FDA 510(k) Decisions During March, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K040229 03/19/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 A & D ENGINEERING, INC. JERRY WANG
K040179 03/03/2004 CONTINUM AALBA DENT, INC. VINCENT M BENETTI
K040180 03/04/2004 CONTINUM V AALBA DENT, INC. VINCENT M BENETTI
K040628 03/25/2004 PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM ABBOTT LABORATORIES GRAHAM BAILLIE
K023060 03/19/2004 ACCULASER PRO4 ACCULASER, INC. PATSY J TRISLER
K033503 03/12/2004 RFS VACUUM GAUGE SCAVENGING CIRCUIT ACCUTRON, INC. ROBERT N CLARK
K040298 03/15/2004 ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K034057 03/09/2004 LACRYTEST ADIATEC SA JOEL LESSER
K033150 03/01/2004 ART POSTERIOR SPINAL SYSTEM ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K040609 03/25/2004 RAPID PROGRAMMER ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K040080 03/31/2004 AESCULAP ABSORBABLE CRANIOFIX AESCULAP, INC. MATTHEW M HULL
K040719 03/26/2004 ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY ALOKA CO., LTD. RICHARD J CEHOVSKY
K033090 03/26/2004 ICON POLYAXIAL PEDICLE SCREW SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K032278 03/05/2004 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE AMBU, INC. SANJAY PARIKH
K040092 03/08/2004 AMEDITECH IMMU TEST DRUG SCREEN PANEL AMEDITECH, INC. JOHN WU
K040538 03/17/2004 BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 AMERICAN MEDICAL SYSTEMS, INC. DENISE THOMPSON
K040521 03/24/2004 MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K040399 03/29/2004 QONTRAST AMID COLLEEN DENSMORE
K040446 03/05/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K032896 03/17/2004 ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02 ANSON MEDICAL LTD. IAN QUIRK
K033531 03/03/2004 POWDERED LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K040618 03/25/2004 LED TURBO APOZA ENTERPRISE CO. LTD. SHIH MIN-TEH
K033200 03/18/2004 ARIOL APPLIED IMAGING CORP. DIANE OATES
K040295 03/12/2004 APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K040260 03/05/2004 INTEGRAL HEMODIALYSIS CATHETER ARROW INT'L. BRANDON EPTING
K040100 03/01/2004 ARROW ECHOGENIC INTRODUCER NEEDLE ARROW INTL., INC. WILLIAM G MCLAIN
K040338 03/01/2004 ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K040159 03/22/2004 APM BLOOD PRESSURE MONITOR, MODEL BP108A ASIA PACIFIC MICROSYSTEMS, INC. KE-MIN JEN
K032840 03/03/2004 ATRION MEDICAL QL INFLATION DEVICE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K034066 03/03/2004 B.BRAUN PREMIXED DIALYSATE B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K040039 03/17/2004 NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K040041 03/29/2004 NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K040040 03/29/2004 NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K040204 03/22/2004 ZYOPTIX XP MICROKERATOME BAUSCH & LOMB, INC. DEBRA L.B. KETCHUM
K040181 03/24/2004 ACCESS DHEA-S REAGENT ASSAY BECKMAN COULTER, INC. MARY BETH TANG
K040099 03/19/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. MONICA E GIGUERE
K040106 03/11/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K032675 03/01/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K033861 03/09/2004 BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. COLLEEN A KISTLER
K040405 03/05/2004 CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K032454 03/04/2004 SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) BIO-LOK INTL., INC. ELAINE DUNCAN
K040277 03/10/2004 LIQUICHEK CARDIAC MARKER CONTROL LT BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K040273 03/04/2004 LYPHOCHEK ASSAYED CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K033792 03/01/2004 BILOK ST SCREW BIOCOMPOSITES LTD. J. STEPHEN BRATT
K032864 03/19/2004 CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 BIOLITEC, INC. JONATHAN S KAHN
K032863 03/19/2004 CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 BIOLITEC, INC. JONATHAN S KAHAN
K040306 03/23/2004 HIGH VOLTAGE PULSED STIMULATOR, MODEL "BMLS02-7" BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K032292 03/22/2004 BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX BIOTEQUE CORP. JENNIFER REICH
