FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K010142 |
02/01/2001 |
OCO DENTAL IMPLANT |
"O" CO., INC. |
DAVID D DALISE |
K011255 |
12/20/2001 |
3D LINE STEROTACTIC HARDWARE ACCESSORIES |
3D LINE USA, INC. |
KAREN H RIGAMONTI |
K010056 |
02/01/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
K003762 |
02/28/2001 |
ALI 3D TOOL MODULE FOR MEDICAL IMAGES |
A.L.I. TECHNOLOGIES, INC. |
ROBERT MACNEIL |
K003512 |
02/08/2001 |
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II |
A.R.C. LASER AG |
DANIEL HOEFER |
K012014 |
12/05/2001 |
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
EVE A CONNER |
K013538 |
12/14/2001 |
ETHANOL |
ABBOTT LABORATORIES |
ALICIA SIMPSON |
K013683 |
12/06/2001 |
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE |
ABBOTT VASCULAR INC. |
PATTY HEVEY |
K002075 |
02/02/2001 |
ACE SDS 3.75MM SCREW DENTAL IMPLANT |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
K013972 |
12/17/2001 |
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 |
ACKARD LABORATORIES |
RICHARD HETTENBACH |
K013380 |
12/18/2001 |
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K010238 |
02/06/2001 |
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ |
ACTHERM, INC. |
RICHARD HSIEH |
K013616 |
12/19/2001 |
POLARUS CAP SCREW |
ACUMED, INC. |
SHARI JEFFERS |
K002237 |
02/02/2001 |
P3IMRT TM |
ADAC LABORATORIES |
JANICE E BROWN |
K003612 |
02/20/2001 |
MICROSPEED EC MOTORSYSTEM GD650/GD653 |
AESCULAP, INC. |
JOYCE THOMAS |
K003608 |
02/20/2001 |
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY |
AESCULAP, INC. |
LISA M MILLINGTON |
K003940 |
02/08/2001 |
2010 PLUS HOLTER FOR WINDOWS |
AGILENT TECHNOLOGIES |
GRETEL LUMLEY |
K002758 |
02/22/2001 |
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A |
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
EGON PFEIL |
K010048 |
02/01/2001 |
M2376A DEVICELINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
K010342 |
02/14/2001 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
K013302 |
12/17/2001 |
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K010211 |
02/15/2001 |
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K003252 |
02/21/2001 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
K003638 |
02/13/2001 |
MOJAVE CATARACT EXTRACTION SYSTEM |
ALLERGAN, INC. |
MARK O'DONNELL |
K012631 |
12/06/2001 |
REPROCESSED SOFT TISSUE ABLATORS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
K001585 |
02/13/2001 |
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE |
AMERICAN BIOCURVE, INC. |
MARTIN DALSING |
K002910 |
02/07/2001 |
HOLY DRAGON ACUPUNCTURE NEEDLES |
ANC IMPORT & EXPORT CO. LTD. |
WILLIAM ZHANG |
K013813 |
12/14/2001 |
MODIFICATION TO:APEX MEDICAL IF-4100 |
APEX MEDICAL CORP. |
ALAN CHANGE |
K012029 |
12/31/2001 |
REMEDY MODEL 2Z12 |
APOLLO CORP. |
ADRIAN SWEEN |
K003443 |
02/01/2001 |
SUCTION IRRIGATOR |
APPLIED MEDICAL |
ANIL BHALANI |
K012968 |
12/03/2001 |
APPLIED ACCESS SEAL |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K002054 |
02/16/2001 |
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 |
APPRIVA MEDICAL, INC. |
MICHAEL KOLBER |
K011212 |
12/20/2001 |
FILTERFLO H |
ARC MEDICAL, INC. |
HAL NORRIS |
K013320 |
12/19/2001 |
BLUE LATEX EXAMINATION GLOVES, POWDER FREE |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
K013334 |
12/13/2001 |
ENDOFLIP |
ARTHOCARE CORPORATION |
NICK WOODS |
K003651 |
02/21/2001 |
AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
JAMES J ROGERS |
K013818 |
12/05/2001 |
AUTOGENESIS AUTOMATOR, MODEL M1000 |
AUTOGENESIS, INC. |
JAMES EDWARDS |
K013231 |
12/03/2001 |
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L |
