FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K040890 |
11/02/2004 |
3M TEGADERM SILVER |
3M COMPANY |
AMY E SHORT |
K043097 |
11/19/2004 |
3VISEON |
3MENSIO MEDICAL IMAGING BV |
CARL ALLETTO |
K042390 |
11/19/2004 |
ETEST FOR GEMIFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
K040115 |
01/30/2004 |
PICCOLO MAGNESIUM TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
K040114 |
01/29/2004 |
ABBOTT DATA PORT PC, MODEL 12181 |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
K033845 |
01/08/2004 |
PRECISION XCEED DIABETES MONITORING SYSTEM |
ABBOTT LABORATORIES |
TRACEY H WIELINSKI |
K032051 |
01/09/2004 |
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P |
ACCESS BATTERY, INC. |
ALEXANDER B HENDERSON |
K042752 |
11/10/2004 |
ACCUPACH V |
ACCUTOME ULTRASOUND, INC. |
JEFFREY L WRIGHT |
K042069 |
11/01/2004 |
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
K033639 |
01/15/2004 |
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
K042880 |
11/03/2004 |
JETSTREAM WORKSPACE |
ADAC LABORATORIES |
COLEEN A COLEMAN |
K042496 |
11/02/2004 |
ADEPT ULTRALITE 532 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
DEN040001 |
01/21/2004 |
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM |
ADVANCED DIAGNOSTIC SYSTEMS |
DEBRA J RASMUSSEN |
K033757 |
01/30/2004 |
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
K041855 |
11/10/2004 |
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S |
AEARO CO. |
ANN PHILLIPS |
K032108 |
01/15/2004 |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) |
AESCULAP, INC. |
JOYCE KILROY |
K042227 |
11/19/2004 |
INSTANT-VIEW TROPONIN I TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K041978 |
11/23/2004 |
REPROCESSED DIAMOND BURS |
ALLIANCE MEDICAL CORP. |
ERIC VARTY |
K033423 |
01/15/2004 |
REVOLIX LASER SYSTEMS |
ALLMED SYSTEMS INC. |
PETER ALLEN |
K033437 |
01/20/2004 |
SPHINX LASER SYSTEMS |
ALLMED SYSTEMS INC. |
PETER ALLEN |
K040015 |
01/21/2004 |
MODIFICATION TO PRISMALIX SURGICAL LIGHT |
ALM S.A. |
FREDERICK R CATT |
K043196 |
11/30/2004 |
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
K042250 |
11/12/2004 |
SENSATOUCH |
ALUNA MANAGEMENT CO., LTD. |
CHARITY MARTIN |
K042843 |
11/12/2004 |
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS |
AMBU, INC. |
SANJAY PARIKH |
K042682 |
11/15/2004 |
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR |
AMBU, INC. |
SANJAY PARIKH |
K041712 |
11/03/2004 |
'RAPIDTEC 4' TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K032003 |
01/07/2004 |
PREMIER PLUS |
AMERICAN IMEX |
ALEX FONG |
K030275 |
11/29/2004 |
MB SYSTEM, BIOENERGY LIGHT THERAPY |
AMEST CORP. |
JOHN IEST |
K042889 |
11/16/2004 |
DYNAMOMETER - MODEL FCE AND MODEL MSC |
AMETEK |
PHILIP LACHANCE |
K042906 |
11/19/2004 |
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 |
AMPLIFE CORPORATION |
SUSAN D GOLDSTEIN-FALK |
K043025 |
11/19/2004 |
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 |
ANALOGIC CORP. |
DONALD J SHERRATT |
K042685 |
11/18/2004 |
METRICATH SYSTEM |
ANGIOMETRX INC. |
TIM VERSPAGEN |
K032710 |
01/09/2004 |
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT |
APOGEE MEDICAL, INC. |
DIANE N PEPER |
K041766 |
11/26/2004 |
EZY-TRAVEL WRISTBAND |
APOTHECARY PRODUCTS, INC. |
DAVID KRAMER |
K031715 |
01/08/2004 |
ARIOL HER-2/NEU IHC |
APPLIED IMAGING CORP. |
DIANE C OATES |
K042443 |
11/24/2004 |
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL |
ARKRAY, INC. |
HELEN LANDICHO |
K041427 |
11/24/2004 |
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
K032245 |
01/14/2004 |
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 |
ARTHREX, INC. |
ANN WATERHOUSE |
K041356 |
11/04/2004 |
ARTHREX TENODESIS SCREW FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
K041189 |
11/04/2004 |
ARTHREX TRIMIT FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
K032822 |
01/08/2004 |
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 |
ASAP ENDOSCOPIC PRODUCTS GMBH |
MARTINA GUENDEROTH |
K042690 |
11/13/2004 |
ASCENSION PYROSPHERE (PCS) |
ASCENSION ORTHOPEDICS, INC. |
PETER STRZEPA |
K042968 |
11/24/2004 |
MCL 30 DERMABLATE ER:YAG LASER SYSTEM |
ASCLEPION LASER TECHNOLOGIES GMBH |
GEORGE CHO |
K033532 |
01/28/2004 |
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES |
ASIA PACIFIC LATEX SDN BHD |
LEE SON HONG |
K033530 |
01/28/2004 |
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES |
ASIA PACIFIC LATEX SDN BHD |
LEE SON HONG |
K030267 |
01/15/2004 |
EEG MONITOR WITH BIS, MODEL A-2000 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
K043138 |
11/22/2004 |
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 |
ATOS MEDICAL AB |
EDDY ABERG |
K030655 |
01/29/2004 |
HOLOTC RIA |
AXIS-SHIELD BIOCHEMICALS, ASA |
RONALD G LEONARDI |
K033606 |
01/30/2004 |
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST |
AXIS-SHIELD DIAGNOSTICS, LTD. |
JUDITH FINLAYSON, PH.D. |
K042580 |
11/17/2004 |
TIDI BRAND STERILIZATION WRAP |
BANTA HEALTHCARE GROUP, LTD. |
INA GORDON |
K042942 |
11/22/2004 |
MGP 15 DICOM THEATER |
BARCO NV BARCOVIEW |
FRANK FURGUSON |
K042660 |
11/19/2004 |
NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
K042661 |
11/19/2004 |
NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FURGUSON |
K042662 |
11/22/2004 |
NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
K041172 |
11/18/2004 |
BASBA E-MACHINE |
BASBA INC. |
M. JOYCE HEINRICH |
K040985 |
11/30/2004 |
PUMP CONNECTIVITY INTERFACE |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
K042936 |
11/26/2004 |
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
K033643 |
01/08/2004 |
CO2 CALIBRATOR/DILUENT |
BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
KENNETH T EDDS, PH.D. |
K042459 |
11/17/2004 |
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT |
BECKMAN COULTER, INC. |
KIM WALKER |
K042291 |
11/12/2004 |
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K042812 |
11/22/2004 |
BBLCHROMAGAR MRSA |
BECTON DICKINSON & CO. |
DENNIS R MERTZ |
K033500 |
01/29/2004 |
BD CAREFLOW CENTRAL VENOUS CATHETER |
BECTON DICKINSON & CO. |
LESLIE WOOD |
K042491 |
11/22/2004 |
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER |
BECTON DICKINSON & CO. |
LESLIE WOOD |
K033560 |
01/14/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS |
BECTON DICKINSON & CO. |
