FDA 510(k) Applications Received During March, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K050534 03/02/2005 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES JOANNA DEVELTER
K050552 03/07/2005 PACHPEN PACHYMETER, MODEL 24-5100 ACCUTOME, INC. JEFFREY L WRIGHT
K050546 03/02/2005 ACON +/- MIDSTREAM PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K050593 03/08/2005 ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K050648 03/15/2005 SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK ADVANCED MEDICAL OPTICS, INC. PAM SCHAUB
K050633 03/23/2005 TRIAL CABLE RETENTION CLIP ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K050752 03/31/2005 AESCULAP ORTHOPILOT 2 THA V 2.0 AESCULAP, INC. MATTHEW M HULL
K050804 03/30/2005 MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM AESCULAP, INC. KATHY A RACOSKY
K050810 03/31/2005 AGFA CR50.0 AGFA CORP. JEFFERY A JEDLICKA
K050751 03/23/2005 IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X AGFA CORP. PHIL CUSCUNA
K050693 03/18/2005 ACCENT AIR TECHNIQUES, INC. JOSEPH CAREY
K050729 03/21/2005 ALCON MULTI-PURPOSE DISINFECTING SOLUTION ALCON RESEARCH, LTD. KIM B KRACKE
K050518 03/01/2005 REPROCESSED PHACOEMUISIFICATION TIPS ALLIANCE MEDICAL, INC. ELIZABETH RENKEN
K050553 03/03/2005 NOVEL VBR SPINAL SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K050699 03/18/2005 MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 AMEDICA CORP. ROBERT M WOLFARTH
K050557 03/03/2005 AMT NANOCATH AMERICAN MEDICAL TECHNOLOGIES, INC. MICHAEL RENICK
K050785 03/28/2005 AMSINO ENDOTRACHEAL TUBE AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050654 03/15/2005 AMSINO I.V. START KIT AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050656 03/15/2005 AMSINO SUTURE REMOVAL KIT AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050629 03/11/2005 ANGIOSCULPT SCORING BALLOON CATHETER ANGIOSCORE, INC. GARY GERSHONY
K050551 03/03/2005 VOYAGER PERSONAL IMAGING DEVICE ARDENT SOUND, INC. PETER G BARTHE
K050652 03/15/2005 SPOTCHEM II CREATININE, AMYLASE & ALP TESTS ARKRAY, INC. HELEN LANDICHO
K050790 03/31/2005 SPOTCHEM II LDH TEST ARKRAY, INC. HELEN LANDICHO
K050749 03/23/2005 ARTHREX TAK FAMILY ARTHREX, INC. ANN WATERHOUSE
K050634 03/09/2005 MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC. ANN WATERHOUSE, RAC
K050687 03/23/2005 AXIOM EPS8000 AXIOM WORLDWIDE, INC. JAMES J GIBSON
K050574 03/07/2005 AFINION HBALC AXIS-SHIELD POC AS RONALD G LEONARDI
K050632 03/09/2005 ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K050780 03/28/2005 BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML BECTON DICKINSON & CO. LINDA DILLON
K050555 03/03/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050747 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050745 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050666 03/14/2005 GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K050712 03/17/2005 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K050537 03/02/2005 LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS BIO-RAD SUZANNE S PARSONS
K050536 03/02/2005 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL BIO-RAD MARIA ZEBALLOS
K050682 03/16/2005 LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K050734 03/21/2005 COOL.CLICK BIOJECT, INC. MELANIE TALBERT
K050596 03/08/2005 QUANTIA A1-AT BIOKIT S.A. JOAN GUIXER
