIOTECH PLS MULTI-AXIAL SCREWS SINTEA BIOTECH, INC. DANIELLE WERNIKOWSKI
K081566 06/04/2008 SMITH & NEPHEW OXINIUM DH FEMORAL HEADS SMITH & NEPHEW, INC. JASON SELLS
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K081832 06/27/2008 ENSPLINTCMX CLAVICLE PIN SONOMA ORTHOPEDIC PRODUCTS, INC. CHARLES NELSON
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K081711 06/17/2008 LUCENT MAGNUM+ SPINAL ELEMENTS, INC. KERRI DIMARTINO
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K081719 06/18/2008 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY KIRK JOHNSON
K081814 06/26/2008 REPROCESSED ENT SHAVERS STERILMED, INC. JOSHUA CLARIN
K081586 06/05/2008 REPROCESSED EXTERNAL FIXATION DEVICE STERILMED, INC. JOSHUA CLARIN
K081600 06/06/2008 STERIS RESERT XL TEST STRIP STERIS Corporation JOHN SCOVILLE
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K081747 06/19/2008 MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) ANDREA M TASKER
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K081623 06/10/2008 SYNTHES RIB FIXATION SYSTEM SYNTHES (USA) AMNON TALMOR
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K081610 06/09/2008 SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K081609 06/09/2008 CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 TaiDoc Technology Corporation Yuhua Chen
K081714 06/18/2008 FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM TaiDoc Technology Corporation Yuhua Chen
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K081674 06/17/2008 BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) THE BINDING SITE, LTD. JAY H GELLER
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K081608 06/09/2008 PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) TOBY ORTHOPAEDICS, LLC AL WEISENBORN
K081554 06/03/2008 TOKUYAMA TISSUECARE TOKUYAMA DENTAL CORPORATION KEITH BARRITT
K081707 06/17/2008 AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS TORNIER, INC. JEFF ONDRLA
K081621 06/09/2008 INFX-8000C (INFINIX CC-I AND VC-I) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K081624 06/10/2008 INFX-8000F (INFINIX CSI AND INFINIX DPI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K081852 06/30/2008 TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 TRULY INSTRUMENT LIMITED YANG JIANHAO
K081726 06/18/2008 TYSONBIO LINK HEALTH MANAGEMENT SYSTEM TYSON BIORESEARCH, INC. WEN-HAI TSAI
K081813 06/26/2008 UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM U.S. IMPLANT SOLUTIONS, LLC SCOTT GARRETT
K081846 06/30/2008 GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 VASCULAR SOLUTIONS, INC. CHARMAINE SUTTON
K081560 06/03/2008 VASCUTEK CANNULA GRAFT, MODEL CGS2008S VASCUTEK LTD. KAREN KELSO
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K081591 06/06/2008 NEUCODIA VERISCI CORPORATION GEORGE HU
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K081567 06/04/2008 VERTEBRON SSP CERVICAL PLATING SYSTEM VERTEBRON, INC. LUIS NESPRIDO
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K081725 06/18/2008 ENTERAL PUMP SET, MODEL 20-1010 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K081713 06/17/2008 VERTEBRAL ACCESS SYSTEM BY VIDACARE VIDACARE CORPORATION GRACE HOLLAND
K081585 06/05/2008 ENDOSCOPY VIDEO CAMERA SYSTEM VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS CHRISTINE E NICHOLS
K081799 06/25/2008 GORE TRI-LOBE BALLOON CATHETER W. L. GORE & ASSOCIATES, INC. KANU H VADODARIA
K081748 06/19/2008 ONEPLANT DENTAL IMPLANT SYSTEM WARANTEC CO., LTD. DANIEL KAMM
K081647 06/12/2008 ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS XODUS MEDICAL, INC. BRENDA NIEL
K081590 06/06/2008 YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J YA HORNG ELECTRONIC CO., LTD. STEVEN CHANG
K081759 06/20/2008 NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V ZIMMER GMBH ERIC S PITTMAN
K081850 06/30/2008 BISQUE ZIRCONIA BLANKS, TYPE BYZ ZIRCAR ZIRCONIA, INC. STUART R GOLDMAN
K081574 06/05/2008 ZOLL R SERIES ZOLL MEDICAL CORPORATION EILEEN M BOYLE
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