K032451 03/17/2004 BIRD TBIRD VELA VENTILATOR BIRD PRODUCTS CORP. TOM GUTIERREZ
K034024 03/19/2004 TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS BISCO, INC. BENJAMIN LICHTENWALNER
K033980 03/03/2004 BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K033702 03/31/2004 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K034068 03/26/2004 CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K040447 03/12/2004 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040492 03/16/2004 VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K040027 03/30/2004 BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM BOSTONSCIENTIFIC CANDICE R BURNS
K033454 03/22/2004 BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN BRAHMS DIAGNOSTICA, LLC. WILLIAM G FRANK
K040203 03/25/2004 MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 BRANAN MEDICAL CORP. RAPHAEL WONG
K033979 03/31/2004 CORLINK AUTOMATED ANASTOMOTIC SYSTEM BY-PASS MAKAFIM LTD. JONATHAN S KAHAN
K033814 03/01/2004 BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 C.R. BARD, INC. SUZANNE LASCALZA
K033389 03/19/2004 POWERPICC CATHETERS, MODELS 3175155, 3175135 C.R. BARD, INC. MICHAELA RIVKOWICH
K033810 03/05/2004 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K031511 03/05/2004 DYNESYS SPINAL SYSTEM CENTERPULSE SPINE-TECH, INC. ANGELA BYLAND
K033919 03/12/2004 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K040534 03/11/2004 VITALAB AMYLASE REAGENT CLINICAL DATA, INC. WYNN STOCKING
K040631 03/18/2004 VITALAB DIRECT BILIRUBIN REAGENT CLINICAL DATA, INC. WYNN STOCKING
K040508 03/08/2004 VITALAB MAGNESIUM REAGENT CLINICAL DATA, INC. WYNN STOCKING
K034000 03/10/2004 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR CLINICAL DATA, INC. WYNN STOCKING
K040467 03/08/2004 VITALAB URIC ACID REAGENT CLINICAL DATA, INC. WYNN STOCKING
K040535 03/29/2004 LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K040455 03/05/2004 LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K033301 03/04/2004 IV ADMINISTRATION AND CONNECT SETS CODAN US CORP. ROHIT PATEL
K033729 03/17/2004 COLLAGEN DENTAL WOUND DRESSINGS COLLAGEN MATRIX, INC. PEGGY HANSEN
K040558 03/17/2004 MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. PEGGY HANSEN
K040551 03/15/2004 COLTOLUX LED CURING LIGHT COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K033594 03/19/2004 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K031304 03/23/2004 SYDNEY IVF PVP COOK UROLOGICAL, INC. BRENDA DAVIS
K040505 03/16/2004 ZILVER 635 BILIARY STENT COOK, INC. LELAND KEYT
K034050 03/22/2004 CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F CORDIS CORPORATION DONNA MARSHALL
K040216 03/26/2004 CERASORB M ORTHO CURASAN AG ERIC WIECHERT
K033518 03/10/2004 LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 CUSTOM PLASTIC PRODUCTS JIM BARLEY
K040156 03/24/2004 IFL PROFESSIONAL SYSTEM, MODEL C100 CYDEN LIMITED MICHAEL NOEL KIERNAN
K033948 03/01/2004 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K040616 03/24/2004 CARDIOMD-AC DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K032803 03/10/2004 DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA DAN KOSEDNAR
K040635 03/30/2004 CARRARA INTERACTION CERAMIC SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K040421 03/18/2004 DUCERAGOLD PORCELAINS DENTSPLY INTL. P. JEFFERY LEHN
K040420 03/18/2004 DUCERAM PLUS CERAMIC SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K033893 03/12/2004 SPECTRUM MODULAR SYSTEM DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
K033901 03/31/2004 MERLIN SPINE SYSTEM DEPUY SPINE,INC JENNIFER MOONEY
K040121 03/17/2004 DERMAWAVE 5000 COMBI MAX SYSTEM DERMAWAVE, LLC ALAN BUNTING
K033921 03/10/2004 AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K033060 03/04/2004 CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K032730 03/26/2004 FIXION HIP SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. HILA WACHSLER-AVRAHAMI
K040053 03/25/2004 PRECISION VPS IMPRESSION MATERIAL DISCUS DENTAL INC. STEVEN L ZIEMBA
K033892 03/09/2004 ULTRAFLEX INFUSION SET DISETRONIC MEDICAL SYSTEMS AG BERND HENNINGSEN
K033876 03/11/2004 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 DOLPHIN MEDICAL INC. BILL CURNAN
