FDA 510(k) Decisions During May, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K050534 05/20/2005 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES JOANNA DEVELTER
K051213 05/27/2005 PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS ABBOTT LABORATORIES INC ANDREA RUTH
K050546 05/20/2005 ACON +/- MIDSTREAM PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K050593 05/06/2005 ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K051083 05/12/2005 ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K050922 05/18/2005 ANS SCS ACCESSORY KIT ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K042450 05/12/2005 STERRAD NX CHALLENGE PACK ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K050813 05/04/2005 ABC 2 SCREW AESCULAP, INC. KATHY A RACOSKY
K050693 05/26/2005 ACCENT AIR TECHNIQUES, INC. JOSEPH CAREY
K050060 05/04/2005 LAGUNA PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K050557 05/27/2005 AMT NANOCATH AMERICAN MEDICAL TECHNOLOGIES, INC. MICHAEL RENICK
K050654 05/02/2005 AMSINO I.V. START KIT AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050656 05/02/2005 AMSINO SUTURE REMOVAL KIT AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K051060 05/26/2005 ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K043191 05/16/2005 REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH ANGIOLOGICA B. M. SRL ROBERTO MANCA
K050259 05/27/2005 ARTHREX BIO-PIN ARTHREX, INC. ANN WATERHOUSE
K050749 05/12/2005 ARTHREX TAK FAMILY ARTHREX, INC. ANN WATERHOUSE
K050900 05/16/2005 MEDIOSTAR XT ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K051077 05/03/2005 E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 ASEPTICO, INC. GRANT RAMALEY
K050874 05/05/2005 ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE R MANNING
K040145 05/04/2005 ATA HCM MONOPLACE HYPERBARIC SYSTEM ATA HYPERBARIC CHAMBER MANUFACTURING HUMPHREY KILLAM
K051046 05/10/2005 PAINACEA MODEL XR8 INFRARED HEAT LAMP ATLANTIS LUMINESCENT PRODUCTS, LLC JAMES HARVEY KNAUSS
K043249 05/25/2005 ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K050814 05/06/2005 ATRIUM ICAST COVERED STENT ATRIUM MEDICAL CORP. JOSEPH P PAOLO
K051201 05/26/2005 E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY BARCOVIEW LIEVEN DE WANDEL
K050948 05/18/2005 PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB, INC. ANNE ZAVERTNIK
K050495 05/02/2005 EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) BAXTER HEALTHCARE CORP., BIOSCIENCE RON LAGERQUIST
K050632 05/26/2005 ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K050119 05/06/2005 PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT BECKMAN COULTER, INC. KIM WALKER
K050780 05/12/2005 BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML BECTON DICKINSON & CO. LINDA DILLON
K050881 05/12/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML BECTON, DICKINSON & CO. MONICA E GUIGUERE
K050946 05/27/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050865 05/20/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050982 05/24/2005 BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) BECTON, DICKINSON & CO. MONICA E GIGUERE
K041984 05/11/2005 ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT BEST SANITIZERS, INC. RICHARD M ORMSBEE
K051072 05/12/2005 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM BIO-RAD LABORATORIES, INC. WILLIAM G GUSTAFSON
K043067 05/31/2005 ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 BIOARRAY SOLUTIONS LTD KEVIN WYCKOFF
K050596 05/13/2005 QUANTIA A1-AT BIOKIT S.A. JOAN GUIXER
K043005 05/03/2005 MODIFICATION TO MBCP BIOMATLANTE MYRIAM VINCENT
K050816 05/12/2005 VITEK 2 GRAM POSITIVE MEROPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K050976 05/23/2005 VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. NANCY WEAVER