AVID N.I.T., INC. |
SCOTT HENDERSON |
K003041 |
02/07/2001 |
ULTRASOUND SCANNER TYPE 2101 |
B-K MEDICAL A/S |
VILLY BRAENDER |
K003749 |
02/23/2001 |
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN |
BANTA HEALTHCARE |
YOLNDA SMITH |
K012988 |
12/05/2001 |
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
K002210 |
02/14/2001 |
SYNTRA DIALYZER, MODEL SYNTRA 120, 160 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
K003796 |
02/05/2001 |
ADVIA 120 HEMATOLOGY |
BAYER CORP. |
FREDRICK CLERIE |
K012337 |
12/06/2001 |
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM |
BAYER CORP. |
KENNETH T EDDS |
K013568 |
12/21/2001 |
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER CORP. |
KENNETH T EDDS |
K013606 |
12/21/2001 |
ACS 180 HOMOCYSTEINE ASSAY |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K010050 |
02/05/2001 |
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY |
BAYER DIAGNOSTICS CORP. |
THOMAS F FLYNN |
K013406 |
12/18/2001 |
ADVIA CENTAUR HOMOCYSTEINE ASSAY |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K012183 |
12/27/2001 |
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY |
BAYER DIAGNOSTICS CORP. |
BARBARA PREISEL-SIMMONS |
K990284 |
02/01/2001 |
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K003461 |
02/01/2001 |
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
M. WENDY BOSSHARDT |
K010064 |
02/07/2001 |
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K010066 |
02/07/2001 |
5C-ES CELL CONTROL, MODELS 7547191, 7547192 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K013842 |
12/13/2001 |
IMMUNO-TROL LOW CELLS |
BECKMAN COULTER, INC. |
LOURDES COBA |
K014034 |
12/18/2001 |
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K013076 |
12/12/2001 |
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K013800 |
12/21/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
K002650 |
02/16/2001 |
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 |
BENTEC MEDICAL, INC. |
DAVID TUCKER |
K003641 |
02/08/2001 |
BIOLOK SCREW, BIOSTEON SCREW |
BIOCOMPOSITES LTD. |
J.STEPHEN BRATT |
K013193 |
12/21/2001 |
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE |
BIOLITEC, INC. |
CAROL J MORELLO |
K003795 |
02/14/2001 |
BIOLUCENT MAMMOGRAPHY CUSHION |
BIOLUCENT, INC. |
STEVE GEX |
K003856 |
02/21/2001 |
EZ-HCG URINE(PREGNANCY TEST) |
BIOMERICA, INC. |
JAY SINGH |
K012469 |
12/03/2001 |
RESORBABLE NO PROFILE SCREW AND WASHER |
BIOMET MANUFACTURING, INC. |
SARA B SHULTZ |
K013657 |
12/03/2001 |
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
K013534 |
12/17/2001 |
SELF-COUNTERSINKING BONE SCREW |
BIOMET ORTHOPEDICS, INC. |
SARA B SHULTZ |
K003493 |
02/09/2001 |
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT |
BIOMET, INC. |
SARA A BAILEY |
K993836 |
12/19/2001 |
GENERATION 4 BONE CEMENT |
BIOMET, INC. |
MARY VERSTYNEN |
K011139 |
12/20/2001 |
LORENZ LACTOSORB PANELS AND FASTENERS |
BIOMET, INC. |
TRACY J BICKEL |
K012569 |
12/21/2001 |
MODIFICATION TO: INJECTABLE MIMIX |
BIOMET, INC. |
SARA B SHULTZ |
K010212 |
02/14/2001 |
OFFSET TIBIAL TRAY |
BIOMET, INC. |
CAROL LAUSTER |
K011451 |
12/10/2001 |
REUNITE FUSION SCREW |
BIOMET, INC. |
SARA BAILEY SHULTZ |
K012572 |
12/03/2001 |
SOFT TISSUE SCREW AND WASHER |
BIOMET, INC. |
SARA B SHULTZ |
K003659 |
02/20/2001 |
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
K003757 |
02/07/2001 |
THERMOFX MESH |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
K013055 |
12/07/2001 |
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
CAROL E JONES |
K013050 |
12/10/2001 |
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
CAROL E JONES |
K002642 |
02/05/2001 |
MINIQUANT D-DIMER, MODEL 1447 |
