FDA 510(k) Applications Received During July, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K041934 07/19/2004 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY GINGER CANTOR
K041811 07/06/2004 ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES MARGARET PROCHNIAK
K041962 07/22/2004 XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K041822 07/06/2004 ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K041946 07/19/2004 ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K041858 07/09/2004 ACUMED ANATOMIC RADIAL HEAD SYSTEM ACUMED LLC ED BOEHMER
K041855 07/09/2004 PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S AEARO CO. ANN PHILLIPS
K041854 07/27/2004 MPM SYSTEM AEROTEL MEDICAL SYSTEMS, LTD. GEORGE MYERS
K041916 07/16/2004 ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM ALOKA CO. LTD USA RICHARD J CEHOVSKY
K041963 07/21/2004 AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI AMERICAN BANTEX CORP. TRACY S BEST
K041712 07/12/2004 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K041948 07/20/2004 SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS AMERICAN MEDICAL SYSTEMS, INC. KRISTYN BENSON
K041828 07/07/2004 APEX MEDICAL CPAP MODEL 9S-003 APEX MEDICAL CORP. ALAN CHANG
K041950 07/20/2004 APEX K2 HIP SYSTEM APEX SURGICAL, LLC. EDWARD J CHEAL, PH.D
K041795 07/02/2004 MODIFICATION TO OPTICAL SEPARATOR SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K041782 07/01/2004 SEEMOR 5.0 IMAGE DISPLAY PROGRAM AREEDA ASSOC., LTD. JOSEPH AREEDA
K041965 07/21/2004 ARTHREX HUMERAL FRACTURE PLATES AND SCREWS ARTHREX, INC. SALLY FOUST
K041866 07/09/2004 ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) AXIS-SHIELD DIAGNOSTICS, LTD. SUSAN LEONARD
K041698 07/07/2004 AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. HOWARD SCHRAYER
K041998 07/26/2004 PHACO CHOP NEEDLES BAUSCH & LOMB, INC. DENNIS POZZO
K041889 07/12/2004 TRI-OSTETIC BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K041984 07/23/2004 ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT BEST SANITIZERS, INC. RICHARD M ORMSBEE
K041938 07/19/2004 MAXIMUS OS (OVERDENTURE SYSTEM) BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K041982 07/23/2004 VITEK 2 GRAM NEGATIVE ERTAPENEM BIOMERIEUX, INC. NANCY WEAVER
K041872 07/09/2004 ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K041850 07/08/2004 MEDALLION MODULAR HIP SYSTEM BIOMET MANUFACTURING, INC. LONNIE WITHAM
K042051 07/30/2004 ARCOMXL POLYETHYLENE LINERS BIOMET, INC. TRACY J BICKEL
K041988 07/23/2004 ARTHROTEK MENISCAL HYBRID DEVICE BIOMET, INC. GARY BAKER
K042037 07/29/2004 M2A MAGNUM SYSTEM BIOMET, INC. KACY ARNOLD
K042032 07/28/2004 MAESTRO TOTAL WRIST BIOMET, INC. PATRICIA SANDBORN BERES
K042029 07/28/2004 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K041936 07/28/2004 BIOPRO SUBTALAR IMPLANT BIOPRO, INC. DAVID MRAK
K041970 07/22/2004 BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML BIOTOP TECHNOLOGY CO., LTD. KE-MIN JEN
K041939 07/19/2004 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K041827 07/07/2004 DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K041818 07/06/2004 SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K041993 07/23/2004 2 CM PERIPHERAL CUTTING BALOON BOSTON SCIENTIFIC IVT RENUKA KRISHNAN
K041899 07/14/2004 VECTORVISION UNI-KNEE BRAINLAB AG RAINER BIRKENBACH
K042036 07/29/2004 AIRGUARD VALVED INTRODUCER C.R. BARD, INC. GLENN NORTON
K042026 07/28/2004 BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 C.R. BARD, INC. KAREN S GWOZDOWSKI GAUVIN
K041783 07/01/2004 POLAR WAND CHEK-MED SYSTEMS ROB WHALEN
K041791 07/06/2004 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) CHF SOLUTIONS, INC. AMY PETERSON
K041820 07/19/2004 SOLO-CARE AQUA ANTIMICROBIAL LENS CASE CIBA VISION CORPORATION STEVEN DOWDLEY
K041773 07/01/2004 OXYGEN MEDICELS, CITICELS CITY TECHNOLOGY LIMITED DEBRA WALLACE
K042058 07/30/2004 ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN CLEMENT CLARKE INTL., LTD. PHILIP HALLYBONE
K042039 07/29/2004 FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K041919 07/30/2004 PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 CLINICO REINHARD HOPF