K033694 03/22/2004 INFINITY MODULAR MONITORS VF4 MODIFICATIONS DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033807 03/09/2004 INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K030624 03/17/2004 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K034067 03/08/2004 ZTI IMPLANTS SYSTEM, DRM IMPLANTS DRM RESEARCH LABORATORIES, INC. SAMUEL WAKNINE
K040051 03/24/2004 MEGVISION, MODEL EQ1000C SERIES EAGLE TECHNOLOGY, INC. LEWIS FISHER
K032091 03/08/2004 SMART KLAMP VARIOUS BY SIZE EMERGO GROUP, INC. RENE' VAN DE ZANDE
K040596 03/31/2004 ULTRASOUND IMAGING SYSTEM, MODEL 7300 ESAOTE S.P.A. CARRI GRAHAM
K033000 03/22/2004 NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM ESSEX CRYOGENICS OF MISSOURI, INC. ELIZABETH HUNNICUTT
K040286 03/15/2004 ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS ETHOX CORP. EON VERRALL
K040345 03/02/2004 MODIFICATION TO NITREX NITINOL GUIDEWIRE EV3 INC CAROLYN ANDERSON
K040360 03/12/2004 EMU128S, MODEL EX-NW-128S EXCEL TECH. LTD. CAMERON MAHON
K033173 03/24/2004 MICRO TARGETING ELECTRODE FHC, INC. FREDERICK HAER
K040366 03/04/2004 PRESSURE MANIFOLD, MODEL BC 110 FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K033967 03/09/2004 TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P FLIR SYSTEMS PAUL DRYDEN
K040050 03/24/2004 INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN JEFF WAGNER
K040372 03/01/2004 LIGHTSPEED 7.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC JOHN W JAECKLE
K032671 03/17/2004 GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 GEBAUER CO. AMY J PAUKOVITS
K033644 03/24/2004 ENDOBOY GEYSER S.A. FRANCOIS FOURNIER
K040355 03/15/2004 VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K033351 03/11/2004 GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. CARL KNOBLOCH
K040284 03/23/2004 SUSTAIN RADIOLUCENT SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K033645 03/31/2004 OTOFLEX 100 TYE 1012 GN OTOMETRICS A/S PER PAPE THOMSEN
K031903 03/03/2004 RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 GUIDANT CORPORATION STEPHANIE I ROBINSON
K033177 03/11/2004 POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX GUNTER BISSINGER MEDIZINTECHNIK GMBH DAGMAR MASER
K040302 03/09/2004 VERSAPOINT RESECTOSCOPIC SYSTEM GYNECARE, A DIV. OF ETHICON, INC. PATRICIA M HOJNOSKI
K034004 03/03/2004 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE GYRUS ENT L.L.C. ALICIA FARAGE
K034029 03/05/2004 TI CLIP APPLIER GYRX, LLC BRIAN S ZIMOVAN
K033616 03/01/2004 TRAPMATIC SYSTEM SET H.S HOSPITAL SERVICE S.P.A. LUCIO IMPROTA
K040634 03/23/2004 ROBERTSITE VIAL ADAPTER, MODEL 245700021 HALKEY-ROBERTS CORP. JOHN SHELDON
K040547 03/19/2004 AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE HARRY J. BOSWORTH CO. MILDRED GOLDSTEIN
K040548 03/19/2004 AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K023342 03/02/2004 NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG HDC CORP. EARL SMART
K040086 03/10/2004 HEALTH BUDDY WITH BUDDYLINK HEALTH HERO NETWORK, INC. GEOFFREY CLAPP
K034049 03/01/2004 HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K040043 03/03/2004 NDX-40 ALLOY HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K040670 03/25/2004 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K032657 03/24/2004 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K033258 03/09/2004 BONESAVE BONE VOID FILLER HOWMEDICA OSTEONICS LORRAINE MONTEMURRO
K040128 03/26/2004 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS HOWMEDICA OSTEONICS CORP MARGARET F CROWE
K033851 03/02/2004 DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) HYPOGUARD USA, INC. BRUCE MACFARLANE
K040640 03/22/2004 MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL IGC-MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K033619 03/02/2004 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K033783 03/01/2004 IMALUX OCT IMAGING SYSTEM IMALUX COPORATION STEPHANIE A.S. HARRINGTON
K040095 03/05/2004 IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K032860 03/18/2004 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K032850 03/18/2004 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K040077 03/12/2004 IMMUNICON CELLTRACKS AUTOPREP SYSTEM IMMUNICON CORP. PETER J SCOTT