BIOPOOL INTL., INC. |
MICHAEL D BICK |
K010057 |
02/02/2001 |
MODIFICATION TO ARTOSCAN M |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
K013289 |
12/27/2001 |
BIOTEQUE VAGINAL PESSARIES |
BIOTEQUE AMERICA, INC. |
DENIS DORSEY |
K013151 |
12/14/2001 |
ASMOTOM AUTOMATED TREPHINE SYSTEM |
BKG OPTHALMICS USA, INC. |
ART WARD |
K013177 |
12/19/2001 |
MULTITAK SUTURE SNAP SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
K013866 |
12/14/2001 |
CONVOY ADVANCED DELIVERY SHEATH KIT |
BOSTON SCIENTIFIC |
ANDREA L RUTH |
K003782 |
02/14/2001 |
CONSTELLATION CATHETER, MODEL 8031 |
BOSTON SCIENTIFIC CORP. |
ANDREA BOUMIS |
K011889 |
12/21/2001 |
ULTRA -THIN SDS BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
K013789 |
12/06/2001 |
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 |
BOSTON SCIENTIFIC, TARGET |
GEORGE J PRENDERGAST |
K003268 |
02/22/2001 |
Z-TOUCH |
BRAINLAB, AG |
|
K013928 |
12/03/2001 |
PAIN CARE 3200 |
BREG, INC. |
KATHLEEN BARBER |
K010343 |
02/14/2001 |
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 |
BUCK MEDICAL RESEARCH |
REBECCA ELLIS |
K011589 |
12/26/2001 |
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M |
BYPASS LTD. |
JONATHAN S KAHAN |
K010444 |
02/28/2001 |
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP |
C.R. BARD, INC. |
KERRY CHUNKO |
K010169 |
02/13/2001 |
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
CAROL VIERLING |
K012686 |
12/13/2001 |
CAIRD TECHNOLOGY HOLTER 2000 |
CAIRD TECHNOLOGY |
JAMES H BROWN |
K013251 |
12/18/2001 |
SPIRIT 300 |
CAIRE, INC. |
ROGER BRIESE |
K013907 |
12/18/2001 |
INVERNESS MEDICAL EARLY PREGNANCY TEST |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
AVRIL MURRAY |
K013807 |
12/12/2001 |
MICROJET QUARK, MODEL U100 OR U40 |
CANE SRL |
DANIEL KAMM |
K013753 |
12/10/2001 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
CANOPUS MEDICAL SUPPLY CO., LTD. |
ELIZABETH DENG |
K013019 |
12/18/2001 |
DATACAPTOR |
CAPSULE TECHNOLOGIE |
DANIEL KAMM |
K013901 |
12/20/2001 |
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) |
CARDIOFOCUS, INC. |
JOSEPH CURTIS |
K010261 |
02/28/2001 |
CARDIOMEDICS ECP SYSTEM |
CARDIOMEDICS, INC. |
JOHN HUTCHINS |
K003885 |
02/22/2001 |
VISULAS YAG II |
CARL ZEISS, INC. |
SCOTT A MARGOLIN |
K010349 |
02/28/2001 |
DUAL LUMEN MIDLINE CATHETER |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
K013512 |
12/20/2001 |
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
K012731 |
12/26/2001 |
SOLO-CARE PLUS MULTIPURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
K003586 |
02/08/2001 |
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES |
CIBA-GEIGY CORP. |
STEVEN DOWDLEY |
K011849 |
12/10/2001 |
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS |
CIRCON VIDEO |
WAYNE B STERNER |
K013721 |
12/28/2001 |
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
THERESA LEINEN |
K011454 |
12/13/2001 |
SPINE SCOPE, MODEL 2180 |
CLARUS MEDICAL, LLC. |
TOM BARTHEL |
K003833 |
02/13/2001 |
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR |
CLEARLAB PTE LTD. |
JOHN M SZABOCSIK |
K003958 |
02/06/2001 |
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
K003549 |
02/15/2001 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS |
Codman & Shurtleff, Inc. |
JAMES M FLAHERTY |
K013877 |
12/19/2001 |
CODMAN SLIM-LOC SYSTEM |
Codman & Shurtleff, Inc. |
KATHRYN WUNDER |
K013400 |
12/10/2001 |
SYNERGY FLOW |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
K013804 |
12/10/2001 |
SOCRATES ROBOTIC TELEMONITORING SYSTEM |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
K013112 |
12/05/2001 |
FOCAL SIM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