K050613 03/10/2005 QUANTIA BETA-2 MICROGLOBULIN BIOKIT S.A. JOAN GUIXER
K050493 03/01/2005 QUANTIA IGE BIOKIT S.A. JOAN GUIXER
K050824 03/31/2005 100W CERALAS D 980 LASER SYSTEM, MODEL D100 BIOLITEC, INC. JONATHAN S KAHAN
K050513 03/01/2005 MDA B.30 BIOMERIEUX, INC. JOCELYN JENNINGS
K050816 03/31/2005 VITEK 2 GRAM POSITIVE MEROPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K050701 03/18/2005 THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K050647 03/14/2005 ALL-IN-ONE BISCO, INC. BENJAMIN LICHTENWALNER
K050805 03/30/2005 30 ML OR 60 ML PEDI-SYRINGE FILTER BLOOD PRODUCTS SPECIALTIES LLC ALAN A WALDMAN
K050630 03/11/2005 PIVOT STEERABLE MICROCATHETER BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K050684 03/17/2005 ATLANTIS PV BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K050577 03/07/2005 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 BOSTON SCIENTIFIC CORP. VERONICA M KOCKEN
K050700 03/18/2005 MATRIX STRETCH RESISTANT (SR) COILS BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K050599 03/09/2005 TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER BOSTON SCIENTIFIC CORP. VICTOR HAM
K050558 03/03/2005 MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F C.R. BARD, INC. KAREN HUTCHISON
K050724 03/21/2005 SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM C.R. BARD, INC. LORRAINE R PATA
K050688 03/17/2005 TEGRESS IMPLANT NEEDLE C.R. BARD, INC. TERRI MORRIS
K050800 03/30/2005 NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K050673 03/15/2005 CANDELA FAMILY OF PULSE DYE LASER SYSTEMS CANDELA CORP. LORRAINE CALZETTA PATROVIC
K050808 03/30/2005 CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 CARDIO-OPTICS, INC. LARRY BLANKENSHIP
K050757 03/23/2005 FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE CHEMENCE MEDICAL INC. SCOTT LEAL
K050758 03/23/2005 CHEMPAQ XBC ANALYZER CHEMPAQ A/S JONATHAN S KAHAN
K050609 03/15/2005 AQUADEX SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K050689 03/17/2005 SURGICAL FACE MASK CHINA SURGICAL DRESSINGS CENTER CO.,LTD MICHAEL F. L CHANG
K050611 03/09/2005 ENDOTINE RIBBON COAPT SYSTEMS, INC. LINDA RUEDY
K050739 03/21/2005 CODMAN VPV SYSTEM, MODEL 82-3192 CODMAN & SHURTLEFF, INC. KAREN F JURCZAK
K050674 03/16/2005 PHYSIOGLOVE ES COMMWELL LTD. JONATHAN S KAHN
K050777 03/28/2005 PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 CONMED CORP. MICHAEL A PATZ
K050578 03/07/2005 COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE COOK IRELAND LTD EMMETT DEVEREUX
K050698 03/17/2005 MODIFICATION TO:ZILVER 518 BILIARY STENT COOK, INC. STEPHANIE ROBERTS
K050717 03/24/2005 PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC COOPERVISION, INC. BONNIE TSYMBAL
K050645 03/14/2005 CORDIS AMIIA .014" PTA BALLOON CATHETER CORDIS CORP. KAREN WILK
K050764 03/25/2005 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS CORIN U.S.A. JOEL BATTS
K050509 03/01/2005 LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I CTI PET SYSTEMS, INC. ALAINE MEDIO
K050679 03/16/2005 CUTERA SOLERA OPUS AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K050793 03/28/2005 LANDLEX MODEL S400X CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN-LAN
K050792 03/28/2005 LANDLEX, MODEL S300X CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN LAN
K050779 03/29/2005 CYNERGY MULTIPLEX LASER CYNOSURE, INC. GEORGE CHO