KATHRYN BABKA POWERS |
K033557 |
01/14/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
K033279 |
01/15/2004 |
GOLD DENTAL CASTING ALLOYS |
BEGO U.S.A. |
WILLIAM OREMUS |
K042400 |
11/24/2004 |
MUCOTROL CONCENTRATED ORAL GEL WAFER |
BELCHER PHARMACEUTICALS, INC. |
KOTHA SEKHARAM |
K042586 |
11/03/2004 |
BEST BREAST BRACHYTHERAPY APPLICATOR |
BEST MEDICAL INTERNATIONAL, INC. |
JOSEPH C WANG |
K042786 |
11/18/2004 |
BEST MODEL # 81-01 SERIES IR-192 SOURCES |
BEST MEDICAL INTERNATIONAL, INC. |
JOSEPH C WANG |
K031568 |
11/23/2004 |
BICONITE SURFACE TREATMENT |
BICON, INC. |
VINCENT J MORGAN |
K042637 |
11/15/2004 |
THE 5.0 X 6.0MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
K042837 |
11/02/2004 |
LIQUICHEK ELEVATED CRP CONTROL |
BIO-RAD |
ELIZABETH PLATT |
K042836 |
11/05/2004 |
LIQUICHEK RETICULOCYTE CONTROL (A) |
BIO-RAD |
ELIZABETH PLATT |
K042865 |
11/24/2004 |
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) |
BIO-RAD |
SUZANNE S PARSONS |
K042815 |
11/05/2004 |
QUEST TUMOR MARKER CONTROL, MODEL 955 |
BIO-RAD |
ELIZABETH PLATT |
K042446 |
11/02/2004 |
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS |
BIO-RAD LABORATORIES, INC. |
MARIA ZEBALLOS |
K033155 |
01/12/2004 |
BIOCENTREX CARDIAC PANEL |
BIOCENTREX |
THOMAS H GROVE |
K042231 |
11/12/2004 |
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
JOHN GREENBAUM |
K041432 |
11/30/2004 |
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT |
BIOFILM, INC. |
ROBERT L DE ARMOND |
K042314 |
11/22/2004 |
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE |
BIOGEN |
VICTOR J GANGI |
K030523 |
01/30/2004 |
WATERLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K041388 |
11/23/2004 |
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 |
BIOMEDICAL LIFE SYSTEMS, INC. |
GARY BUSSETT |
K033455 |
01/15/2004 |
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 |
BIOMEDICAL LIFE SYSTEMS, INC. |
DONNA HERATY |
K042093 |
11/01/2004 |
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS |
BIOMET, INC. |
TAACY BICKEL JOHNSON |
K042029 |
11/09/2004 |
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K041595 |
11/12/2004 |
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 |
BIOPRO, INC. |
DAVID MARK |
K032235 |
01/28/2004 |
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
K042890 |
11/29/2004 |
TRIAGE D-DIMER TEST, MODEL 98100 |
BIOSITE INCORPORATED |
JEFFERY R DAHLEN |
K042083 |
11/16/2004 |
MODIFICATION TO VISITOME 20-10 MICROKERATOME |
BIOVISION AG |
DALE SADLIK |
K033521 |
01/16/2004 |
BISBLOCK |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
K033585 |
01/16/2004 |
DIAPEX |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
K033472 |
01/15/2004 |
TESCERA U-BAR AND BARRELS |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
K042134 |
11/01/2004 |
VERSATILE 1 WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
RICHARD WESTON |
K033742 |
01/12/2004 |
BOSTON SCIENTIFIC V-18 CONTROL WIRE |
BOSTON SCIENTIFIC CORP. |
DEBORAH THOMAS |
K042882 |
11/09/2004 |
ENTERYX INJECTION CATHETER |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
K040018 |
01/20/2004 |
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 |
BOSTON SCIENTIFIC CORP. |
JAMES D MCMAHON |
K034061 |
01/30/2004 |
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH |
BOSTON SCIENTIFIC CORP. |
CHRISTINA L ROWE |
K041818 |
11/10/2004 |
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
K032214 |
01/29/2004 |
MEDONIC CA620/530 HEMATOLOGY ANALYZER |
BOULE MEDICAL AB |
ANDREW SWANSON |
K032511 |
01/21/2004 |
INTUITION IMAGE |
BRAINLAB, AG |
RAINER BIRKENBACH |
K041464 |
11/05/2004 |
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
K033936 |
01/14/2004 |
BARD ELIMINATOR PET BALLOON DILATORS |
C.R. BARD, INC. |
MICHAEL A PATZ |
K034020 |
01/21/2004 |
GROSHONG NXT PICC CATHETERS |
C.R. BARD, INC. |
PEGGY KEIFFER |
K034065 |
01/15/2004 |
MODIFICATION TO X-PORT DUO PORT |
C.R. BARD, INC. |
ANGELA BRADY |
K042949 |
11/09/2004 |
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) |
C.R. BARD, INC. |
JOHN C KNORPP |
K034019 |
01/21/2004 |
POLY PER-Q-CATH PICC CATHETERS |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
K041088 |
11/01/2004 |
TRIFUSION, MODEL 0609190/0659350 |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K042350 |
11/03/2004 |
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
K033331 |
01/16/2004 |
CANDELA CBEAM PULSE DYE LASER SYSTEM |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
K041242 |
11/22/2004 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
K033461 |
01/16/2004 |
CANDELA VBEAM PULSE DYE LASER SYSTEM |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
K041392 |
11/08/2004 |
SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US |
CAO GROUP, INC. |
ROBERT K LARSEN |
K042615 |
11/05/2004 |
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
K043096 |
11/24/2004 |
COMMANDER II |
CARDIOCOM |
CONSTANCE G BUNDY |
K042806 |
11/24/2004 |
QUADRANT UNIT-1-BOND |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K033514 |
01/06/2004 |
CODA CX1 MOTION ANALYSIS SYSTEM |
CHARNWOOD DYNAMICS LTD. |
DAVID L MITCHELSON |
K042144 |
11/12/2004 |
NICOM |
CHEETAH MEDICAL INC. |
BENNY ARAZY |
K042176 |
11/03/2004 |
AQUIFY LENS COMFORT DROPS |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
K042039 |
11/17/2004 |
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
K033910 |
01/30/2004 |
OLYMPUS URINE CALIBRATOR |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K032604 |
01/20/2004 |
GII SPINAL FIXATION SYSTEM |
CO-LIGNE AG |
ARIEL DUJOVNE, ING. M.SC. |
K042796 |
11/05/2004 |
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE |
COAPT SYSTEMS, INC. |
BANKIM MEHTA |
K042473 |
11/19/2004 |
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM |
COBE CARDIOVASCULAR, INC. |
JACK ELLISON |
K033760 |
01/23/2004 |
ONE COAT SE BOND |
COLTENE/WHALEDENT INC. |
HENRY J VOGELSTEIN |
K042746 |
11/22/2004 |
PET-DOSE |
COMECER S.R.L. |
E.J. Smith |
K031621 |
01/22/2004 |
HERO 1, MODEL LY-ESB220 |
COMFORT ORTHOPEDIC CO. LTD. |
ERIC H.C. LEE |
K033515 |
01/22/2004 |
HUBERPRO SAFETY HUBER INFUSION SET |
COMMAND MEDICAL PRODUCTS |
JOYCE VYTLACIL |
K033344 |
01/16/2004 |
LIGAND PLUS CONTROL LEVEL 1-3 |
CONSOLIDATED TECHNOLOGY |
CANDICE BETZ |
K033903 |
01/16/2004 |
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
