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 |
K040173 |
03/19/2004 |
PEDIATRIC AORTIC ROOT CANNULA |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
K032560 |
03/09/2004 |
ARROWHEAD SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K040422 |
03/19/2004 |
MODIFICATION TO VERTE-STACK |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K040583 |
03/31/2004 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K033050 |
03/26/2004 |
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 |
MEDTRONIC VASCULAR |
MAC MCKEEN |
K040568 |
03/25/2004 |
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS |
MEDTRONIC VASCULAR |
Doug Atkins |
K031794 |
03/12/2004 |
ENDOFLEX TRACHEAL TUBE |
MERLYN ASSOCIATES INC. |
CHING CHING SEAH, PH.D. |
K032143 |
03/30/2004 |
LIQUID OXYGEN SYSTEM |
MICRO TECHNOLOGY SERVICES, INC. |
TOMMY BUIE |
K040694 |
03/25/2004 |
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K040002 |
03/22/2004 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 |
MICROLIFE INTELLECTUAL PROPERTY GMB |
SUSAN D GOLDSTEIN-FALK |
K033955 |
03/17/2004 |
RTIST |
MIRADA SOLUTIONS LTD. |
MARIA EBIO |
K032717 |
03/31/2004 |
BIOCRYL RAPIDE INTERFERENCE SCREW |
MITEK WORLDWIDE |
KAREN K SYLVIA |
K040297 |
03/31/2004 |
ONEUSE- PLUS MICROKERATOME |
MORIA S.A. |
MELANIE RENAUD-SAMIRI |
K040348 |
03/09/2004 |
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K040349 |
03/09/2004 |
MODIFICATION TO HRW-127 WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K040288 |
03/05/2004 |
QSC-127-INT SHOULDER ARRAY COIL SET |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K031421 |
03/26/2004 |
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) |
NAKANISHI, INC. |
MASAYUKI ONOGUCHI |
K040486 |
03/11/2004 |
MEDIPACS |
NEOBIT CO., LTD. |
CARL ALLETTO |
K040064 |
03/23/2004 |
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR |
NEWMEDICAL TECHNOLOGY, INC. |
HAITHAM MATLOUB |
K032509 |
03/18/2004 |
MARK 5 NUVO (M5C5) |
NIDEK MEDICAL PRODUCTS, INC. |
JENNIFER MCWILLIAMS |
K034025 |
03/26/2004 |
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC |
NMT MEDICAL, INC. |
ANNE M KULIS |
K031487 |
03/22/2004 |
MODEL AVANT 2120 PULSE OXIMETER AND NIBP |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
K033994 |
03/25/2004 |
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
K040278 |
03/01/2004 |
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
K040473 |
03/10/2004 |
ORAVIVE TOOTH REVITALIZING PASTE |
NOVAMIN TECHNOLOGY, INC. |
DAVID C GREENSPAN |
K040471 |
03/10/2004 |
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
K030920 |
03/10/2004 |
POGS 33 |
ON SITE GAS SYSTEMS, INC. |
FRANCIS X HURSEY |
K034045 |
03/23/2004 |
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 |
ORAL OSTEODISTRACTION, L.P. |
ARTHUR WARD |
K040550 |
03/16/2004 |
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
K040346 |
03/12/2004 |
MODIFICATION TO ORIA TOP CLIP SYSTEM |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
K021569 |
03/15/2004 |
RESTFUL NIGHTS, IST-APPLIANCE |
OTTAWA DENTAL LABORATORY |
E.J. Smith |
K033249 |
03/05/2004 |
PAJUNK MODULAR HANDLE INSTRUMENTS |
PAJUNK GMBH |
LYNETTE L HOWARD |
K033549 |
03/10/2004 |
STARLUX PULSED LIGHT SYSTEM |
PALOMAR MEDICAL PRODUCTS, INC. |
Marcy Moore |
K040357 |
03/03/2004 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
K040304 |
03/01/2004 |
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
K033920 |
03/17/2004 |
CAAS II RVA |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
K032086 |
03/19/2004 |
KRYO ART CONTROLLED RATE FREEZER |
PLANER PLC |
DAVID S SCHLERF |
K033080 |
03/10/2004 |