K050650 03/14/2005 NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 CYTYC SURGICAL PRODUCTS JIM TALBOT
K050695 03/18/2005 FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT DAAVLIN DISTRIBUTING CO. DAVID W SWANSON
K050585 03/08/2005 MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE DADE BEHRING, INC. ROBERT EUSEBIO
K050665 03/15/2005 N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) DADE BEHRING, INC. DONNA A WOLF
K050620 03/10/2005 READMYHEART, MODEL RMH3.0 DAILYCARE BIOMEDICAL INC DANIEL J CHANG
K050626 03/11/2005 GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K050597 03/09/2005 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K050676 03/16/2005 GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) DATEX-OHMEDA, INC. DAN KOSEDNAR
K050610 03/10/2005 SALUTE FIXATION SYSTEM DAVOL INC., SUB. C.R. BARD, INC. LUCINDA L FOX
K050750 03/23/2005 LC BRACKET ADHESIVE SYSTEM DENTSPLY INTL. HELEN LEWIS
K050771 03/28/2005 LUPINE LOOP DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K050675 03/16/2005 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE DEPUY SPINE, INC. LISA GILMAN
K050523 03/02/2005 DIADEXUS PLAC TEST DIADEXUS, INC. JULIE BLACKLOCK
K050590 03/08/2005 ENZY-WELL SYPHILIS IGG, MODEL 91106 DIESSE DIAGNOSTICA SENESE S.P.A GLORIA SCHLANSER
K050710 03/21/2005 MINIMASTER ULTRASONIC SCALER E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J.M. NOLTE
K050627 03/11/2005 LIFESTENT TURBO BILIARY STENT SYSTEMS EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K050563 03/04/2005 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K050672 03/16/2005 ERCHONIA EVRL LASER ERCHONIA MEDICAL, INC. KEVIN WALLS
K050571 03/04/2005 ABSOLUTE AMERICA EURODENT S.P.A. AVI POLITI
K050725 03/21/2005 PROTEGE GPS SELF-EXPANDING NITINOL STENT EV3 CORPORATION GLEN D SMYTHE
K050788 03/28/2005 EVERLIFE EVERLIFE MEDICAL INSTRUMENT CO., LTD. JEN KE-MIN
K050806 03/30/2005 OPTECURE EXACTECH, INC. REBECCA S ROBERTS
K050738 03/17/2005 FT FIBER OPTIC DELIVERY SYSTEMS FIBERTECH GMBH ARMIN KAUS
K050424 03/02/2005 ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 FIM MEDICAL DANIEL KAMM
K050556 03/09/2005 ALUMINA HEAD FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K050575 03/07/2005 FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM FUTUMEDS SDN BHD LEONG PEI PING
K050559 03/03/2005 GE DISCOVERY VCT SYSTEM GE MEDICAL SYSTEMS D DUERSTELER
K050583 03/07/2005 MODEL 250 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K050614 03/10/2005 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K050731 03/21/2005 SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K050704 03/18/2005 MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING GENERAL ELECTRIC CO. JOHN L SCHMIDT
K050664 03/15/2005 SPOR-TEST PA BIOLOGICAL INDICATOR KIT GETINGE USA, INC BARD SMITH
K050713 03/18/2005 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 GOOD BIOTECH CORP. VICTOR CHIOU
K050576 03/07/2005 MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H GOOD BIOTECH CORP. VICTOR CHIOU
K050668 03/15/2005 GRT LITE, MODEL 8-A GRT SOLUTIONS, INC. GEORGE GONZALEZ
K050755 03/23/2005 MODIFICATION TO BVBLUE GRYPHUS DIAGNOSTICS, LLC THOMAS M TSAKERIS
K050550 03/03/2005 GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR GYRUS MEDICAL, INC. MARK JENSEN