K033904 |
01/16/2004 |
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
K042611 |
11/12/2004 |
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE |
COOK, INC. |
EARL KNIGHT |
K042824 |
11/16/2004 |
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
BONNIE J TSYMBAL |
K042969 |
11/08/2004 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
DONNA MARSHALL |
K034013 |
01/08/2004 |
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 |
CORGENIX, INC. |
NANCI DEXTER |
K042680 |
11/19/2004 |
RHIGENE HEP-ANA TEST SYSTEM |
CORGENIX, INC. |
YUSUKE KOBE |
K034062 |
01/30/2004 |
CP SLEEVE AND RIVER SLEEVE |
CP MEDICAL |
MARY ANN GREENAWALT |
K042230 |
11/05/2004 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
KIM TOMPKINS |
K030876 |
01/22/2004 |
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM |
CYNOSURE, INC. |
GEORGE CHO |
K033176 |
01/21/2004 |
TRISTAR AESTHETIC WORKSTATION LASER |
CYNOSURE, INC. |
GEORGE CHO |
K041080 |
11/30/2004 |
SURGICAL DRAPE KIT - D.I.R.R.A. SRL |
D.I.R.R.A. S.R.L. |
ELISABETTA BACCHI |
K033525 |
01/12/2004 |
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K042347 |
11/19/2004 |
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K033908 |
01/22/2004 |
N HIGH SENSITIVITY CRP |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
K032692 |
01/22/2004 |
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 |
DAKO A/S |
GITTE BRINKMANN |
K033865 |
01/21/2004 |
IDEIA PCE CHLAMYDIA |
DAKOCYTOMATION LTD |
JENNIE OATES |
K033215 |
01/09/2004 |
PREPAIR |
DANVILLE MATERIALS, INC. |
CRAIG R BRUNS |
K024252 |
01/22/2004 |
MATCH MASTER LOW FUSION PORCELAIN |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
K041680 |
11/10/2004 |
ORAJEL ADVANCED TOOTH DESENSITIZER |
DEL PHARMACEUTICALS, INC. |
MARLENE TIETJEN |
K042196 |
11/01/2004 |
SAVEDENT BLUE |
DENFOTEX LIGHT SYSTEMS LTD |
JOHN COLLES |
K042153 |
11/08/2004 |
SOUTH BEACH SMILE LIGHT WHITENING SYSTEM |
DENTOVATIONS, INC. |
M. JOYCE HEINRICH |
K033667 |
01/23/2004 |
CARRARA PRESS SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K032361 |
01/12/2004 |
ENDOPURE ROOT CANAL CLEANSER |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K042905 |
11/04/2004 |
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY |
DENTSPLY INTL. |
HELEN LEWIS |
K041075 |
11/09/2004 |
FASTIN RC ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KAREN SYLVIA |
K041069 |
11/09/2004 |
SPIRALOK ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KAREN SYLVIA |
K033338 |
01/08/2004 |
PINNACLE REVISION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
BOB FRIDDLE |
K042544 |
11/23/2004 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K041928 |
11/23/2004 |
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K041926 |
11/23/2004 |
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K041927 |
11/23/2004 |
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K034055 |
01/21/2004 |
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE, PH.D. |
K034022 |
01/30/2004 |
UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES |
DIAMODENT |
JEFF RASSOLI |
K033056 |
01/30/2004 |
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
K033058 |
01/30/2004 |
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
K033055 |
01/30/2004 |
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS |
DIAMOND DIAGNOSTICS, INC. |
LINDA STUNDTNER |
K033323 |
01/13/2004 |
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING |
DIDECO S.P.A. |
BARRY SALL |
K033987 |
01/08/2004 |
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS |
DIDECO S.P.A. |
BARRY SALL |
K034037 |
01/28/2004 |
SKY BONE EXPANDER SYSTEM |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHN |
K033381 |
01/27/2004 |
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL |
DISCUS DENTAL INC. |
STEVEN L ZIEMBA |
K033227 |
01/16/2004 |
LUXAFORM PLUS |
DMG USA, INC. |
PAMELA PAPINEAU |
K042607 |
11/26/2004 |
PRIMUS US |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
K033312 |
01/13/2004 |
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K042197 |
11/15/2004 |
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
K042704 |
11/26/2004 |
REUSABLE FINGER CLIP SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K031367 |
01/23/2004 |
DUOPATH VEROTOXINS GLISA TEST |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
K040354 |
11/04/2004 |
METAL/METAL HIP SYSTEM |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
K042918 |
11/22/2004 |
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 |
ENDO OPTIKS, INC. |
KEITH HERTZ |
K041708 |
11/30/2004 |
ENPATH SAFETY INTRODUCER |
ENPATH MEDICAL INCORPORATED |
KARYL HASKELL |
K042700 |
11/08/2004 |
IMAGE MEDICAL ACQUISITION STATION (IMAS) |
ERAD IMAGEMEDICAL CORP. |
GARY J ALLSEBROOK |
K033590 |
01/30/2004 |
ERBE HELIX HYDRO-JET |
ERBE USA, INC. |
JOHN TARTAL |
K032199 |
01/30/2004 |
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT |
ESA, INC. |
HAROLD ASP |
K042897 |
11/19/2004 |
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
K042753 |
11/08/2004 |
MAMMOTOME MR BIOPSY SYSTEM |
ETHICON ENDO-SURGERY, INC. |
CAROL J SPRINKLE |
K031147 |
01/12/2004 |
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY SHOEMAKER |
K030341 |
01/16/2004 |
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM |
EVENT MEDICAL LTD |
ROBBIE WALSH |
K042842 |
11/09/2004 |
NOVATION 12/14 PRESS-FIT FEMORAL STEM |
EXACTECH, INC. |
Lisa Simpson |
K031841 |
01/22/2004 |
SPACER G TEMPORARY HIP PROSTHESIS |
EXACTECH, INC. |
GARY J MILLER |
K041869 |
11/18/2004 |
SELF RETAINING BICANALICULUS INTUBATION SET |
FCI OPHTHALMICS, INC. |
LOUIS ARMAND |
K041470 |
11/22/2004 |
MORTON IUI CATHETERS |
FERTILITY TECHNOLOGY RESOURCES, INC. |
CONSTANCE W STURGEON |
K033087 |
01/14/2004 |
ORACLE ORAL MASK, MODEL HC451A |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
K033569 |
01/13/2004 |
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH |
FLOWMEDICA, INC. |
JEFF ELKINS |
K032667 |
01/23/2004 |
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) |
FOCUS MEDICAL, LLC. |
JOHN B LEE |
K042035 |
11/17/2004 |
ALUMINA HEAD |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
K034064 |
01/30/2004 |
FRESENIUS ULTRAFLO HPX HEMODIALYZER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K033193 |
01/23/2004 |