K011893 |
12/06/2001 |
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES |
CONTACT COLOR SRL |
Maria E Donawa |
K002958 |
12/18/2001 |
SHAPEABLE DOPPLER FLOW PROBE |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
K013916 |
12/20/2001 |
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
HEIDI MASTEN |
K003666 |
02/08/2001 |
TAPER-FIT TOTAL HIP SYSTEM |
CORIN U.S.A. |
JOEL K BATTS |
K010243 |
02/15/2001 |
TRI-FIT FEMORAL STEM |
CORIN U.S.A. |
JOEL K BATTS |
K003567 |
02/12/2001 |
SERENOCEM, MODEL BC 010 |
CORINTHIAN MEDICAL LTD. |
DAGMAR MASER |
K001631 |
02/22/2001 |
CORTEX METAMAX |
CORTEX BIOPHYSIK GMBH |
ART WARD |
K981052 |
12/18/2001 |
CRESCO TI IMPLANT CONCEPT |
CRESCO TI SYSTEMS AB |
PER E NILSSON |
K012327 |
12/20/2001 |
CSIST DICOM GATEWAY/IMAGE MANAGER |
CSIST |
CARL ALLETO |
K010210 |
02/21/2001 |
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 |
CURON MEDICAL, INC. |
THOMAS C WEHMAN |
K013878 |
12/07/2001 |
CYBERMED, INC., V-WORKS |
CYBERMED, INC. |
GARY J ALLSEBROOK |
K010208 |
02/20/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K003963 |
02/28/2001 |
DIMENSION PSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K003419 |
02/14/2001 |
RCRP FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIETRAK |
K003870 |
02/20/2001 |
THROMBOREL S |
DADE BEHRING, INC. |
REBECCA S AYASH |
K013423 |
12/12/2001 |
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K013246 |
12/11/2001 |
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 |
DATEX-OHMEDA |
JOEL KENT |
K001003 |
12/10/2001 |
Z-NET |
DEMITE LIMITED |
WILLIAM H.E. VON OEHSEN |
K011958 |
12/04/2001 |
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT |
DENKA SEIKEN'S |
SEIYA SATO |
K013430 |
12/17/2001 |
ACE BIO WIN TIBIAL NAILING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K003800 |
02/09/2001 |
AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K013563 |
12/27/2001 |
LONG TROCHANTERIC NAIL SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K013352 |
12/17/2001 |
SUMMIT CEMENTED HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K010025 |
02/22/2001 |
ELECTRICATOR MODEL 26000 |
DERMATOLOGIC LAB & SUPPLY, INC. |
DEBORAH GRAFELMAN |
K013880 |
12/07/2001 |
DAYLITE XENON LIGHT SOURCES |
DESIGNS FOR VISION, INC. |
AMY GRUMET-AVALLONE |
K013178 |
12/18/2001 |
DC-UIBC-CO2-CAL, MODEL SE-153 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K004002 |
02/14/2001 |
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K003597 |
02/05/2001 |
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K003767 |
02/12/2001 |
ASSERACHROM HPIA TEST KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B LE |
K002756 |
02/23/2001 |
EASE-A-CULT |
DIAGNOSTICA, INC. |
YOLANDA SMITH |
K013628 |
12/21/2001 |
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K013850 |
12/21/2001 |
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
K013915 |
12/27/2001 |
D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER |
DIDECO S.P.A. |
SHAWN RIEDEL |
K013449 |
12/19/2001 |
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
ELAD MAGAL |
K003977 |
02/15/2001 |
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET |
DISETRONIC MEDICAL SYSTEMS AG |
DAVID E CHADWICK |
K013786 |
12/17/2001 |
DRG ORTHOHEX SS BONE SCREW |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
K013271 |
12/13/2001 |
DXS DIGITAL X-RAY SYSTEM |
DOUGLAS C. YOON, DDS |
DOUGLAS C YOON |
K010793 |
12/20/2001 |
OXYLOG 1000, MODEL 2M86840 |
DRAGER MEDIZINTECHNIK GMBH |
JAMES J BRENNAN |
K012390 |
12/18/2001 |
NO STEP ON SITE DEUG TEST CUP |
DRUG FREE ENTERPRISES |
PERRY RUCKER |
K002877 |
02/05/2001 |
MICTEC ENDOSCOPES AND ACCESSORIES |