K050658 03/15/2005 RESO-PAC PERIODONTAL DRESSING HAGER WORLDWIDE, INC. DANIEL J MANELLI
K050768 03/29/2005 ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 HAMILTON THORNE BIOSCIENCES DIARMAID H DOUGLAS-HAMILTON
K050508 03/02/2005 HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES HAYWOOD VOCATIONAL OPPORTUNITIES TIM KELLEY
K050711 03/18/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT HEALTH & LIFE CO., LTD. PAUL HUNG
K050714 03/18/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS HEALTH & LIFE CO., LTD. PAUL HUNG
K050587 03/08/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM HEALTH & LIFE CO., LTD. PAUL HUNG
K050567 03/04/2005 HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. GEOFFREY CLAPP
K050516 03/03/2005 T-SLING HERNIAMESH S.R.L. LORENA TRABUCCO
K050602 03/09/2005 ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K050721 03/21/2005 ABX ERYTROL HORIBA ABX TIM LAWTON
K050719 03/21/2005 ABX PENTRA DX 120: OPTION SPS EVOLUTION HORIBA ABX TIM LAWTON
K050539 03/02/2005 SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K050512 03/01/2005 STRYKER LOCKED PLATING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K050696 03/21/2005 MEDLITE C1 Q-SWITCHED ND:YAG LASER HOYA PHOTONICS, INC. JIM GREEN
K050772 03/30/2005 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K050465 03/03/2005 IMMUNALYSIS COCAINE ELISA FOR HAIR IMMUNALYSIS CORPORATION MICHAEL VINCENT
K050741 03/21/2005 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT IND DIAGNOSTIC INC. JASON PENG
K050588 03/09/2005 VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM INNOVATIVE SPINAL DESIGN, LLC LEIGH COWDEN
K050521 03/01/2005 EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S INNTEC, INC. GARY SYRING
K050662 03/29/2005 QUANTA LITE SP100 ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K050715 03/18/2005 QUANTA PLEX ANCA PROFILE INOVA DIAGNOSTICS, INC. BRYS C MYERS
K050544 03/02/2005 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050661 03/15/2005 HEMOSIL FACTOR II DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050720 03/21/2005 NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 INTEGRA NEUROSCIENCES NANCY A MATHEWSON
K050496 03/01/2005 REM440 INTERACOUSTICS A/S, ASSENS DANIEL EGGAN
K050538 03/02/2005 IMC DRAPES INTL. MEDSURG CONNECTION, INC. MANNY GUPTA
K050802 03/30/2005 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K050756 03/23/2005 SKIPPER AND SKIPPER RACE GUIDEWIRE INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. MELISSA SOMMERFELD
K050562 03/08/2005 OCULIGHT GL/GLX IRIDEX CORP. JOHN JOSSY
K050716 03/21/2005 ISCIENCE SURGICAL VISCOINJECTOR ISCIENCE SURGICAL CORPORATION JUDY F GORDON
K050690 03/17/2005 CONNEXUS ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K050642 03/11/2005 ORTHOBLAST II PUTTY AND PASTE ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K050669 03/15/2005 JEIL BONE FIXATION SYSTEM JEIL MEDICAL CORPORATION DANIEL KAMM
K050744 03/25/2005 KAVO ERGOCOM/ERGOCAM KAVO AMERICA CORPORATION KANIEL KAMM
K050443 03/01/2005 ACCU-LEAD KENTEC MEDICAL, INC. DAVID SHERATON
K050601 03/16/2005 SMARTDOP 45 VASCULAR DOPPLER KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K050774 03/25/2005 LANX ANTERIOR CERVICAL PLATE SYSTEM LANX, LLC DAVID W SCHLERF
K050638 03/11/2005 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES LENSTEC, INC. LUIS RUIZ