SONOSENS |
FRIENDLY SENSORS AG |
TRISH LANDRY |
K033377 |
01/09/2004 |
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FRANK GIANELLI |
K041903 |
11/10/2004 |
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 |
FUJINON, INC. |
JOSEPH M AZARY |
K042076 |
11/18/2004 |
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 |
FUJINON, INC. |
JOSEPH M AZARY |
K042043 |
11/24/2004 |
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 |
FUJINON, INC. |
JOSEPH M AZARY |
K042731 |
11/19/2004 |
ARCHITECT CA 125 II ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
KIMBERLY PETERSON |
K024185 |
01/15/2004 |
BIODHOC |
FUTURE MEDICAL SYSTEMS, SA |
STEVE JANIN |
K040301 |
11/01/2004 |
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
K033469 |
01/07/2004 |
GENESIS VERTICAL PLATFORM LIFT |
GARAVENTA ACCESSIBILITY |
NORM COOPER |
K042348 |
11/18/2004 |
GRADIA DIRECT LOFLO |
GC AMERICA, INC. |
TERRY JORITZ |
K042866 |
11/02/2004 |
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS |
GE HEALTHCARE TECHNOLOGIES |
D. DUERSTELER |
K042694 |
11/18/2004 |
ADVANCED LUNG ANALYSIS II |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K042642 |
11/03/2004 |
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ANDREW KLUESSENDORF |
K033964 |
01/15/2004 |
SOLAR 9500 INFORMATION MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ANDREW KLUESSENDORF |
K042844 |
11/03/2004 |
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
K033815 |
01/15/2004 |
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
K042559 |
11/17/2004 |
GEM-TWIN TENS/ MODELS GM3XY/Z |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
K042748 |
11/12/2004 |
GENEMAX POWER WHEELCHAIR, PW3 |
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. |
Ke-Min Jen |
K042749 |
11/12/2004 |
GENEMAX POWER WHEELCHAIR, PW4 |
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. |
Ke-Min Jen |
K043112 |
11/24/2004 |
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
K041239 |
11/08/2004 |
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 |
GENESIS MEDICAL TECHNOLOGY, INC. |
THOMAS KROENKE |
K041968 |
11/03/2004 |
GENICON BIPOLAR FORCEPS MODEL # 600-005-005 |
GENICON |
GARY HABERLAND |
K041967 |
11/12/2004 |
GENICON SUCTION IRRIGATION SYSTEM |
GENICON |
GARY HABERLAND |
K033409 |
01/21/2004 |
AMERSHAM HEALTH NEEDLE-GUARD |
GETTIG PHARMACEUTICAL INSTRUMENT CO. |
JAMES A BENZ |
K042960 |
11/24/2004 |
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO |
GIVEN IMAGING LTD. |
SHOSH FRIEDMAN |
K042953 |
11/22/2004 |
MODIFICATION TO PROTEX STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K042830 |
11/17/2004 |
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K033632 |
01/21/2004 |
VARIFLEX |
GREAT LAKES ORTHODONTICS, LTD. |
MARK LAUREN |
K041501 |
11/30/2004 |
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS |
GUANGZHOU FORTUNIQUE LTD. |
JANE B CAMPBELL |
K033834 |
01/02/2004 |
OMNILINK .018 BILIARY STENT SYSTEM |
GUIDANT CORP. |
MICHELLE GROSSMAN |
K042908 |
11/12/2004 |
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM |
GUIDANT CORP. |
VIRGINIA SINGER |
K040660 |
11/15/2004 |
STERICHEK GLUTARALDEHYDE REAGENT STRIPS |
HACH COMPANY |
DAVID A MORRIS |
DEN040009 |
11/04/2004 |
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) |
HAMILTON THORNE BIOSCIENCES |
DIARMAID DOUGLAS-HAMILTON |
K033406 |
01/15/2004 |
SMALL BONE FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
K033853 |
01/14/2004 |
MODIFICATION TO V-CATH POLY PICC |
HDC CORP. |
EARL SMART |
K042853 |
11/10/2004 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
K033796 |
01/30/2004 |
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS |
HEINZ KURZ GMBH MEDIZINTECHNIK |
ANGELIKA SCHERP |
K033628 |
01/16/2004 |
ARTIC |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K042980 |
11/17/2004 |
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE |
HOSPIRA, INC. |
PATRICIA MELERSKI |
K042883 |
11/23/2004 |
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
K034002 |
01/15/2004 |
GAMMA3 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K033476 |
01/20/2004 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K033342 |
01/15/2004 |
SCORPIO KNEE SYSTEM - TIBIAL INSERTS |
HOWMEDICA OSTEONICS CORP. |
DENISE DUCHENE |
K041170 |
11/09/2004 |
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K033837 |
01/08/2004 |
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K032315 |
11/18/2004 |
IOP8 INTRA OPERATIVE PROBE |
HUNTLEIGH HEALTHCARE, INC. |
B.J. COLLEYPRIEST |
K033744 |
01/20/2004 |
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA |
HYCOR BIOMEDICAL LTD. |
DANIELLE M KNIGHT |
K041007 |
11/15/2004 |
MILLENIUM, MODELS 2000, 2001 AND 2002 |
HYPERBARIC FOR LIFE LLC |
RICK RYDER |
K032796 |
01/13/2004 |
IBL C3D-CIC EIA TEST |
IBL GMBH |
Gary Lehnus |
K042697 |
11/19/2004 |
SECOND LOOK VIEWER |
ICAD INC. |
JOHN ROSENSTENGEL |
K031167 |
01/28/2004 |
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX |
IDT TECHNOLOGY LIMITED |
STEPHEN LI |
K042894 |
11/19/2004 |
IMALUX NIRIS IMAGING SYSTEM |
IMALUX CORPORATION |
STEPHANIE HARRINGTON |
K032263 |
01/28/2004 |
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
K031962 |
01/08/2004 |
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS |
IMPLEX CORP. |
MARCI HALEVI |
K033432 |
01/15/2004 |
LEXATITE QUICK ACRYLIC |
IMTEC CORP. |
BRAD VANCE |
K041817 |
11/19/2004 |
WEST NILE DETECT IGM ELISA |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
K030739 |
01/14/2004 |
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE |
INFUSION DYNAMICS, INC. |
THOMAS BECZE |
K042557 |
11/08/2004 |
INNOJECT AUTO-INJECTOR |
INNOJECT, INC |
JONATHAN S KAHAN |
K031896 |
01/14/2004 |
NASAL-AIR CRITICAL CARE |
INNOMED TECHNOLOGIES |
FRANK PELC |
K033922 |
01/07/2004 |
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
CAROLYN BITETTI |
K033414 |
01/12/2004 |
ACL TOP MODEL, TOP |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K033775 |
01/02/2004 |
HEMOSIL LIQUID ANTITHROMBIN XL |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K042798 |
11/04/2004 |
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K033929 |
01/12/2004 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K032031 |
01/07/2004 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K042855 |
11/12/2004 |