K041898 07/14/2004 CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM CLINIQA CORPORATION CAROL RUGGIERO
K041835 07/07/2004 ENDOTINE MIDFACE B 4.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K041953 07/27/2004 VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART CONMED CORP. IRA DUESLER
K041868 07/09/2004 VALUPEN,PROFILE CONMED CORPORATION PAMELA VETTER
K041833 07/07/2004 CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER CONSOLIDATED MACHINE CORP. ARTHUR TRAPOTSIS
K041849 07/13/2004 TURBO-FLO PICC COOK, INC. EARL E KNIGHT III
K041796 07/06/2004 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORPORATION ELENA S JUGO
K041894 07/15/2004 ORTHOFIBER CP MEDICAL MARY ANN GREENAWALT
K041890 07/13/2004 CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 CRYOCOR, INC. JAMI MILLER
K041994 07/23/2004 MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD JONATHAN S KAHN
K041870 07/13/2004 N APOLIPOPROTEIN STANDARD SERUM DADE BEHRING, INC. DONNA A WOLF
K041878 07/15/2004 N LATEX CYSTATIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K042016 07/27/2004 DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER DATASCOPE CORP. PATRICE NAPODA
K041907 07/15/2004 TRIO MONITOR DATASCOPE CORP. SUSAN E MANDY
K041772 07/01/2004 DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K041790 07/02/2004 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE DATEX-OHMEDA JOEL C KENT
K041775 07/06/2004 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K042022 07/28/2004 E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER DATRIX, INC. DBA OF JON BARRON, INC. LAURA M LUHMANN
K041806 07/06/2004 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K041801 07/02/2004 EXPEDIUM MIS SPINE SYSTEM DEPUY SPINE, INC. JENNIFER MOONEY
K041928 07/19/2004 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041926 07/19/2004 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041927 07/19/2004 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041957 07/21/2004 EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS DIOMED, INC. MAUREEN O'CONNELL
K041960 07/21/2004 COMPOSITE/COMPOMER REPAIR KIT DMG USA, INC. PAMELA PAPINEAU
K041935 07/19/2004 DR SYSTEMS PACS, RELEASE 6.1 DR. SYSTEMS, INC. KIMBERLY J MEADE
K042003 07/26/2004 INFINITY TRIDENT NMT POD DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K041956 07/21/2004 EMG - ESSENTIAL GAS MODULE, MODEL M1013A DRAEGET MEDICAL AG & CO. KGAA JAMES J BRENNAN
K041915 07/16/2004 HEMO-DOP DWL ELEKTRONISCHE SYSTEME GMBH GEROLD WIDENHORN
K041826 07/07/2004 EKOS ULTRASOUND INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K042002 07/26/2004 SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER ELA MEDICAL INC SUSAN OLIVE
K042008 07/26/2004 ULTRAVISUAL EMAGEON UV, INC. INGER COUTURE
K042057 07/30/2004 INFINITY ELECTROTHERAPY SYSTEM EMPI MARY MCNAMARA-CULLINANE
K041920 07/16/2004 INFINITY PLUS ELECTROTHERAPY SYSTEM EMPI MARY MCNAMARA-CULLINANE
K041808 07/13/2004 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K041708 07/07/2004 ENPATH SAFETY INTRODUCER ENPATH MEDICAL INCORPORATED KARYL HASKELL
K042017 07/27/2004 BAHA DIVINO ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE G BUNDY
K041843 07/13/2004 PENCIL POINT NEEDLE EPIMED INTERNATIONAL, INC. CHRIS LAKE
K041906 07/15/2004 EXACTECH 12/14 TOTAL HIP SYSTEM EXACTECH, INC. GARY J MILLER
K042021 07/28/2004 EXACTECH EQUINOXE SHOULDER SYSTEM EXACTECH, INC. GARY MILLER
K041869 07/09/2004 SELF RETAINING BICANALICULUS INTUBATION SET FCI OPHTHALMICS, INC. LOUIS ARMAND
K041900 07/14/2004 HC604 CPAP HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K041829 07/12/2004 FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS FOCUS MEDICAL, LLC. JOHN LEE
K041814 07/06/2004 FS SERIES WHEELCHAIR FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) PANG JIANXUN
K041792 07/02/2004 FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K042023 07/28/2004 FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K041990 07/23/2004 FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K041903 07/14/2004 FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 FUJINON, INC. JOSEPH M AZARY