K050586 03/07/2005 LEONE IMPLANT SYSTEM LEONE SPA GREG HOLLAND
K050708 03/18/2005 LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 LERADO OVERSEA LTD. TWN BRANCH (BVI) JEN KE-MIN
K050707 03/18/2005 LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 LERADO OVERSEA LTD. TWN BRANCH (BVI) JEN KE-MIN
K050499 03/01/2005 PROBLOC, HN SERIES AND PROLONG, PL SERIES LIFE-TECH, INC. JEFF KASOFF
K050506 03/02/2005 PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS LIFECORE BIOMEDICAL, INC. RACHEL KENNEDY
K050612 03/10/2005 LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE LIGHTSPEED TECHNOLOGY, INC. STEVEN SENIA
K050733 03/17/2005 OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K050519 03/01/2005 ADVANCED TURBO DRIVE SYSTEM LINVATEC CORP. ELIZABETH PAUL
K050639 03/14/2005 LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM LUMENIS, INC. MARTHA MURARI
K050735 03/21/2005 MC6A MACAN ENGINEERING CO. RICH GARRETT
K050504 03/02/2005 VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS MAINE STANDARDS CO. CHIRSTINE BEACH
K050524 03/14/2005 EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 MARDA MEDICAL, INC. HOWARD SCHRAYER
K050542 03/02/2005 MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER MARIAN MEDICAL, INC. SANDRA WINKLER
K050770 03/25/2005 MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT MCKINLEY MEDICAL LLC RALPH D COOEY
K050561 03/03/2005 WINDSURFER MEDCON LTD. ELI M ORBACH
K050490 03/02/2005 OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER MEDICREA J.D. WEBB
K050703 03/18/2005 QBRAIN MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K050584 03/07/2005 GS-128 GRADIENT COMPRESSION SYSTEM MEDMARK TECHNOLOGIES, LLC MARK HIGGINS
K050651 03/14/2005 MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION MEDTRONIC NAVIGATION, INC. TINA DREILING
K050809 03/31/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K050579 03/07/2005 MEGA POWER ELECTROSURGICAL GENERATOR MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K050560 03/10/2005 EUROCHAIR MEYRA, INC. KIRK L MACKENZIE
K050543 03/04/2005 NEXUS DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K050740 03/22/2005 MICROWARE 200 MICROWARE INC MICHAEL B MCGRAW
K050595 03/08/2005 FT2000 SEQUENCER FOR MUSCLE STIMULATOR MIDWEST DEVELOPMENT STEPHEN GORSKI
K050570 03/08/2005 MILTEX RIGID STERILIZATION CONTAINER SYSTEM MILTEX, INC. LEE ZAGAR
K050776 03/28/2005 AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. RONALD R MANNA
K050622 03/10/2005 HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL MRI DEVICES CORPORATION THOMAS SCHUBERT
K050514 03/01/2005 MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS MRI DEVICES CORPORATION THOMAS SCHUBERT
K050621 03/10/2005 NVA-127-8-A NEUROVASCULAR ARRAY COIL MRI DEVICES CORPORATION THOMAS SCHUBERT
K050765 03/24/2005 LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE N.S. UNI-GLOVES SDN. BHD. KENNETH J STANTON
K050469 03/09/2005 EZ-STIK ELECTRODES NAIMCO, INC. ROBERT L MCCLURE
K050594 03/08/2005 NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE NANO-DITECH CO. SUSAN D GOLDSTEIN-FALK
K050737 03/21/2005 NEOTHERMIA EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION DAVID JACOBS
K050603 03/09/2005 OLPUR DIALYZER, MODEL HD 190 NEPHROS, INC. NADIA C GREENIDGE
K050702 03/18/2005 NEUROSYSTEMS 1TM MONITOR NEUROSYSTEMS LLC JAMES R PETITE JR.