K050251 05/27/2005 BALANCE HIP SYSTEM BIOMET, INC. GARY BAKER
K050961 05/13/2005 RNA1C CONTROL FOR NYCOCARD HBA1C BIONOSTICS, INC. KATHLEEN STORRO
K043542 05/18/2005 BIOPRO TARA FEMORAL RESURFACING COMPONENT BIOPRO, INC. DAVID MRAK
K050305 05/23/2005 ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 BIOSCREEN MEDICAL INC. JIMMY LIANG
K050892 05/11/2005 HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K050684 05/20/2005 ATLANTIS PV BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K050389 05/25/2005 ULTRA-SOFT SV BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. ANGIE BYLAND
K042543 05/17/2005 IPLAN! DIGITAL TEMPLATING BRAINLAB AG RAINER BIRKENBACH
K050996 05/05/2005 O-ARM IMAGING SYSTEM BREAKAWAY IMAGING, LLC WOLFGANG KRULL
K050006 05/27/2005 BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO C.R. BARD, INC. DEBORAH L HERRINGTON
K050185 05/26/2005 POWERHOHN AND POWERLINE CATHETERS C.R. BARD, INC. CHRLES MORREALE
K050875 05/26/2005 U-BALLOON DILATION CATHETER C.R. BARD, INC. JOHN C KNORPP
K050853 05/04/2005 PMP4 SPIROPRO CARD GUARD SCIENTIFIC SURVIVAL, LTD. NA'AMA OREN
K043518 05/11/2005 RADIOPAQUE BONE CEMENT CARDINAL HEALTH SHARON NICHOLS
K051055 05/23/2005 INTRABEAM SYSTEM CARL ZEISS SURGICAL GMBH ROSINA ROBINSON
K050129 05/17/2005 CELLERATION MIST THERAPY SYSTEM 5.1 CELLERATION, INC. DAVID BREMSETH
K050065 05/27/2005 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION PENNY NORTHCUTT, RAC
K051085 05/05/2005 DOPPLER-BOX COMPUMEDICS GERMANY GMGH GEROLD WIDENHORN
K050470 05/06/2005 CONCENTRIC EMBOLIC PEARLS CONCENTRIC MEDICAL, INC. JEAN M CAILLOUETTE
K050829 05/06/2005 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K050923 05/18/2005 LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR CONMED LINVATEC ELIZABETH PAUL
K050246 05/19/2005 SIS DERMAL AUGMENTATION STRAND COOK BIOTECH, INC. MARK BLEYER
K043509 05/05/2005 GUNTHER TULIP VENA CAVA FILTER SET COOK, INC. EARL E KNIGHT III
K050717 05/13/2005 PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC COOPERVISION, INC. BONNIE TSYMBAL
K051081 05/12/2005 ESSENPACS CYMED ENGINEERING, INC. CARL ALLETTO
K050080 05/05/2005 CYNOSUREA ECLILITE AND ECLILITE U CYNOSURE, INC. GEORGE CHO
K050650 05/16/2005 NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 CYTYC SURGICAL PRODUCTS JIM TALBOT
K050665 05/02/2005 N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) DADE BEHRING, INC. DONNA A WOLF
K050610 05/25/2005 SALUTE FIXATION SYSTEM DAVOL INC., SUB. C.R. BARD, INC. LUCINDA L FOX
K050098 05/23/2005 DDAT OMT DDAT(UK) LTD PETER LIOYD
K043330 05/16/2005 POLYPROPILENE SURGICAL SUTURES DEMETECH CORP. ARTHUR WARD
K050959 05/11/2005 DELTON ILLUMINATING PIT AND FISSURE SEALING DENTSPLY INTERNATIONAL HELEN LEWIS
K050315 05/16/2005 DELTA HUMERAL CUPS DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K041059 05/17/2005 EPI-MAX DERMAGENICS, INC. STEVE MONROE
K050888 05/23/2005 INTEGRA IMMOBILIZATION SYSTEM DIACOR, INC. GLENN N WATERMAN
K051232 05/20/2005 D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER DIDECO S.R.L. BARRY SALL
K050890 05/05/2005 ECC.O SYSTEM DIDECO S.R.L. BARRY SALL
K043409 05/05/2005 ACCUCHANGER DIREX SYSTEMS CORP. LARISA GERSTEIN
K042610 05/16/2005 DR. THEISS ALERGOL POLLEN BLOCKER CREAM DR. THEISS NATURWAREN GMBH STUART PORTNOY
K050248 05/25/2005 ELECTRODE ELECTRAMOLD E.W. JOHNSON
K051075 05/27/2005 ENCORE REVERSE SHOULDER PROSTHESIS ENCORE MEDICAL, L.P. CHRISTIE SHUMAKER
K043489 05/19/2005 ENPATH DEFLECTABLE CATHETER ENPATH MEDICAL INCORPORATED KARYL D HASKELL
K050672 05/02/2005 ERCHONIA EVRL LASER ERCHONIA MEDICAL, INC. KEVIN WALLS
K051002 05/17/2005 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K050788 05/13/2005 EVERLIFE EVERLIFE MEDICAL INSTRUMENT CO., LTD. JEN KE-MIN