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER |
PORTEX, INC. |
CINDY ENGELHARDT |
K040398 |
03/24/2004 |
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K033933 |
03/16/2004 |
POWERLITE 600 EX SYSTEM |
PRESWEDE AB |
SUSAN D GOLDSTEIN-FALK |
K032445 |
03/29/2004 |
THE ULTRA SYSTEM |
PROMEDICA, INC. |
RICHARD BLOOM |
K034048 |
03/10/2004 |
R&D GLU-LINE HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
K033460 |
03/26/2004 |
CHEETAH WHEELCHAIR |
R82 A/S |
KIRK MACKENZIE |
K033291 |
03/17/2004 |
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 |
RADI MEDICAL SYSTEMS AB |
HELENE EKSTRAND |
K040351 |
03/12/2004 |
RANDOX LIQUID CRP CONTROLS |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K031114 |
03/03/2004 |
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
K033410 |
03/05/2004 |
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
K030797 |
03/10/2004 |
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM |
RESMED CORP. |
DAVID D'CRUZ |
K033841 |
03/10/2004 |
RESMED S8 PRIME CPAP SYSTEM |
RESMED LTD. |
DAVID D'CRUZ |
K034032 |
03/16/2004 |
PLV CONTINUUM VENTILATOR, MODEL P2000 |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
K040595 |
03/18/2004 |
ALICE 5 |
RESPIRONICS, INC. |
ZITA A YURKO |
K032834 |
03/04/2004 |
BIPAP PRO 2 BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
K040453 |
03/11/2004 |
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 |
REVIVANT CORP. |
BOB H KATZ |
K040586 |
03/22/2004 |
MESACUP TEST MPO, MODEL 11053 |
RHIGENE, INC. |
NANCI DEXTER |
K040200 |
03/04/2004 |
MESACUP-2 TEST CENP-B |
RHIGENE, INC. |
YUSUKE KOBE |
K034046 |
03/10/2004 |
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 |
RNK PRODUCTS |
CHARLES R ABBRUSCATO |
K040245 |
03/24/2004 |
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K040280 |
03/11/2004 |
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K040435 |
03/10/2004 |
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K040434 |
03/10/2004 |
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K040431 |
03/10/2004 |
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K023525 |
03/26/2004 |
RETISCAN, RETIPORT |
ROLAND CONSULT |
MATTHIAS MAI |
K040448 |
03/23/2004 |
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM |
ROSNER-MAUTBY MEDITRADE(THAILAND) LTD. |
HO WENG FATT |
K033764 |
03/01/2004 |
SP NEWTRON MODULE |
SATELEC |
PASCAL DUPEYRON |
K033109 |
03/23/2004 |
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS |
SCIENT'X |
J.D. WEBB |
K032986 |
03/01/2004 |
CLO-SURPLUSP.A.D. |
SCION CARDIO-VASCULAR, INC. |
RAMON AUGUSTO PAZ |
K032459 |
03/09/2004 |
PROFILE 1320 LASER SYSTEM |
SCITON, INC. |
JAY M PATEL |
K040005 |
03/29/2004 |
PROFILE 2000/3000 LASER SYSTEM |
SCITON, INC. |
JAY M PATEL |
K040130 |
03/26/2004 |
ANTERIOR LUMBAR BUTTRESS SYSTEM |
SEASPINE |
DIANA SMITH |
K034059 |
03/09/2004 |
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE |
SECTRA AB |
CARL ALLETTO |
K032516 |
03/04/2004 |
HIOX80 AEROSOL ADAPTER |
SENSORMEDICS CORP. |
PAUL L KITTINGER |
K033762 |
03/15/2004 |
SERRALAPG |
SERRAL, S.A. DE C.V. |
SCOTT HENDERSON |
K031142 |
03/17/2004 |
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
K040561 |
03/31/2004 |
MANUAL WHEELCHAIR SERIES |
SHANGHAI WHEELCHAIR FACTORY |
TRACY MA |
K032733 |
03/03/2004 |
PM-8000 PATIENT MONITOR, MODEL 8000 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K040408 |
03/17/2004 |
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) |
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
JANNA P TUCKER |
K024213 |
03/23/2004 |
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
K040502 |
03/09/2004 |