K050784 03/28/2005 NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS XIE QIYI
K050697 03/18/2005 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. LYNETTE HOWARD
K050705 03/18/2005 TIUNITE IMPLANTS NOBEL BIOCARE AB HERBERT CRANE
K050641 03/14/2005 ZYGOMA TIUNITE NOBEL BIOCARE USA LLC ELIZABETH MASON
K050649 03/16/2005 SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. WILLIAM F MCNALLY
K050726 03/18/2005 SILVERSEAL SILVERAID WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K050727 03/21/2005 MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. NORMA LEMAY
K050525 03/02/2005 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. NORMA LEMAY
K050541 03/02/2005 OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY OMNIGUIDE COMMUNICATIONS, INC. IRINA KULINETS
K050454 03/08/2005 OMNITECH FULGURATING ELECTRODE OMNITECH SYSTEMS, INC. JON D BARRETT
K050807 03/31/2005 20G SMA LASER FIBER, MODEL LF100 OPHTHALMED LLC JAY MANSOUR
K050637 03/11/2005 ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K050568 03/04/2005 ORLUS MINI SCREW ORTHOLUTION CO., LTD. CATHRYN N CAMBRIA
K050795 03/29/2005 IMBIBE BONE MARROW ASPIRATION NEEDLE ORTHOVITA, INC. JANICE M HOGAN
K050680 03/16/2005 BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 OSTAR MEDITECH CORP. STEVEN CHANG
K050742 03/22/2005 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K050692 03/17/2005 FLXIS PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K050762 03/24/2005 PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH EGON PFEIL
K050573 03/11/2005 NEUROLAC NERVE GUIDE POLYGANICS BV JAN NIEUWENHUIS
K050794 03/30/2005 ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER POSSIS MEDICAL, INC. MARK STENOIEN
K050754 03/28/2005 PRECIMED CANNULATED SCREW SYSTEM PRECIMED, INC. BARBARA LYONS
K050488 03/01/2005 TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES PROSURG, INC. ASHVIN DESAI
K050678 03/16/2005 MOTIFMESH SOFT TISSUE PATCH PROXY BIOMEDICAL LTD. ELAINE DUNCAN
K050691 03/17/2005 R. POON MEDICAL PRODUCTS WHEELCHAIRS R. POON MEDICAL PRODUCTS CO., LTD. RICHARD GRAVER
K050667 03/15/2005 R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE R2 TECHNOLOGY, INC. RICHARD BALL
K050591 03/08/2005 MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY-HANN
K050767 03/25/2005 STERLING INTERFERENCE SCREW ST REGENERATION TECHNOLOGIES, INC. CARRIE HARTILL
K050533 03/03/2005 ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE REGENT MEDICAL AMERICAS, LLC KATHLEEN HARRIS
K050775 03/28/2005 RESSCAN RESMED LTD. DAVID D'CRUZ
K050759 03/24/2005 BIPAP AUTO RESPIRONICS, INC. ZITA A YURKO
K050760 03/24/2005 ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K050748 03/22/2005 ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 SCANTIBODIES LABORATORY, INC. MICHAEL NORDSTROM
K050686 03/16/2005 CARDIOVIT AT-10PLUS SCHILLER AG MARKUS BUETLER
K050778 03/28/2005 TELEREHAD 2004 SCOTTCARE WAYNE STRIPE
K050736 03/21/2005 IMORGON ULTRASOUND PACS SOLUTIONS SEA RIDGE SOFTWARE, INC. GARY J ALLSEBROOK
K050510 03/01/2005 ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 SHIMADZU MEDICAL SYSTEMS RANDAL WALKER
K050797 03/29/2005 TISSU-TRANS SHIPPERT MEDICAL TECHNOLOGIES CORP. SARAH LAKE
K050598 03/09/2005 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) SMART GLOVE CORP. SDN BHD FOO KHON PU
K050580 03/07/2005 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS SMITH & NEPHEW ENDOSCOPY, INC. KATHLEEN BURNS
K050592 03/08/2005 SOMNOMED MAS RXA SOMNOMED LTD ELAINE DUNCAN
K050605 03/15/2005 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 SPACELABS MEDICAL INC. AL VAN HOUDT
K050600 03/10/2005 MINILOC SAFETY INFUSION SET SPECIALIZED HEALTH PRODUCTS, INTL. MARK NELSON
K050532 03/02/2005 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050526 03/02/2005 POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050529 03/02/2005 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050530 03/02/2005 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050528 03/02/2005 POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050527 03/02/2005 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050531 03/02/2005 POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050706 03/18/2005 HARMONY PORT SYSTEM, MODEL 1907 SERIES SPINAL CONCEPTS, INC. NOAH BARTSCH