K050660 05/12/2005 FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K043149 05/25/2005 FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) FIRSTLINE, LLC. COLETTE PERCHES
K050904 05/25/2005 CPAP HUMIDIFIER, MODEL HC238JHU FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K050556 05/11/2005 ALUMINA HEAD FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K050907 05/19/2005 FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P FUJINON, INC. JOSEPH AZARY
K051052 05/06/2005 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) GALIL MEDICAL LTD. JONATHAN S KAHAN
K033262 05/27/2005 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) GAMBRO RENAL PRODUCTS KAE MILLER
K043342 05/27/2005 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR GAMBRO RENAL PRODUCTS KAE MILLER
K051092 05/25/2005 DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC GE HEALTHCARE JOEL C KENT
K050835 05/06/2005 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K050093 05/13/2005 MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K050731 05/19/2005 SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K050943 05/23/2005 GE VIEWPOINT GENERAL ELECTRIC CO. ALLEN SCHUH
K050850 05/26/2005 XPAND CORPECTOMY SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K050071 05/11/2005 MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE H.B.M. USA CO.,INC. GORDON X HU
K050658 05/27/2005 RESO-PAC PERIODONTAL DRESSING HAGER WORLDWIDE, INC. DANIEL J MANELLI
K041360 05/05/2005 ALDAHOL III HIGH-LEVEL DISINFECTANT HEALTHPOINT, LTD. NORM MINER, PHD
K051153 05/18/2005 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) HEBEI MANFUL IMPORT & EXPORT CO., LTD. YANCHAI ZHANG
K051025 05/13/2005 FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM HOLOGIC, INC. DANIEL F PHELAN
K051079 05/19/2005 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY HOSPICARE, INC. YULIYA MATLIN
K050926 05/09/2005 TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 IDEV TECHNOLOGIES, INC. SHANNON HURD
K042431 05/27/2005 PROCON2 INCONTINENT CONTROL DEVICES, INC. NYLE ELLIOTT
K050741 05/16/2005 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT IND DIAGNOSTIC INC. JASON PENG
K051341 05/27/2005 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 INION LTD. HANNA MARTTILA
K050171 05/04/2005 IT NASAL MASK INNOMED TECHNOLOGIES FRANK PELC
K050521 05/02/2005 EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S INNTEC, INC. GARY SYRING
K050715 05/12/2005 QUANTA PLEX ANCA PROFILE INOVA DIAGNOSTICS, INC. BRYS C MYERS
K051182 05/19/2005 INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS INOVEL LLC WILLIAM WAWRZYNIAK
K050661 05/02/2005 HEMOSIL FACTOR II DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050720 05/11/2005 NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 INTEGRA NEUROSCIENCES NANCY A MATHEWSON
K050983 05/16/2005 IRMA TRUPOINT CREATININE CONTROL KIT INTERNATIONAL TECHNIDYNE CORPORATION NANCY RING
K050861 05/27/2005 PEEK CAS INTERPORE CROSS INTL. WENDY SPIELBERGER
K050756 05/05/2005 SKIPPER AND SKIPPER RACE GUIDEWIRE INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. MELISSA SOMMERFELD
K050453 05/27/2005 ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 IVOCLAR VIVADENT, INC. DONNA HARNETT
K050669 05/26/2005 JEIL BONE FIXATION SYSTEM JEIL MEDICAL CORPORATION DANIEL KAMM
K050838 05/04/2005 THE LF-P CERAMIC SYSTEM JENSEN INDUSTRIES, INC. GARY PHELPS
K050130 05/13/2005 KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K050897 05/24/2005 NAVIPRO SHOULDER SOFTWARE MODULE KINAMED, INC. VINEET K SARIN
K050261 05/26/2005 V.A.C. GRANUFOAM SILVER PROTECTION DRESSING KINETIC CONCEPTS, INC. CHRISTY OVIATT