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K042538 |
11/08/2004 |
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX |
INVATEC INNOVATIVE TECHNOLOGIES |
MIKE WINEGAR |
K042537 |
11/08/2004 |
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX |
INVATEC INNOVATIVE TECHNOLOGIES |
MIKE WINEGAR |
K042775 |
11/04/2004 |
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
BONNIE BISHOP |
K033462 |
01/15/2004 |
EARLY CLEAVAGE MEDIUM (ECM) |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K033956 |
01/20/2004 |
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) |
IS2 RESEARCH, INC. |
VICTOR WOODBURN |
K033773 |
01/15/2004 |
CONCEPT HP ADD-ON; CONCEPT HP ENAMEL |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
K042848 |
11/22/2004 |
FRC POSTEC PLUS |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K042819 |
11/09/2004 |
TETRIC EVOCERAM |
IVOCLAR VIVADENT, INC. |
DONNA HARTNETT |
K020983 |
01/30/2004 |
JOSTRA SUCKERS, MODEL JS |
JOSTRA AG |
KATHLEEN JOHNSON |
K042900 |
11/05/2004 |
K.E.P. CONNECTOR AND CLIP |
K.E.P., LLC |
ROSINA ROBINSON |
K032886 |
01/09/2004 |
DIAMOND SETUP 2000 |
K&S ASSOC., INC. |
VIVIAN DEAN |
K042340 |
11/24/2004 |
KASIOS TCP |
KASIOS BIOMATERIALS |
LAETITA BERNARD |
K042872 |
11/23/2004 |
RONDOFLEX PLUS 360 |
KAVO AMERICA CORPORATION |
DANIEL KAMM |
K042572 |
11/05/2004 |
KENDALL CO2NFIRM NOW CO2 DETECTOR |
KENDALL |
BRIDGET GARDNER |
K042888 |
11/10/2004 |
DEMETRON IDS CURING LIGHT |
KERR CORP. |
COLLEEN BOSWELL |
K033483 |
01/15/2004 |
KLS-MARTIN ORTHO ANCHORAGE SYSTEM |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K042133 |
11/24/2004 |
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
K033938 |
01/29/2004 |
CLEARFIL PROTECT BOND |
KURARAY MEDICAL INC. |
KEITH A BARRITT |
K042913 |
11/26/2004 |
CLEARFIL TRI-S BOND |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
K042618 |
11/26/2004 |
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
K041747 |
11/24/2004 |
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) |
LIFEPOINT,INC |
DAVID B GOLDBERG |
K041746 |
11/23/2004 |
IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) |
LIFEPOINT,INC |
DAVID B GOLDBERG, PH.D. |
K042966 |
11/19/2004 |
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H |
LINVATEC BIOMATERIALS, LTD. |
TUIJA ANNALA |
K042778 |
11/04/2004 |
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE |
LINVATEC CORP. |
ELIZABETH PAUL |
K033535 |
01/07/2004 |
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES |
LUMEND, INC. |
MICHAEL A DANIEL |
K034031 |
01/21/2004 |
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE |
M.K. MEDITECH CO. LTD. |
ROSINA ROBINSON |
K031128 |
01/15/2004 |
B-SMART, MODEL B-01 |
MACOSTA MEDICAL USA, LLC |
PAMELA PAPINEAU |
K030418 |
01/29/2004 |
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM |
MAKAI MARINE INDUSTRIES, INC. |
MARC R KAISER |
K042744 |
11/30/2004 |
OPTIV ANTAGE DH POWER INJECTION SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
ELLIS ROGERS |
K033349 |
01/28/2004 |
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 |
MASIMO CORP. |
JAMES J CRONIN |
K033413 |
01/07/2004 |
SPINEASSIST DEVICE |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
K042228 |
11/08/2004 |
BEELINE MOTIV, PROPOLIS, PCA |
MCKINLEY, INC. |
MICHELLE PRATTE |
K033835 |
01/22/2004 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR |
MDM ENTERPRISE CORP. |
ELIZABETH DENG |
K042382 |
11/30/2004 |
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD |
MED-GENERAL TECHNOLOGIES LLC |
PAUL MCCREIGHT |
K033293 |
01/13/2004 |
MED-LOGICS, MODEL ML7090 |
MED-LOGICS, INC. |
ROD ROSS |
K031908 |
01/14/2004 |
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 |
K040328 |
11/24/2004 |
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER |
MEDCOMP |
ROSANNA SEVERINI |
K042527 |
11/08/2004 |
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 |
MEDICAL ACTION INDUSTRIES, INC. |
ROBIN BLANKENBAKER |
K042717 |
11/05/2004 |
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
MARY THORSNESS |
K042359 |
11/17/2004 |
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL |
MEDICAL DESIGNS, LLC |
PAUL JOHN AXT |
K031995 |
01/07/2004 |
COMPREHENSIVE NEUROMUSCULAR PROFILER |
MEDICAL TECHNOLOGIES UNLIMITED, INC. |
ANGELA MORRIS |
K040744 |
11/30/2004 |
ATRILAZE SOFT TISSUE ABLATION SYSTEM |
MEDICALCV, INC. |
DENNY STEGER |
K041284 |
11/22/2004 |
MEDICULT IVM SYSTEM |
MEDICULT A/S |
RONALD G LEONARDI |
K031617 |
01/16/2004 |
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER |
MEDIPLUS LTD. |
NORMAN F ESTRIN |
K030598 |
01/23/2004 |
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS |
MEDISISS |
MARY ANN BARKER |
K031686 |
01/21/2004 |
AEROMIST LT, MODEL HCS15004 |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
K031321 |
01/21/2004 |
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 |
MEDLOGIC GLOBAL LIMITED |
MEL LONGHURST |
K030901 |
11/26/2004 |
MEDTRADE PRODICT'S SOOTHING GEL PATCH |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
K033989 |
01/22/2004 |
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 |
MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT |
KRISTY K MOLLNER |
K033850 |
01/13/2004 |
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K042790 |
11/04/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042886 |
11/18/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042210 |
11/04/2004 |
MSD SILO SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042922 |
11/19/2004 |
VENTURE ANTERIOR CERVICAL PLATING SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K034058 |
01/29/2004 |
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 |
MEDTRONIC VASCULAR |
PREETI JAIN |
K042859 |
11/24/2004 |
KOBRA GPS FIXATION SYSTEM |
MEDTRONIC VERTELINK, INC. |
ALBERT REGO |
K042851 |
11/09/2004 |
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT |
MENTOR CORP. |
DONNA CRAWFORD |
K042769 |
11/24/2004 |
ADSEAL ROOT CANAL SEALER |
META BIOMED CO., LTD. |
JENNY SHON |
K033372 |
01/09/2004 |
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K042171 |
11/10/2004 |
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 |
MICRO-MEGA SOCIETE ANONYME |
PHILIPPE GARCIA |
K034023 |
01/15/2004 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K033817 |
01/08/2004 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K033818 |
