FDA 510(k) Applications Received During June, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K032001 06/27/2003 POLY Q (GARANT L, PENTA M, PENTA H) 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K031758 06/06/2003 ACMI M4 TELESCOPES ACMI CORPORATION GABRIEL J MURACA
K031759 06/06/2003 ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD ACON LABORATORIES, INC. EDWARD TUNG
K031784 06/10/2003 ACON STREP A RAPID TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K031905 06/20/2003 DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 ACTHERM, INC. RICHARD HSIEH
K031705 06/02/2003 SKYLIGHT IMAGING SYSTEM ADAC LABORATORIES COLEEN A COLEMAN
K031872 06/17/2003 ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] ADAC LABORATORIES CHARLENE BRUMBAUGH
K031996 06/27/2003 EXTENTRAC ELITE ADVANCED BACK TECHNOLOGIES DAVID F CUCCIA
K032349 06/30/2003 PLACER ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K031810 06/12/2003 AMPLATZER VASCULAR PLUG AGA MEDICAL CORP. PATRICE M STROMBERG
K031741 06/04/2003 MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K031711 06/02/2003 TANGO, MODELS, BP1 AMERICAN BANTEX CORP. TRACY S BEST
K032003 06/27/2003 PREMIER PLUS AMERICAN IMEX ALEX FONG
K031978 06/26/2003 AMPLAID A756 SCREENING ADMITTANCE METER AMPLAID DANIEL KAMM
K031710 06/02/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K031715 06/02/2003 ARIOL HER-2/NEU IHC APPLIED IMAGING CORP. DIANE C OATES
K031889 06/18/2003 ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES CORP. MARY JO STEGWELL
K031944 06/24/2003 VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K031913 06/20/2003 VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K031945 06/24/2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC. ANN WATERHOUSE
K031937 06/23/2003 ALANTECH GRAFT FIXATION SCREW ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031859 06/16/2003 CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. ROBERT J MICHALIK
K031972 06/26/2003 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K031974 06/26/2003 ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K031716 06/03/2003 SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE ASIA-MED GMBH AND CO KG Kevin Walls
K031694 06/02/2003 MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K031923 06/23/2003 ULTRASITE VALVE B. BRAUN MEDICAL, INC. SHERI L MUSGNUNG
K031882 06/18/2003 ENDOSCOPIC APPLICATOR BAXTER HEALTHCARE CORP. LORI DONDIEGO
K031857 06/16/2003 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K031947 06/24/2003 BAYER CLINITEK STATUS ANALYZER BAYER HEALTHCARE, LLC MARY E GRAY
K031950 06/24/2003 BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD BAYLIS MEDICAL CO., INC. KRIS SHAH
K031949 06/24/2003 TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 BAYLIS MEDICAL CO., INC. AMANDA HARTLEY
K031951 06/24/2003 TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 BAYLIS MEDICAL CO., INC. KRIS SHAH
K031742 06/04/2003 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER BCI, INC. DONALD J ALEXANDER
K032013 06/30/2003 COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER BECKMAN COULTER, INC. LOURDES COBA
K032000 06/10/2003 COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K031870 06/17/2003 SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K031912 06/20/2003 BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML BECTON, DICKINSON & CO. MICHELLE B BANDY
K031943 06/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K031699 06/02/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K031984 06/26/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K031909 06/20/2003 BETEC RETRACTABLE SAFETY SYRINGE (5ML) BETEC MEDICAL SCIENCE CO., LTD. JENNIFER REICH
K031851 06/16/2003 DENTISEPTIC HPC BETHEL, INC ERIC WADE
K032017 06/30/2003 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 BIO-RAD MARIA ZEBALLOS
K031838 06/16/2003 PROFUSION BONE VOID FILLER KIT BIOGENERATION BERNARD F GRISONI
K031737 06/04/2003 BACT/ALERT MP CULTURE BOTTLES (PLASTIC) BIOMERIEUX, INC. JOCELYN JENNINGS
K031865 06/17/2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE BIOMERIEUX, INC. Nancy Weaver
K031804 06/11/2003 COMPRESS DISTAL FEMORAL REPLACEMENT BIOMET, INC. GARY BAKER