K050051 05/16/2005 ARMAND ENDOSCOPE HOLDER KLS-MARTIN L.P. JENNIFER DAMATO
K043484 05/16/2005 LANX SPINAL FIXATION SYSTEM LANX, LLC DAVID W SCHLERF
K051067 05/27/2005 PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LEMAITRE VASCULAR, INC. AMY WATZKE
K050638 05/31/2005 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES LENSTEC, INC. LUIS RUIZ
K050499 05/17/2005 PROBLOC, HN SERIES AND PROLONG, PL SERIES LIFE-TECH, INC. JEFF KASOFF
K043197 05/20/2005 ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. MARY ELLEN HOLDEN
K050612 05/04/2005 LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE LIGHTSPEED TECHNOLOGY, INC. STEVEN SENIA
K050519 05/17/2005 ADVANCED TURBO DRIVE SYSTEM LINVATEC CORP. ELIZABETH PAUL
K050735 05/23/2005 MC6A MACAN ENGINEERING CO. RICH GARRETT
K050973 05/17/2005 MODIFICATION TO: VOYAGER LINUX MAKO SURGICAL CORP. WILLIAM F TAPIA
K042534 05/10/2005 MARINA MEDICAL FINGER PROTECTORS MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K050252 05/11/2005 AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS MASIMO CORPORATION JAMES J CRONIN
K050332 05/27/2005 SURGI-WRAP MAST BIORESORBABLE SHEET MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K050963 05/20/2005 GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN MDS NORDION ROSS KACHANIWSKY
K051065 05/26/2005 RAYCELL X-RAY BLOOD IRRADIATOR MDS NORDION ROSS KACHANIWSKY
K050934 05/05/2005 MODUS TITANIUM OSTEOSYNTHESIS SYSTEM MEDARTIS, INC. FLOYD G LARSON
K050561 05/04/2005 WINDSURFER MEDCON LTD. ELI M ORBACH
K050873 05/26/2005 CANALIZER HYDROPHILIC GUIDE WIRE MEDICAL DEVICE TECHNOLOGIES, INC. KRISTINE LIBERACKI
K050990 05/02/2005 REMREST HEATED HUMIDIFIER MEDICAL INDUSTRIES AMERICA, INC. KEITH THEISEN
K050993 05/26/2005 MMS VIDEO OPTION MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K051040 05/24/2005 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC PERFUSION SYSTEMS BRUCE BACKLUND
K051039 05/12/2005 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K050981 05/17/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TRECHAME
K050484 05/04/2005 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARME
K050022 05/05/2005 MEDX HOME MEDX ELECTRONICS, INC. ANITA SALTMARCHE
K050924 05/27/2005 MERETE DUOTHREADTM BONE SCREW MERETE MEDICAL GMBH JENIK RADON
K050962 05/06/2005 MERIT PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K041823 05/10/2005 PIONEER U121 SERIES CPAP MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K050812 05/05/2005 90XL INSTRUMENTATION SYSTEM MESA LABORATORIES, INC. TODD ROMERO
K043586 05/06/2005 LASER SYS*STIM 540, MODEL ME 540 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K051090 05/13/2005 X-CHANGE MEYRA KIRK MACKENZIE
K050941 05/05/2005 BRIX WHEELCHAIR MEYRA, INC. KIRK MACKENZIE
K051252 05/27/2005 MICROPUMP MP-101 MICREL MEDICAL DEVICES S.A. ALEXANDRE TSOUKALIS
K051100 05/11/2005 MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K050322 05/17/2005 MICROTEK EQUIPMENT DRAPES MICROTEK MEDICAL, INC. THOMAS BONNER
K050595 05/23/2005 FT2000 SEQUENCER FOR MUSCLE STIMULATOR MIDWEST DEVELOPMENT STEPHEN GORSKI
K043036 05/06/2005 NON-STICK ELECTRODE MODERN MEDICAL EQUIPMENT MFG., LTD. ROBERT STILLMAN
K050786 05/09/2005 BARRIER SURGICAL GOWNS MOLNLYCKE HEALTH CARE JOHN CLAY
K051203 05/25/2005 BLUELEX MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K042595 05/04/2005 SPIRO'AIR MORGAN SCIENTIFIC, INC. PATRICK MORGAN
K050469 05/13/2005 EZ-STIK ELECTRODES NAIMCO, INC. ROBERT L MCCLURE
K050594 05/15/2005 NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE NANO-DITECH CO. SUSAN D GOLDSTEIN-FALK
K042912 05/17/2005 INTERX5000 NEURO RESOURCE GROUP, INC. KRISTA OAKES
K050702 05/17/2005 NEUROSYSTEMS 1TM MONITOR NEUROSYSTEMS LLC JAMES R PETITE JR.