01/08/2004 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K041852 |
11/15/2004 |
MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 |
MINRAD, INC. |
JOHN MCNEIRNEY |
K033095 |
11/17/2004 |
SMOKE EVACUATION ATTACHEMENT |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
K023506 |
01/13/2004 |
SURGICAL MEDICAL DEVICE CAUTERY |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
ROGER STRUBE |
K041632 |
11/17/2004 |
MINIMESH POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
K033447 |
01/28/2004 |
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K042353 |
11/24/2004 |
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS |
NATIONAL DISPLAY SYSTEMS |
RON HANSEN |
K042339 |
11/02/2004 |
NEOPLANT IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
DAE KYU CHANG |
K041323 |
11/17/2004 |
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
K030780 |
01/23/2004 |
NEWPORT E500 WAVE VENTILATOR |
NEWPORT MEDICAL INSTRUMENTS, INC. |
RICHARD WATERS |
K041861 |
11/26/2004 |
NEXUS INTRAVENOUS TUBING SETS (NIVTS) |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
K033302 |
01/26/2004 |
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
K033475 |
01/07/2004 |
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K043042 |
11/18/2004 |
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
K033621 |
01/27/2004 |
NDI PASSIVE SPHERES |
NORTHERN DIGITAL, INC. |
NANCY RUTH |
K042434 |
11/03/2004 |
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 |
NOUVAG AG |
ERICH FORSTER |
K033433 |
01/02/2004 |
NOVA GLUCOSE CONTROL SOLUTIONS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K033328 |
01/16/2004 |
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT |
NOVOSCI CORP. |
LEANN LATHAM |
K042089 |
11/24/2004 |
NX STAGE WATER PURIFICATION SYSTEM |
NX STAGE MEDICAL INC |
NORMA LEMAY |
K033651 |
01/30/2004 |
OLYMPUS VIDEO URETEROSCOPE, NTSC |
OLYMPUS WINTER & IBE GMBH |
TINA STEFFANIE-OAK |
K043018 |
11/10/2004 |
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 |
OMRON HEALTHCARE, INC. |
LARRY LEPLEY |
K033877 |
01/16/2004 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR |
ONE TOUCH PRODUCTS CO., LTD. |
ELIZABETH DENG |
K041983 |
11/17/2004 |
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 |
OPTICON MEDICAL |
GLENN D BRUNNER |
K033830 |
01/09/2004 |
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 |
OPTICON MEDICAL, INC. |
GERARD J PRUD'HOMME, ESQ. |
K042914 |
11/12/2004 |
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
K042809 |
11/02/2004 |
CUFFPATCH |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
K042665 |
11/23/2004 |
SMART BITEBLOC |
ORIDION MEDICAL 1987 LTD. |
SANDY BROWN |
K042625 |
11/18/2004 |
QUIKREAD CRP CALIBRATOR SET |
ORION DIAGNOSTICA OY |
ANNIKHA RANTAMA |
K042643 |
11/18/2004 |
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K042521 |
11/18/2004 |
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K042520 |
11/30/2004 |
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
K042475 |
11/10/2004 |
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K042477 |
11/19/2004 |
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K042816 |
11/10/2004 |
TRAUMACAD 1.2 |
ORTHOCRAT, LTD. |
ADI ICKOWICZ |
K042766 |
11/16/2004 |
ORTHOFIX VOLAR DISTAL RADIAL PLATE |
ORTHOFIX, INC. |
NICOLLE L FERRIS |
K033286 |
01/12/2004 |
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM |
ORTHOPEDIC DESIGNS, INC. (ODI) |
JOHN SODEIKA |
K041443 |
11/16/2004 |
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K031936 |
01/07/2004 |
OSTEOMED ORTHODONTIC SCREW SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
K033120 |
01/29/2004 |
SCALETRON PIEZO ULTRASOUND SCALER |
PAC-DENT INTERNATIONAL (SUZHOU), LTD. |
DANIEL WANG |
K042653 |
11/26/2004 |
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP |
PACK & PROPER CO., LTD. |
JEN KE-MIN |
K033991 |
01/22/2004 |
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET |
PALL MEDICAL |
JONATHAN S KAHAN |
K042950 |
11/30/2004 |
VAG O SPECULUM, MODELS VS1, VM1, VL1 |
PANATREX, INC. |
KEVIN KUO |
K033507 |
01/20/2004 |
MRJ |
PARAMED SRL |
DIANA UPTON |
K040912 |
11/16/2004 |
HYDROGEL CANALICULAR PLUG |
PARTNERS IN BIOMATERIALS, INC. |
JAMES CHRISTENSEN |
K042877 |
11/16/2004 |
MICROVERTER URETERAL ACCESS SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
K031809 |
01/23/2004 |
PERIO PROTECT TRAY |
PERIO PROTECT LLC |
DAVID L ROSEN |
K032765 |
01/30/2004 |
STREET |
PERMOBIL A.B. |
BENGT PERSSON |
K033513 |
01/15/2004 |
EASI ECG ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
K042867 |
11/02/2004 |
PHILIPS ORTHOPAEDIC APPLICATIONS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN T HARMER |
K033357 |
01/09/2004 |
ACQSIM-MULTISLICE-CT, MODEL 453567042271 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT B SMITH |
K042935 |
11/09/2004 |
GEMINI GXL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
RAE ANN FARROW |
K042845 |
11/12/2004 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
EGON PFEIL |
K034003 |
01/08/2004 |
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
LYNN HARMER |
K042881 |
11/18/2004 |
PMD-2000 INTERFERENTIAL STIMULATOR |
PHOENIX MEDICAL DEVICES, LLC |
JIM KLETT |
K022908 |
01/22/2004 |
POSTERIOR CABLE SCREW |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
K042671 |
11/19/2004 |
PLANMED SOPHIE NUANCE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
K032126 |
01/08/2004 |
PROMOS SHOULDER |
PLUS ORTHOPEDICS |
J.D. WEBB |
K041882 |
11/23/2004 |
FLOWCARE SYSTEM |
POINTCARE TECHNOLOGIES INC. |
CYNTHIA A SINCLAIR |
K042811 |
11/08/2004 |
VIVOSORB SHEET, MODEL FS01 |
Polyganics BV |
JAN NIEUWENHUIS |
K032112 |
01/26/2004 |
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) |
PORTEX LTD. |
STEVE OGILVIE |
K032641 |
01/20/2004 |
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM |
PORTLAND ORTHOPAEDICS PTY. LTD. |
DAVID SEKEL |
K042874 |
11/05/2004 |
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
K033726 |
01/16/2004 |
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER |
PRECISION VASCULAR |
RICK GAYKOWSKI |
K033309 |
01/26/2004 |
PREMIER IMPLANT CEMENT, MODEL 3001450 |
PREMIER DENTAL PRODUCTS CO. |
BARRY HALE |
K040708 |
11/22/2004 |
STATUS FIRST STREP A |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K033449 |