K031734 06/04/2003 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS BIOMET, INC. GARY BAKER
K031693 06/02/2003 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA BIOMET, INC. PATRICIA S BERES
K031881 06/18/2003 AIRBRUSH LIPOSCULPTOR SYSTEM BIOSCULPTURE TECHNOLOGY, INC. ROBERT CUCIN
K031982 06/26/2003 BIRDSONG LEVERHALER, MODEL LH-1000 BIRDSONG MEDICAL DEVICES INC ERIC FUGELSANG
K031801 06/11/2003 PANTOS, MODELS: PANTOS 16, AND PANTOS DG BLUE X IMAGING SRL AL SOSA
K032025 06/30/2003 SENTINOL NITINOL BILLARY STENT SYSTEM BOSTON SCIENTIFIC CORP. TODD KOMMANN
K031844 06/16/2003 VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032008 06/30/2003 VAXCEL WITH PASV PORT, MODEL 45-213 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K031770 06/09/2003 CI TKR/UKR BRAINLAB, AG RAINER BIRKENBACH
K031928 06/23/2003 BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) BRAUN GMBH FRED SCHLADOR
K031773 06/09/2003 ENDO GATOR SYSTEM BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K031749 06/05/2003 BODYGUARD INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K031987 06/27/2003 POWERHEART AED G3, MODEL 9300 CARDIAC SCIENCE KENNETH OLSON
K031840 06/16/2003 CAREMATIX WELLNESS SYSTEM CAREMATIX INC. DANIEL KAMM
K031689 06/02/2003 DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) CHF SOLUTIONS, INC. AMY PETERSON
K031735 06/04/2003 CENTURION SES EPIKERATOME CIBA VISION CORPORATION PENNY NORTHCUTT
K031753 06/05/2003 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031957 06/25/2003 MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031921 06/23/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K031752 06/05/2003 COLTOSOL F COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K031720 06/03/2003 MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. KEITH LOWREY
K031956 06/25/2003 MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. KEITH LOWREY
K031779 06/10/2003 CADSTREAM CONFIRMA, INC. PATRICIA A MILBANK
K031979 06/26/2003 CONMED INTEGRATED SYSTEMS NURSES ASSISTANT CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K031704 06/02/2003 FILMLESS CLINIC CONNECT IMAGING, INC. PHILIP J MANLY
K031850 06/16/2003 DURASIS DURAL SUBSTITUTE COOK BIOTECH, INC. MARK BLEYER
K031766 06/09/2003 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K031966 06/26/2003 ENK FIBEROPTIC ATOMIZER SET COOK, INC. JENNIFER J BOSLEY
K031821 06/13/2003 MODIFICATION TO COOK ZILVER BILIARY STENT COOK, INC. CAROL ZWISSLER
K031802 06/11/2003 CORIX 70 PLUS-USV CORAMEX, S.A. AL SOSA
K031777 06/10/2003 MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K031690 06/02/2003 CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) CYNOSURE, INC. GEORGE CHO
K032014 06/30/2003 N LATEX IGM DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K031825 06/13/2003 C.CAM DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K031849 06/16/2003 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX DATASCOPE CORP. SUSAN E MANDY
K031760 06/06/2003 VIEWPOINT TELEMETRY SYSTEM DATASCOPE CORP. SUSAN E MANDY
K031781 06/10/2003 DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K031910 06/20/2003 STAINLESS STEEL AQUATIC WHEELCHAIR DB PERKS & ASSOCIATES LTD. ED OLIVER
K031706 06/02/2003 CARDIOQ, MODEL 9051-7005 DELTEX MEDICAL LAWERENCE BROOKFIELD
K031793 06/10/2003 DENTATUS OSCIOMAT DENTATUS USA, LTD. RICHARD C LANZILLOTTO
K031932 06/23/2003 FLUORIDE VARNISH DENTSPLY INTL. P. JEFFERY LEHN
K031803 06/11/2003 DEPUY CERAMIC FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K031969 06/26/2003 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DEPUY ORTHOPAEDICS, INC. KATHY K TRIER
K031971 06/26/2003 GLOBAL CAP RESURFACING REPLACEMENT SHOULDER DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K032012 06/30/2003 HOMOCYSTEINE MICROTITER PLATE ASSAY DIAZYME LABORATORIES GREG HOLLAND
K031805 06/11/2003 BLU-U, MODEL 4170 DUSA PHARMACEUTICALS, INC. SCOTT LUNDAHL
K031816 06/12/2003 DVNET MDV-PACS DVNET INTERNATIONAL TECHNOLOGY CO.,LTD. JEN KE-MIN
K031732 06/04/2003 EBI ACUMEN SURGICAL NAVIGATION SYSTEM EBI, L.P. JON CAPAROTTA
K031919 06/23/2003 EBI XFIX DFS SYSTEM EBI, L.P. PETER ALLAN
K031946 06/24/2003 EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE EDWARDS LIFESCIENCES, LLC. JEAN CHANG