K050515 03/01/2005 BONE BLOCK FIXATION SET STRAUMANN USA, INC. LINDA JALBERT
K050753 03/23/2005 STRYKER DISCMONITOR STRYKER INSTRUMENTS JEAN W SHEPPARD
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K050615 03/09/2005 STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 STRYKER INSTRUMENTS BECKY DITTY
K050624 03/11/2005 STRYKER SPINE AVS PL PEEK SPACER STRYKER SPINE SIMONA VOIC
K050548 03/02/2005 CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K050671 03/15/2005 ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM SURGRX, INC. LINDA OLESON
K050625 03/11/2005 VARELISA RECOMBI ANA PROFILE, MODEL 18496 SWEDEN DIAGNOSTICS (GERMANY) GMBH SABINE KLUGBAUER
K050604 03/09/2005 KERR VPS IMPRESSION MATERIAL SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K050796 03/29/2005 AURORA DS, DS APPLICATOR SYNERON MEDICAL LTD. AMIR WALDMAN
K050646 03/14/2005 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA) KATHY ANDERSON
K050683 03/17/2005 SYNTHES (USA) 3.5MM CONICAL SCREWS SYNTHES (USA) KATHY ANDERSON
K050631 03/11/2005 SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION SYNTHES (USA) SHERI L MUSGNUNG
K050606 03/10/2005 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) SYNTHES (USA) KATHY ANDERSON
K050607 03/10/2005 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) SYNTHES (USA) KATHY ANDERSON
K050636 03/11/2005 SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS SYNTHES (USA) SHERI L MUSGNUNG
K050608 03/10/2005 SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K050589 03/09/2005 RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K050517 03/01/2005 JSZ-MULTIPURPOSE SOLUTION SZABOCSIK AND ASSOCIATES JOHN MSZABOCSIK
K050628 03/11/2005 ANSPACH COUPLER THE ANSPACH EFFORT, INC. WILLIAM G CONETY
K050670 03/15/2005 SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS TMS TELEMEDIZINISCHE SYSTEME GMBH TILO BORCHARDT
K050619 03/10/2005 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K050616 03/10/2005 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K050617 03/10/2005 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K050663 03/15/2005 TRAXYLOC-1 SYSTEM TRAXYZ MEDICAL, INC. F. DAVID ROTHKOPF
K050681 03/16/2005 OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES TRIMED, INC. KELLI ANDERSON
K050540 03/02/2005 UCP RAPID DRUG SCREENING TESTS UCP BIOSCIENCES, INC. NANCY CHEN
K050730 03/21/2005 MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC. TAMMY LAVERY
K050743 03/21/2005 AQUAFLEX 2 (TEFILCON) CONTACT LENS UNILENS CORP., USA JOSEPHA BRUNO
K050653 03/11/2005 TRANSEAR BONE CONDUCTION HEARING AID UNITED HEARING SYSTEMS, INC. RALPH CAMPAGNA
K050644 03/21/2005 VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT VANCOUVER BIOTECH LTD. ANDREW LEE
K050763 03/24/2005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K050511 03/02/2005 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K050803 03/30/2005 PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES VITAID, LTD. PAUL E DRYDEN
K050623 03/10/2005 VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D VOLK OPTICAL, INC. RICHARD E LIPPMAN
K050709 03/18/2005 RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 WALLAC OY RAIJA KOSKIVAARA
K050819 03/31/2005 CHARLOTTE SNAP-OFF SCREW WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K050801 03/30/2005 URISCAN OPTIMA II URINE ANALYZER YD DIAGNOSTICS JERRI HOI
K050769 03/31/2005 QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 Z-MEDICA CORPORATION ROBERT V PACKARD
K050766 03/25/2005 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM ZIMMER TRABECULAR MARCI HALEVI
K050723 03/21/2005 MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS ZIMMER, INC. TONI KINGSLEY
K050761 03/24/2005 ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM ZIMMER, INC. DARLENE BINKLEY
K050821 03/31/2005 COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM ZYCARE STEVE D HOLDAWAY


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