01/07/2004 |
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES |
PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC |
JOANN UNDERWOOD |
K033779 |
01/26/2004 |
VIANOX DELIVERY SYSTEM, MODEL II |
PULMONOX MEDICAL, INC. |
PAULA TOMAT |
K042645 |
11/26/2004 |
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
K033915 |
01/16/2004 |
MODIFICATION TO SERAQUEST EB VCA IGG |
QUEST INTL., INC. |
ROBERT A CORT |
K033780 |
01/15/2004 |
MODIFICATION TO SERAQUEST VCA IGM |
QUEST INTL., INC. |
ROBERT A CORT |
K042919 |
11/29/2004 |
FIBROTEK FIB |
R2 DIAGNOSTICS, INC. |
PEGGY S CARTER |
K040028 |
01/22/2004 |
CA-1500 |
R2 TECHNOLOGY, INC. |
Kathy O'Shaughnessy |
K041143 |
11/05/2004 |
RANDOX BARBITURATE ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K041142 |
11/23/2004 |
RANDOX CANNABINOIDS ASSSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K041144 |
11/03/2004 |
RANDOX OPIATES ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K032882 |
01/28/2004 |
RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 |
RECOM MANAGED SYSTEMS, INC. |
WILLAM R MATTHEWS |
K032799 |
01/20/2004 |
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER |
REICHERT INC. |
FRANK DREXELIUS |
K041951 |
11/15/2004 |
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B |
REMEL INC |
MARY ANN SILVIUS |
K041937 |
11/16/2004 |
RESTITU |
RESONANT MEDICAL, INC. |
SEAN M CURRY |
K042601 |
11/19/2004 |
CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX, INC. |
KEVIN MADER |
K034040 |
01/21/2004 |
ESPRIT VENTILATOR, MODEL V1000 |
RESPIRONICS, INC. |
ANIL BHALANI |
K040044 |
01/27/2004 |
HEEL SNUGGLER, MODEL 99047 |
RESPIRONICS, INC. |
ZITA A YURKO |
K043175 |
11/24/2004 |
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K033937 |
01/07/2004 |
ELECSYS PRECICONTROL MULTIANALYTE |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K043095 |
11/23/2004 |
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K032334 |
01/12/2004 |
ROCHE ONLINE TDM LIDOCAINE |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K032332 |
01/12/2004 |
ROCHE ONLINE TDM QUINIDINE |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K042264 |
11/24/2004 |
GUIDEWIRES |
ROCKET MEDICAL PLC |
T. CHARLTON |
K032585 |
01/09/2004 |
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM |
RON-TECH MEDICAL LTD. |
DORON KILCHEVSKY |
K033391 |
01/12/2004 |
MEDICAL MAGGOTS |
RONALD A. SHERMAN |
RONALD A SHERMAN |
K042773 |
11/23/2004 |
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K033660 |
01/07/2004 |
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 |
RUDOLF STORZ GMBH |
ANGELIKA SCHERP |
K042614 |
11/22/2004 |
S&C-SELF ETCH PR-BOND |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
K040021 |
11/02/2004 |
SHUNTCHECK (PROMETHEUS 1) |
SAMUEL NEFF M.D. |
SAMUEL NEFF |
K042964 |
11/22/2004 |
MX MONOAXIAL PEDICLE SCREW |
SCIENT'X |
J.D. WEBB |
K033939 |
01/30/2004 |
FLOSENSE II, MODEL 29-8040 |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
K033268 |
01/07/2004 |
SEA-BAND |
SEA-BAND UK LTD. |
NEIL R ARMSTRONG |
K043002 |
11/18/2004 |
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR |
SEDECAL S.A. |
DANIEL KAMM |
K042876 |
11/18/2004 |
URS LP DIGITAL, MILLENNIUM, RADPRO |
SEDECAL S.A. |
DANIEL KAMM |
K042307 |
11/03/2004 |
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) |
SERADYN INC. |
JACK ROGERS |
K033539 |
01/08/2004 |
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
K033693 |
01/16/2004 |
POWDER-FREE VINYL EXAMINATION GLOVES |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
K033692 |
01/16/2004 |
POWDERED VINYL EXAMINATION GLOVES |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
K042119 |
11/03/2004 |
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHEN YUHONG |
K042120 |
11/04/2004 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHEN YUHONG |
K042617 |
11/05/2004 |
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
NEALIE HARTMAN |
K040060 |
01/28/2004 |
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
K043016 |
11/16/2004 |
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
K042995 |
11/24/2004 |
X-LEONARDO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ANA LADINO |
K042718 |
11/12/2004 |
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS, INC. |
NEALIE HARTMAN |
K043082 |
11/23/2004 |
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K032966 |
01/13/2004 |
THE ANSWER SCREW SUPPLEMENTATION SYSTEM |
SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC |
BARRY T BICKLEY |
K033675 |
01/15/2004 |
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
K031860 |
01/21/2004 |
SK MED ME202 MONITORING MIXER |
SK MED |
DIPAK GHOSH |
K034005 |
11/18/2004 |
SDS-4I |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE CHIANG |
K033683 |
01/08/2004 |
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K033289 |
01/13/2004 |
MODIFICATION TO JET-X HA COATED HALF PINS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K042127 |
11/19/2004 |
SMITH & NEPHEW MODULAR HIP |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
K043052 |
11/24/2004 |
TRIGEN HINDFOOT FUSION NAIL |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
K033686 |
01/23/2004 |
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM |
SMITHS MEDICAL MD, INC. |
PATRICIA A LAFORTE |
K033376 |
01/15/2004 |
UGYTEX MESH |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
K042619 |
11/05/2004 |
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT |
SONOTECH, INC. |
MARGARET J LARSON |
K023713 |
01/28/2004 |
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 |
SONTRA MEDICAL INC. |
ALBERT FARINHA |
K033310 |
01/15/2004 |
REMEEX SYSTEM FOR URINARY INCONTINENCE |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
K040684 |
11/05/2004 |
T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 |
SPECTROS CORPORATION |
DAVID A BENARON |
K033772 |
01/27/2004 |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
SPINE NEXT AMERICA |
DIANE JOHNSON |
K033508 |
01/27/2004 |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
K042640 |
11/23/2004 |
UNI-THREAD SPINAL SYSTEM |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
K032124 |
01/16/2004 |
DUREX PLAY LUBRICANT |
SSL AMERICAS, INC. |
KATHLEEN HARRIS |
K042733 |
11/15/2004 |
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