K031769 06/09/2003 E-STRIP EEMSO, INC. LARRY R PILOT
K032026 06/30/2003 LCD MONITOR, RADIFORCE G11, G31, G51 EIZO NANAO CORPORATION KAY HAMAGUCHI
K031898 06/19/2003 EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM EKF DIAGNOSTIC GMBH STEPHEN GORSKI
K031999 06/27/2003 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT ELEKTA INSTRUMENT AB PETER LOWENDAHL
K031980 06/26/2003 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB PETER LOWENDAHL
K031778 06/10/2003 PRACTICEBUILDER 1-2-3 ERAD IMAGEMEDICAL CORP. GARY J ALLSEBROOK
K031846 06/16/2003 CARDIOVATIONS OPTICAL BIPOLAR DEVICE ETHICON, INC. PETER CECCHINI
K031847 06/16/2003 CARDIOVATIONS RETRACTOR ETHICON, INC. PETER CECCHINI
K031925 06/23/2003 PROCEED TRILAMINATE SURGICAL MESH ETHICON, INC. REY LIBROJO
K031864 06/16/2003 NITREX NITINOL GUIDEWIRE EV3 CORPORATION CAROLYN ANDERSON
K031841 06/16/2003 SPACER G TEMPORARY HIP PROSTHESIS EXACTECH, INC. GARY J MILLER
K031818 06/12/2003 FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE FACILAI ENTERPRISES LTD. Ke-Min Jen
K031828 06/13/2003 NATURALASE LP ND:YAG LASER FOCUS MEDICAL, LLC. JOHN LEE, JR
K031953 06/25/2003 WEST NILE VIRUS ELISA IGG, MODEL EL0300G FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K031952 06/25/2003 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K031830 06/13/2003 SAFEPRO PLUS SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. JOSEPH J CHANG
K031939 06/23/2003 BIO-EUROLIG INTERFERENCE SCREW FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K031916 06/20/2003 GALT MEDICAL GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K031927 06/23/2003 GE DELTA SOFTWARE OPTION FOR MRI GE MEDICAL SYSTEMS LARRY KREGER
K031871 06/17/2003 AUTOBONE GE MEDICAL SYSTEMS EUROPE LARRY KROGER
K032002 06/27/2003 FERTELL FEMALE FERTILITY TEST GENOSIS, INC. SHARON A SEGAL
K031688 06/02/2003 RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE GUIDANT CORPORATION STEPHANIE ISGRIGG ROBINSON
K031903 06/20/2003 RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 GUIDANT CORPORATION STEPHANIE I ROBINSON
K031811 06/12/2003 PIT & FISSURE SEALANT WITH FLUORIDE HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K031695 06/02/2003 HL168R HEALTH & LIFE CO., LTD. SUSAN CHEN
K031835 06/02/2003 HL888RA HEALTH & LIFE CO., LTD. SUSAN CHEN
K031718 06/03/2003 LIFEVALVE CENTRAL VENOUS CATHTER HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K031702 06/02/2003 REFLEX ANTERIOR CERVICAL PLATE SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K031730 06/04/2003 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS HOWMEDICA OSTEONICS CORP. DEBRA BING
K031941 06/24/2003 HOFFMANN II COMPACT BALTIMORE COUPLING HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031744 06/05/2003 OMNIFIT HFX HIP STEM SERIES HOWMEDICA OSTEONICS CORP. DEBRA BING
K031959 06/25/2003 STRYKER PLATING SYSTEM PERIARTICULAR PLATES HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031729 06/04/2003 TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K031893 06/19/2003 XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K031873 06/17/2003 I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-STAT CORPORATION GREGORY W SHIPP
K031739 06/04/2003 I-STAT CARDIAC TROPONIN (CTNI) TEST I-STAT CORPORATION GREGORY W SHIPP
K031986 06/27/2003 ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS ICS MEDICAL DELMAR F BLOEM
K032020 06/30/2003 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW IIYAMA CORPORATION KAZUYOSHI TATEIWA
K031991 06/27/2003 DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS IMAGE ANALYSIS, INC. BEN ARNOLD
K031885 06/18/2003 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K031897 06/19/2003 PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER IMC-HEARTWAY, LLC JUAN CARLOS RIVERA
K031823 06/13/2003 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 IMPLEX CORP. MARCI HALEVI
K031962 06/25/2003 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS IMPLEX CORP. MARCI HALEVI
K031961 06/25/2003 INION OTPS BIODEGRADABLE MESH PLATING SYSTEM INION LTD. HANNA MARTTILA
K031712 06/02/2003 INION OTPS BIODEGRADABLE PIN INION LTD. HANNA MARTTILA