K042043 07/29/2004 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 FUJINON, INC. JOSEPH M AZARY
K041824 07/06/2004 X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM FUTURE MEDICAL SYSTEMS, SA PATRICK JANIN
K041813 07/06/2004 GE LOGIQ 7 ULTRASOUND BT04 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA ALLEN SCHUH
K042053 07/30/2004 INNOVA 4100, INNOVA 3100 GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K041921 07/16/2004 GE SIGNA PROFILE 6 INCH GP COIL GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K041932 07/19/2004 OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K041931 07/19/2004 OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K041922 07/16/2004 GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR GENERAL ELECTRIC CO. DAVID DUERSTELER
K041945 07/20/2004 POWDER-FREE BLUE VINYL EXAM GLOVES GLORMED INTL., INC. JANNA P TUCKER
K042030 07/28/2004 HYPROCURE SUBTALAR IMPLANT SYSTEM GRAHAM MEDICAL TECHNOLOGIES, L.L.C. MICHAEL GRAHAM
K041718 07/19/2004 KELES FACEMASK GREAT LAKES ORTHODONTICS, LTD. DAVE GRAVER
K041762 07/01/2004 FINISHING WIRE SUPPORTRAK GUIDANT CORPORATION JENNIFER TANG
K041981 07/23/2004 GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 GUIDANT CORPORATION M. LAURIE WONG
K041781 07/01/2004 VENTILAIR II MEDICAL AIR COMPRESSOR HAMILTON MEDICAL AG J. DAVID THOMPSON
K041694 07/06/2004 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041692 07/06/2004 INFRARED EAR THERMOMETER, ET-100 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041693 07/06/2004 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041877 07/12/2004 ACU-STRAP MOTION SICKNESS BAND HEALTH ENT., INC. DANIEL J DILLON
K042033 07/29/2004 HOVEROUND POWER WHEELCHAIR, MODEL HD700 HOVEROUND CORP. TONY DIGIOVANNI
K041940 07/19/2004 HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP TERRY SHERIDAN POWELL
K042019 07/27/2004 HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K042020 07/27/2004 SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) HUTCHINSON TECHNOLOGY, INC. THOMAS A DOLD
K041867 07/19/2004 HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N HYGIA HEALTH SERVICES, INC. TRACY WOOD COMAS
K041881 07/12/2004 ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K041817 07/06/2004 WEST NILE DETECT IGM ELISA INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K041838 07/07/2004 MPS (OR MPS-T) INNERSPACE, INC. DONALD E BOBO
K041837 07/07/2004 INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED INNOLATEX SDN. BHD ELI J CARTER
K041947 07/20/2004 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND INNOVATIVE IMAGING, INC. CYNTHIA KENDALL
K041905 07/15/2004 HEMOSIL CALIBRATION PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K041794 07/02/2004 C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K041893 07/13/2004 INTRALASE FS LASER INTRALASE CORP. CHARLINE GAUTHIER
K041973 07/22/2004 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K041918 07/16/2004 INTEGRATED PATIENT MONITORING SYSTEM INVIVO RESEARCH, INC. NEIL BATTISTE
K041930 07/19/2004 VARILITE LASER SYSTEM IRIDEX CORPORATION JOHN JOSSY
K041991 07/23/2004 ASPIREX - BONE MARROW ASPIRATE KIT ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K042056 07/30/2004 AZ ULTRASONIC SYSTEM J. MORITA USA, INC. HOWARD ROWE
K041912 07/19/2004 SCB/VALLEYLAB FORCE FX INTERFACE UNIT KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S CHEN
K041914 07/16/2004 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER KENDALL JIM WELSH
K041923 07/16/2004 BIOBLANKET KENSEY NASH CORP. DEBORAH RACIOPPI
K042040 07/29/2004 TRIACTIV SYSTEM KENSEY NASH CORP. ROBIN M FATZINGER
K041378 07/21/2004 BIO 60 KODENT, INC. DAE KYU CHANG
K041883 07/12/2004 SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 LEONHARD LANG GMBH ELAINE DUNCAN
K041975 07/22/2004 VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 MAINE STANDARDS CO. CHRISTINE BEACH
K041819 07/06/2004 GOODKNIGHT 425, MODELM-114500-00 MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K041902 07/14/2004 MANTRA ELECTRODE MANTRA INTL. (HK) LTD. ROBERT B SPERTELL
K041815 07/06/2004 LNCS OXIMETRY SENSORS MASIMO CORP. JAMES J CRONIN
K041778 07/01/2004 REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T MAXI-AIDS, INC. ELLIOT ZARETSKY