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
K040347 |
03/09/2004 |
SIREMOBIL ISO-C 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
NEALIE HARTMAN |
K040577 |
03/22/2004 |
SOMATOM PROJECT P30L |
SIEMENS MEDICAL SYSTEMS, INC. |
NEALIE HARTMAN |
K032688 |
03/05/2004 |
COLONOSIGHT MODEL 510B |
SIGHTLINE TECHNOLOGIES LTD. |
SHARON GOLDFARB-ALBAK |
K040320 |
03/12/2004 |
SINON POWER WHEELCHAIR, SN-P401 |
SINON CORPORATION |
JEN KE-MIN |
K034012 |
03/16/2004 |
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
K040462 |
03/23/2004 |
TRIGEN TROCHANTERIC ANTEGRADE NAIL |
SMITH & NEPHEW, INC. |
KIM KELLY |
K033191 |
03/09/2004 |
SOHNIKS |
SOHNIKS ENDOSCOPY, INC. |
MARC HOSKINS |
K040162 |
03/16/2004 |
CORRESTORE PATCH SYSTEM |
SOMANETICS CORP. |
RONALD A WIDMAN |
K033947 |
03/04/2004 |
SHIRAZ POSTERIOR SYSTEM |
SPINE NEXT AMERICA |
DIANE JOHNSON |
K033965 |
03/04/2004 |
SHIRAZ-ANTERIOR SYSTEM |
SPINE NEXT AMERICA |
DIANE JOHNSON |
K032227 |
03/29/2004 |
DUREX FLAVORED LATEX CONDOM |
SSL AMERICAS, INC. |
KATHLEEN HARRIS |
K040353 |
03/11/2004 |
FLIGHT SOCK |
SSL AMERICAS, INC. |
KATHLEEN J HARRIS |
K032932 |
03/10/2004 |
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR |
STANBIO LABORATORY |
ADAOBI OGUCHI |
K032936 |
03/12/2004 |
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR |
STANBIO LABORATORY |
ADAOBI OGUCHI |
K032816 |
03/26/2004 |
QUANTUM LIGHT THERAPY SYSTEM |
STARGATE INTERNATIONAL, INC. |
ROBERT H WALKER |
K033944 |
03/12/2004 |
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD |
STELKAST COMPANY |
DONALD A STEVENS |
K040025 |
03/02/2004 |
A1C-CELLULAR |
STRECK LABORATORIES, INC. |
KERRIE OETTER |
K040300 |
03/03/2004 |
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
K040022 |
03/12/2004 |
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
K033236 |
03/26/2004 |
PRIZM KERATOME BLADE, MODEL MK8512M2 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HAAR |
K040119 |
03/17/2004 |
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION |
SYNOVIS SURGICAL INNOVATIONS |
ANGELA MALLERY |
K040001 |
03/09/2004 |
STEERABLE STYLET |
SYNOVIS SURGICAL INNOVATIONS |
JAMES JENKINS |
K033995 |
03/01/2004 |
3.5 MM LCP DISTAL HUMERUS SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
K033816 |
03/02/2004 |
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
K033975 |
03/01/2004 |
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS |
SYNTHES (USA) |
LISA M BOYLE |
K040083 |
03/31/2004 |
SYNTHES EXTERNAL MIDFACE DISTRACTOR |
SYNTHES (USA) |
LISA M BOYLE |
K040258 |
03/23/2004 |
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE |
SYNTHES (USA) |
ANGELA SILVESTRI |
K031100 |
03/04/2004 |
SYNTHES VENTROFIX MIS SYSTEM |
SYNTHES (USA) |
JOHN WALSH |
K040073 |
03/18/2004 |
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
K040507 |
03/04/2004 |
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H |
TAGA MEDICAL TECHNOLOGIES, INC. |
GARY AUSTIN |
K040472 |
03/15/2004 |
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE |
TELEFLEX MEDICAL |
ANGELA TRAN |
K040023 |
03/01/2004 |
CAPIOX FLEXIBLE VENOUS RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K040210 |
03/03/2004 |
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR |
TERUMO CORP. |
GARRY A COURTNEY |
K033913 |
03/11/2004 |
PROGREAT |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K040531 |
03/23/2004 |
TERUMO SURGUARD2 SAFETY NEEDLE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
K040076 |
03/15/2004 |
ANSPACH ADVANCED MICRO SAW ATTACHMENTS |
THE ANSPACH EFFORT, INC. |
WILLIAM G CONETY |
K040009 |
03/11/2004 |
FREELITE HUMAN KAPPA AND LAMBDA KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