K042909 |
11/12/2004 |
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
K032303 |
01/16/2004 |
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
K033019 |
01/22/2004 |
SUNPEX TECHNOLOGIES MODEL SE03 |
SUNPEX TECHNOLOGY CO., LTD. |
LEONARD FRIER |
K042438 |
11/08/2004 |
SUPERDIMENSION/BRONCHUS |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
K042211 |
11/08/2004 |
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS |
SURGICAL LASER TECHNOLOGIES, INC. |
BOB ROSE |
K042555 |
11/09/2004 |
SURGICHIP TAG SURGICAL MARKER |
SURGICHIP, INC. |
BRUCE WAXMAN |
K033182 |
01/30/2004 |
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HAAR |
K043008 |
11/17/2004 |
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM |
SURGRX, INC. |
LINDA OLESON |
K042422 |
11/15/2004 |
D3 CHROMA |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K032514 |
01/27/2004 |
AC APPLICATOR, AURORA AC |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
K041959 |
11/08/2004 |
POLARIS DS/COMET |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
K040141 |
01/30/2004 |
EMORY CARDIAC TOOLBOX VERSION 2.6 |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
K042986 |
11/17/2004 |
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
K042987 |
11/23/2004 |
MODIFICATION TO SYNTHES CRANIAL PLATES |
SYNTHES (USA) |
LISA M BOYLE |
K033556 |
01/13/2004 |
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM |
SYNTHES (USA) |
BONNIE SMITH |
K042365 |
11/18/2004 |
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K042895 |
11/16/2004 |
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K033403 |
01/22/2004 |
T.S. MEDICAL CIRCUMCISION CLAMP |
T.S. MEDICAL |
CAROLANN KOTULA |
K042652 |
11/04/2004 |
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR |
TAIWAN KING STRONG CO., LTD. |
KE-MEN JEN |
K033654 |
01/15/2004 |
FORCE FIBER |
TELEFLEX MEDICAL |
LYNN MATOS |
K042152 |
11/22/2004 |
BINDING SITE IGG SUBLCASS OLYMPUS KITS |
THE BINDING SITE |
JAY H GELLER |
K041891 |
11/05/2004 |
MININEPH HUMAN RHEUMATOID FACTOR KIT |
THE BINDING SITE |
JAY H GELLER |
K033811 |
01/30/2004 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
K032101 |
01/22/2004 |
POWERSTAND STAND-UP WHEELCHAIR |
THE STANDING CO., INC. |
MICHAEL A OLVERA |
K032141 |
01/28/2004 |
SECUMAX BLOOD COLLECTION SYSTEM |
TIGER MEDITECH INCORPORATED |
SHU-CHEN CHENG |
K042739 |
11/03/2004 |
HI-ART SYSTEM |
TOMOTHERAPY INCORPORATED |
KENNETH D BUROKER |
K041367 |
11/05/2004 |
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
DONALD H WINFIELD |
K043078 |
11/17/2004 |
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K043111 |
11/18/2004 |
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K033146 |
11/23/2004 |
TONO-PEN TONOMETER TIP COVER |
TRA & ACCESSORIES |
RICHARD MASTROLEO |
K032891 |
01/15/2004 |
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT |
TRANS1, INC. |
W. ALLEN PUTNAM |
K043012 |
11/17/2004 |
OMNIPULSE MINI, MODEL 2120 |
TRIMEDYNE, INC. |
GLENN YEIK |
K032972 |
01/14/2004 |
AEROCHAMBER MAX VALVED HOLDING CHAMBER |
TRUDELL MEDICAL INTL. |
TOM HOLBROOK |
K033033 |
11/22/2004 |
VIZILITE-BLUE ORAL EXAM KIT |
TRYLON CORP. |
MARTIN L LONKY |
K033658 |
01/16/2004 |
E.P.T. PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
K033490 |
01/09/2004 |
SPIRIT 5000 CARDIAC COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
K042256 |
11/17/2004 |
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE |
USA LASER BIOTECH INC. |
M. JOYCE HEINRICH |
K042216 |
11/12/2004 |
COOL-TIP RF ABLATION SYSTEM |
VALLEYLAB |
CHARLES COPPERBERG |
K033902 |
01/20/2004 |
ONTRAK TESTCUP II AND ONSITE CUPKIT |
VARIAN INC |
LORNA GAMBOA |
K033659 |
01/06/2004 |
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK |
VARIAN INC |
LORNA GAMBOA |
K042566 |
11/08/2004 |
VASC-ALERT |
VASC-ALERT, INC. |
JOHN B KENNEDY |
K030864 |
01/30/2004 |
VADI MANUAL RESUSCITATOR |
VEDI CORP. |
ERIC LUO |
K042910 |
11/22/2004 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
VELOCIMED INC. |
JOHN CARLINE |
K042468 |
11/17/2004 |
IVENT 201 PORTABLE VENTILATOR |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
K033547 |
01/07/2004 |
VNUS VESSEL AND TISSUE COAGULATION SYSTEM |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
K042670 |
11/01/2004 |
FUTURABOND NR |
VOCO GMBH |
GERALD W SHIPPS |
K042996 |
11/24/2004 |
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE |
VOLCANO THERAPEUTICS, INC. |
LORRY HUFFMAN |
K042188 |
11/10/2004 |
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM |
VOLCANO THERAPEUTICS, INC. |
JAMES FARNWORTH |
K033982 |
01/22/2004 |
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST |
VYSIS |
KERRY J FLOM |
K033927 |
01/15/2004 |
ARTHOSCOPY PUMP A115 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
K042549 |
11/08/2004 |
MULTI CHEM CAL B |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K042551 |
11/16/2004 |
MULTI-CHEM CALIBRATOR A |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K042550 |
11/08/2004 |
MULTI-LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K042516 |
11/08/2004 |
OTOMIMIX |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K042948 |
11/03/2004 |
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM |
WANDONG MEDICAL |
WANG WEIMIN |
K033890 |
01/15/2004 |
ADVANCE DOUBLE HIGH INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
K033456 |
01/28/2004 |
EVOLVE RADIAL PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
K031402 |
11/22/2004 |
PERFECTA FEMORAL STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K042466 |
11/24/2004 |
X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE |
ZEST ANCHORS, INC. |
PAUL ZUEST |
K042702 |
11/23/2004 |
SILHOUETTE SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
TIM CRABTREE |
K043061 |
11/23/2004 |
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX |
ZIMMER TRABECULAR |
MARCI HALEVI |
K042776 |
11/04/2004 |
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX |
ZIMMER, INC. |
KAREN CAIN |
K042761 |
11/17/2004 |
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES |
ZIMMER, INC. |
NOAH BARTSCH |
K042337 |
11/04/2004 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
ZIMMER, INC. |
DALENE BINKLEY |
K033363 |
01/16/2004 |
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM |
ZIMMER, INC. |
STEPHEN MCKELVEY |