K032386 03/26/2004 UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K034035 03/24/2004 3I PATIENT-SPECIFIC OVERDENTURE BAR IMPLANT INNOVATIONS, INC. JIM BANIC
K033496 03/09/2004 MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE INDUSTRIAL CLOTHINGS, LTD. ALBINA BIANCHI
K033415 03/18/2004 IDI-MRSA INFECTIO DIAGNOSTIC (I.D.I.) INC. CHRISTIAN CHOQUET
K033074 03/31/2004 INION GTR BIODEGRADABLE MEMBRANE SYSTEM INION LTD. HANNA MARTTILA
K031961 03/01/2004 INION OTPS BIODEGRADABLE MESH PLATING SYSTEM INION LTD. HANNA MARTTILA
K033251 03/02/2004 THE FRIENDLYLIGHT ND: YAG LASERS INNOTECH USA, INC. HOWARD M HOLSTEIN
K033136 03/05/2004 I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 INNOVA VISION INC. JENNIFER REICH
K040160 03/08/2004 QUANTA PLEX SLE PROFILE 8 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K040539 03/18/2004 ELLIPTIC MATRIX INSTITUT STRAUMANN AG JOHN KING
K040359 03/19/2004 HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K040205 03/22/2004 INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K040037 03/03/2004 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K040481 03/18/2004 SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031064 03/12/2004 INVACARE POLARIS EX CPAP, MODEL ISP3000 INVACARE CORP. JANICE BROWNLEE
K031176 03/25/2004 INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 INVACARE CORP. RAE ANN FARROW
K040036 03/18/2004 INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905 INVIRO MEDICAL JIM BARLEY
K033208 03/18/2004 IVY DEVICES INC. IV/MEDICAL LINE STABILIZER IVY DEVICES, INC. WILLIAM REILLY
K040065 03/29/2004 JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES JACK SPEER AND ASSOC., INC. JACK SPEER
K040247 03/03/2004 PLUME SAFETY AVF NEEDLE JMS NORTH AMERICA CORP. CHONG SWEE CHEAU
K033846 03/11/2004 KAEN YIH UMBILICAL CORD CLAMP KAEN YIH ENTERPRISE CO., LTD. ANTONIO L GIACCIO
K033555 03/02/2004 KENKOWAVE INFRARED PAIN TREATMENT SYSTEM KAYLIGHT CORPORATION DAVID R BALZER
K033668 03/11/2004 NAVIPRO KNEE SOFTWARE MODULE KINAMED, INC. VINEET K SARIN
K040356 03/01/2004 KOMPRESSOR SCREW SYSTEM KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K040373 03/19/2004 KERATO ANALYZER (EKA) KONAN MEDICAL, INC. GEORGE MYERS
K033970 03/26/2004 CLEARFIL PHOTO CORE PLT KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K040198 03/05/2004 LABONE COCAINE METABOLITE MICRO-PLATE EIA LABONE, INC. LIUMING YU
K040456 03/09/2004 FLEBOSET MULTIPLE LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K034011 03/30/2004 GEMINI SURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K034052 03/15/2004 BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES LATEXX MANUFACTURING SDN.BHD. LAW SIAU WOEI (TERRY LAW)
K032610 03/01/2004 MODIFIED SONAMET BODY COMPOSITION ANALYZER LIFE MEASUREMENT, INC. SHELIA W PICKERING
K040232 03/01/2004 LSI SEW-RIGHT "R" SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 LSI SOLUTIONS CHRISTOPHER A KLACZYK
K040527 03/26/2004 LOW PROFILE LUTHER SAFETY HUBER LUTHER NEEDLESAFE PRODUCTS, INC. GREG HOLLAND
K033998 03/19/2004 MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V MASIMO CORP. JAMES J CRONIN
K033894 03/11/2004 PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 MATSUSHITA ELECTRIC WORKS, LTD. CAROLANN KOTULA
K033880 03/10/2004 ELECTRO-LUBE MECTRA LABS, INC. CHARLES E ALLGOOD JR.
K040325 03/08/2004 PANORET, MODEL PNM 60 MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. DAN LAOR
K032743 03/15/2004 APEX NRG MEDIC NRG LTD. ADI ICKOWICZ
K033986 03/29/2004 MLT-1000 IR LASER SYSTEM MEDICAL LASER THERAPEUTICS LP M. JOYCE HEINRICH
K031930 03/03/2004 HIGH SPEED EMG MODULE MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K031084 03/19/2004 SOLAR GI SYSTEM MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K033774 03/02/2004 CT-MASS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K040517 03/25/2004 TENDERWET ACTIVE MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K033881 03/02/2004 MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE MEDRAD, INC. TROY A JACK
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