K040244 |
03/24/2004 |
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 |
THE MICROOPTICAL CORPORATION |
DANIEL J DILLON |
K040291 |
03/11/2004 |
EL-ANA PROFILES: ANTI-CHROMATIN |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
K040134 |
03/09/2004 |
THERILINK BONE VOID FILLER |
THERICS, INC. |
JOHNATHAN S KAHAN |
K032330 |
03/02/2004 |
CT OIA |
THERMO BIOSTAR, INC. |
JOHN G ADAMS |
K034014 |
03/05/2004 |
SPI CONTACT DENTAL IMPLANT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
K033923 |
03/17/2004 |
TH0R DDII IR LAMP SYSTEM |
THOR INTL. |
M. JOYCE HEINRICH |
K031935 |
03/03/2004 |
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
K040110 |
03/24/2004 |
EASY LOOP, MODEL EZL-01 |
TOOLS FOR SURGERY, LLC |
ARNOLD R LEIBOFF |
K040109 |
03/25/2004 |
HEMORRHAGE OCCLUDER PIN |
TOOLS FOR SURGERY, LLC |
ARNOLD R LEIBOFF |
K040112 |
03/12/2004 |
TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE |
TRI-MED, INC. |
ROBERT J MEDOFF |
K040250 |
03/23/2004 |
BONE-LOK HP WASHER |
TRIAGE MEDICAL INC |
GAYLE HIROTA |
K033149 |
03/23/2004 |
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM |
ULTIMATE CONCEPTS, INC. |
GRACE HOLLAND |
K040370 |
03/11/2004 |
WBR-FHR, WBR-FWB |
ULTRASPECT LTD. |
DAN LAOR |
K040341 |
03/08/2004 |
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
K040329 |
03/08/2004 |
MODIFICATION TO E.P.T. PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
K040594 |
03/31/2004 |
HERCULON SOFT TISSUE REATTACHMENT SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K033954 |
03/19/2004 |
SHAPE LOCKING ENDOSCOPIC OVERTUBE |
USGI MEDICAL, INC. |
JEFFREY A ANDERSON |
K040541 |
03/22/2004 |
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K040510 |
03/17/2004 |
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
GREGORY M SACHS |
K033617 |
03/01/2004 |
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY |
VASOMEDICAL, INC. |
THOMAS R VARRICCHIONE |
K033842 |
03/04/2004 |
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE |
VERNON-CARUS LIMITED |
C. ROBERT PAYNE, JR., P.E. |
K040003 |
03/26/2004 |
VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
BRUCE KHALILI |
K032885 |
03/10/2004 |
VIDAPORT INTRAOSSEOUS INFUSION SYSTEM |
VIDACARE CORPORATION |
GREG HOLLAND |
K023684 |
03/01/2004 |
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 |
VILEX, INC. |
ABRAHAM LAVI |
K040279 |
03/02/2004 |
VIVARING MICROWAVE ABLATION PROBE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
K040226 |
03/25/2004 |
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K033378 |
03/01/2004 |
VITAL SIGNS MONITOR, PROPAQ LT |
WELCH ALLYN PROTOCOL, INC. |
DAVE KLEMENTOWSKI |
K033870 |
03/12/2004 |
IMAGE MANAGEMENT SYSTEM |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
K040436 |
03/05/2004 |
SIMIDUR SUPERIOR |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K040691 |
03/23/2004 |
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D |
WIN-US TECHNOLOGY CO., LTD. |
JAY MANSOUR |
K020895 |
03/05/2004 |
ALLOMATRIX MODEL# 86 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROGER D BROWN |
K034028 |
03/11/2004 |
ATH FEMORAL STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
K040503 |
03/16/2004 |
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
K033887 |
03/02/2004 |
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
K033297 |
03/18/2004 |
ZAP HCG TEST, MODEL 8001 |
ZBX CORPORATION |
TRACY YANG |
K033977 |
03/22/2004 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
K040532 |
03/23/2004 |
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) |
ZI BO HONG WANG PLASTIC & RUBBER PRODUCTS CO. LTD. |
HUAN-CHUNG LI |