K041974 07/26/2004 MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER MED2000 S.R.L. SUSAN D GOLDSTEIN-FALK
K041904 07/15/2004 COMPASS F10 SYSTEM MEDCARE FLAGA BERGLIND HALLGRIMSDOTTIR
K041964 07/21/2004 MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS MEDIAID INC. KRISTA OAKES
K041780 07/01/2004 NEW BRID MEDICAL IMAGING SOLUTIONS, INC. NANCY BUTCHER
K041839 07/20/2004 8NONE MEDICAL SOLUTIONS, INC. E.J. SMITH
K041807 07/06/2004 LUNG CAR 1.1 MEDICSIGHT CAROL MACDONALD
K041789 07/02/2004 NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T MEDITEC CO., LTD. RONALD D ARKIN
K041885 07/12/2004 BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS MEDITECH INTERNATIONAL, INC. RICHARD KEEN
K041908 07/15/2004 CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) MEDOC LTD. ADVANCED MEDICAL SYSTEMS TRACY GRAY
K041980 07/23/2004 MSI S-500L RF GENERATOR MEDSPHERE INTERNATIONAL, INC ERIC KAO
K041830 07/07/2004 MAGELLAN RATIO DISPENSER KIT MEDTRONIC PERFUSION SYSTEMS BRUCE BACKLUND
K041862 07/09/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041777 07/01/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042025 07/28/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K041985 07/23/2004 XPS CURVED BUR MEDTRONIC XOMED, INC. MARTIN D SARGENT
K041840 07/08/2004 MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM MEDX, INC. FLOYD R ROWAN
K041823 07/06/2004 PIONEER U121 SERIES CPAP MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K042013 07/27/2004 DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K042060 07/30/2004 EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE MILLIMED A/S JUDITH DANIELSON
K041852 07/08/2004 MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 MINRAD, INC. JOHN MCNEIRNEY
K041846 07/08/2004 SABRESOURCE DRAPE MINRAD, INC. JOHN MCNEIRNEY
K041805 07/06/2004 MICROSCOPE SYSTEM MIRAS MIRROR IMAGING SOLUTIONS, LTD. DORIT WINITZ PH.D.
K042000 07/28/2004 MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS MSQ (M2) LTD. ANNE WORDEN
K041884 07/12/2004 MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS MUELLER WATER CONDITIONING, INC. DAVID W MUELLER
K041786 07/06/2004 CALCAMEA PLATE NEWDEAL S.A. NORMA F ESTRIN
K041704 07/19/2004 NEWGEL AND NEWGEL PLUS E NEWMEDICAL TECHNOLOGY, INC. HAITHAM MATLOUB
K041844 07/09/2004 ALL SAFE HUBER SAFETY INFUSION SETS NEXUS MEDICAL, LLC AL BOEDEKER
K041861 07/09/2004 NEXUS INTRAVENOUS TUBING SETS ("NIVTS") NEXUS MEDICAL, LLC AL BOEDEKER
K041845 07/09/2004 NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 NEXUS MEDICAL, LLC AL BOEDEKER
K041779 07/01/2004 NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L NIPRO MEDICAL CORP. KAELYN B HADLEY
K041751 07/06/2004 COMPRESSION ANASTOMOSIS CLIP (CAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K041876 07/21/2004 NOBELDIRECT OD IMPLANT NOBEL BIOCARE UAS INC ELIZABETH J MASON
K041901 07/14/2004 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER NORTHEAST MONITORING, INC. JOSEPH AZARY
K041933 07/19/2004 MICROSELECTRON PDR NUCLETRON CORP. LISA DIMMICK
K042034 07/29/2004 NUVASIVE MAXCESS LIGHT GUIDE NUVASIVE, INC. LAETITIA COUSIN
K042045 07/30/2004 NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC. NORMA LEMAY
K041793 07/02/2004 OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 OLYMPUS AMERICA, INC. BEV HARDING
K041983 07/23/2004 OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 OPTICON MEDICAL GLENN D BRUNNER
K042001 07/27/2004 PANORAMIC 200A OPTOS PLC HOWARD M HOLSTEIN
K042031 07/28/2004 OPUS SPEEDSTITCH SUTURE DEVICE OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K042006 07/26/2004 VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K041799 07/02/2004 VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS ORTHO-CLINICAL DIAGNOSTICS, INC. CAREY MAYO
K041863 07/09/2004 VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A HANNA
K041809 07/13/2004 PERMANENT PACING LEAD, MODEL PY2 OSCOR INC. MILA DOSKOCIL
K041879 07/12/2004 PALOMAR LUX1064 HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K041776 07/01/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
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