K031714 06/02/2003 INION TRINION BIODEGRADABLE MENISCUS SCREW INION LTD. HANNA MARTTILA
K031896 06/19/2003 NASAL-AIR CRITICAL CARE INNOMED TECHNOLOGIES FRANK PELC
K031983 06/26/2003 INOVO, INC, ECONOMIZER CONSERVING REGULATOR INOVO, INC. SUSAN D GOLDSTEIN-FALK
K031829 06/13/2003 HEMOSIL FACTOR IX DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K031875 06/17/2003 INTER-OS LIMB LENGTHENER INTER-OS TECHNOLOGIES RANDOLPH C ROBINSON
K031772 06/09/2003 TI FENESTRATED PLATE INTERPORE CROSS INTL. WENDY SPIELBERGER
K031960 06/25/2003 INTRALASE FS LASER INTRALASE CORP. CHARLINE GAUTHIER
K031692 06/02/2003 SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031842 06/16/2003 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031783 06/10/2003 SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 INTRAVASCULAR INCORPORATED STEVE APERAVICH
K031813 06/12/2003 OSSATURA DENTAL ISOTIS NV MARY MCNAMARA-CULLINANE
K031722 06/03/2003 JSA REPROCESSED COMPRESSION SLEEVE DEVICES JACK SPEER AND ASSOC., INC. JACK SPEER
K031895 06/19/2003 KSEA OPSERVER LAP KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K031868 06/17/2003 PROPHYPEARLS KAVO AMERICA DANIEL KAMM
K031750 06/05/2003 SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE KIMBERLY-CLARK CORP. RICHARD V WOLFE
K031728 06/04/2003 KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
K031931 06/23/2003 ECHO SOUNDER EX-101EX 8 MHZ KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K032004 06/30/2003 AQUABOSS ECORO DIA 50 LAUER LTD., HONG KONG STEPHAN KRIETEMEYER
K031797 06/10/2003 METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc. CHENG-I LIN
K031981 06/26/2003 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 LINVATEC BIOMATERIALS, LTD. LAURA KREJCI
K031994 06/27/2003 LINVATEC 300W XENON LIGHT SOURCE LINVATEC CORP. LAURA D KREJCI
K031785 06/10/2003 MACROPORE CARDIO-WRAP (TS) MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K031955 06/25/2003 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K031997 06/27/2003 MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM MALLINCKRODT DAR S.R.L. GIUSEPPE TOMASINI
K031788 06/10/2003 PATHFINDER MASSIE RESEARCH LABORATORIES, INC. N.A. (BERT) MASSIE
K031876 06/17/2003 ELECTRO FLO PERCUSSOR, MODEL 5000 MED SYSTEMS DANIEL KAMM
K031866 06/16/2003 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC MED-TEC,INC. DONALD F RIIBE
K031908 06/20/2003 MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) MED2000 S.R.L. SUSAN D GOLDSTEIN-FALK
K031890 06/18/2003 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031930 06/23/2003 HIGH SPEED EMG MODULE MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K031995 06/27/2003 COMPREHENSIVE NEUROMUSCULAR PROFILER MEDICAL TECHNOLOGIES UNLIMITED, INC. ANGELA MORRIS
K031861 06/16/2003 MIX2VIAL TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. BENNY ARAZY
K031886 06/18/2003 SONOVIEW PRO BY MEDISON CO., LTD. MEDISON CO., LTD. CARL ALLETTO
K031686 06/02/2003 AEROMIST LT, MODEL HCS15004 MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K031933 06/23/2003 MEDLINE REUSABLE SURGICAL GOWNS (100X) MEDLINE INDUSTRIES, INC. STACEY BOLEN-WOLVERTON
K031843 06/16/2003 MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K031808 06/12/2003 MEDRAD SWABBABLE VALVE TRANSFER SET MEDRAD, INC. ANDREW P ZELTWANGER
K031917 06/23/2003 MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S MEDTRONIC MINIMED MIRIELLE MENGOTTO
K032005 06/30/2003 MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 MEDTRONIC MINIMED MIRIELLE MENGOTTO
K031776 06/10/2003 MC2X MULTI-STAGE VENOUS CANNULA MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K031700 06/02/2003 MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K031827 06/13/2003 ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K031782 06/10/2003 GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031833 06/13/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031888 06/18/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K031780 06/10/2003 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031967 06/26/2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K031832 06/13/2003 MEGA PURE CART MEGA SERVICES ROBERT OLIVER
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