K050882 05/27/2005 NEWDEAL ANKLE NAIL NEWDEAL S.A. JUDITH E O'GRADY
K050312 05/09/2005 AMIGO INSULIN PUMP NIPRO DIABETES SYSTEMS, INC. CLARENCE ODOM
K050014 05/05/2005 HEMONIR TM NIR DIAGNOSTICS, INC. CYNTHIA A SINCLAIR
K050356 05/05/2005 COMPRESSION ANASTOMOSIS RING (CAR) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K050393 05/04/2005 THE GUIDED SURGERY CONCEPT NOBEL BIOCARE AB ELIZABETH J MASON
K050705 05/19/2005 TIUNITE IMPLANTS NOBEL BIOCARE AB HERBERT CRANE
K050920 05/11/2005 CZR PRESS LF STAINS NORITAKE CO., INC. IVAN J WASSERMAN
K041184 05/03/2005 NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION NTI-TSS, INC. JAMES BOYD
K042729 05/17/2005 DERMACYN WOUND IRRIGATION OCULUS INNOVATIVE SCIENCES, INC. MOANISHA DESHMUKH
K041161 05/03/2005 MICROCYN WOUND CARE DRESSING OCULUS INNOVATIVE SCIENCES, INC. MANISHA S DESHMUKH
K042977 05/10/2005 LASIK EYE DRAPE ODYSSEY MEDICAL, INC. IVAN HARLAN
K050503 05/12/2005 SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 OLYMPUS MEDICAL SYSTEMS CORPORATION LARUA STORMS-TYLER
K050541 05/09/2005 OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY OMNIGUIDE COMMUNICATIONS, INC. IRINA KULINETS
K050454 05/27/2005 OMNITECH FULGURATING ELECTRODE OMNITECH SYSTEMS, INC. JON D BARRETT
K050856 05/31/2005 LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM OPHTHOCARE LTD. DORIT WINITZ
K043125 05/04/2005 ORION DIAGNOSTICA UNIQ PINP RIA ORION DIAGNOSTICA OY ANNIKKA RANTAMA
K050868 05/27/2005 MAXLOCK ORTHOHELIX SURGICAL DESIGNS, INC. EDWARD A KROLL
K051181 05/23/2005 CUSTOM-HIP TOOL ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K051032 05/23/2005 TITANIUM-HIP TOOL ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K050680 05/13/2005 BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 OSTAR MEDITECH CORP. STEVEN CHANG
K050929 05/20/2005 THE HERMES SYSTEM PALAISTRA SYSTEMS INC. PATRIC GORA
K050980 05/26/2005 ULTRASONIC BIO-MICROSCOPE, MODEL P60 PARADIGM MEDICAL INDUSTRIES, INC. EDWARD A KROLL
K051170 05/23/2005 GEMINI GXL PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. RAE ANN FARROW
K050573 05/04/2005 NEUROLAC NERVE GUIDE POLYGANICS BV JAN NIEUWENHUIS
K050754 05/18/2005 PRECIMED CANNULATED SCREW SYSTEM PRECIMED, INC. BARBARA LYONS
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