DUFNER INSTRUMENTE GMBH |
DAGMAR MASER |
K010386 |
02/27/2001 |
DUO-DENT DENTAL IMPLANT |
DUO-DENT DENTAL IMPLANT SYSTEMS LLC. |
MICHAEL H VOVOLKA |
K013686 |
12/07/2001 |
KODAK DIRECTVIEW TABLETOP CASSETTE |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
K010179 |
02/09/2001 |
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K013739 |
12/13/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K003529 |
02/12/2001 |
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS |
EDAP TECHNOMED, INC. |
Scott J Mindrebo |
K010526 |
12/13/2001 |
MODIFICATION TO THE GRIP |
ELCARE INNOVATIONS, INC. |
ELROY T CANTRELL |
K013861 |
12/06/2001 |
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE |
ELEKTA INSTRUMENT AB |
CAROL PATTERSON |
K003324 |
12/06/2001 |
PLASMA SPRAYED SHOULDER |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
K003615 |
02/01/2001 |
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
BRUCE G PIEKARSKI |
K013493 |
12/13/2001 |
INDIGO OPTIMA LASER SYSTEM |
ETHICON ENDO-SURGERY, INC. |
LINDA HILL |
K013413 |
12/03/2001 |
MICROMARK II TISSUE MARKER,MODEL C1535 |
ETHICON ENDO-SURGERY, INC. |
GEORGIA C ABERNATHY |
K003648 |
02/23/2001 |
FREEDLAND TENSION SYSTEM |
ETZEM TECHNOLOGIES, INC. |
AHAVA SHEIN |
K013226 |
12/20/2001 |
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT |
EVENFLO COMPANY, INC. |
MATTHEW G MCCARTY |
K010081 |
02/05/2001 |
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS |
EXACTECH, INC. |
Lisa Simpson |
K000943 |
02/08/2001 |
CEMEX SYSTEM GUN APPLICATION VERSION |
EXACTECH, INC. |
GARY J MILLER |
K010120 |
02/09/2001 |
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S |
EXACTECH, INC. |
GARY J MILLER |
K013211 |
12/05/2001 |
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS |
EXACTECH, INC. |
ROBERT PAXSON |
K010150 |
02/09/2001 |
64 CHANNEL EEG / MODEL NUMBER EX-NW-64 |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010091 |
02/01/2001 |
EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K003627 |
02/08/2001 |
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET |
EXELINT INTERNATIONAL CO. |
ARMAND HAMID |
K013037 |
12/07/2001 |
EXCEL A.V FISUTAL NEEDLE SET |
EXELINT INTL. CO. |
ARMAND HAMID |
K003644 |
02/01/2001 |
EYETECT TREMOR MONITOR UNIT (TMU) |
EYETECT, L.L.C. |
REBECCA M CUETO |
K003665 |
02/23/2001 |
FADASSI MEDICAL FM-1 NO BLENDER |
FADASIS MEDICAL, INC. |
RAYMOND RIDDLE |
K013256 |
12/07/2001 |
BI-3M NEEDLE-FREE INJECTOR SYSTEM |
FELTON INTERNATIONAL, INC. |
ALAN FELTON |
K003540 |
02/09/2001 |
(DISPOSABLE) VAGINAL SPECULUM |
FEMINICA, INC. |
DENIS H DUBOIS |
K003776 |
02/23/2001 |
MICROTARGETING DRIVE SYSTEM |
FHC, INC. |
FREDERICK HAER |
K014024 |
12/18/2001 |
MODIFICATION TO ALPHA DX SYSTEM |
FIRST MEDICAL, INC. |
GREG HOLLAND |
K013445 |
12/26/2001 |
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES |
FLORIDA OPTICAL ENGINEERING, INC. |
RICHARD A GRIFFIN |
K011939 |
12/27/2001 |
FOTONA DUALIS, FOTONA DUALIS PLUS |
FOTONA D.D. |
MOJCA VALJAVEC |
K013438 |
12/20/2001 |
FRIALIT-2 ESTHETICBASE ABUTMENT |
FRIADENT GMBH |
CAROL PATTERSON |
K013218 |
12/20/2001 |
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JOSEPH M AZARY |
K013273 |
12/20/2001 |
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE |
FUKUDA DENSHI USA, INC. |
LARRY WALKER |
K003946 |
02/27/2001 |
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K010336 |
02/16/2001 |
ADVANTAGE WINDOWS CT/PET FUSION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K002596 |
02/15/2001 |
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 |
GEBAUER CO. |
DENISE E SPELLMAN |
K014058 |
12/21/2001 |
ENTEGRA PE PERSONAL DIGITAL ASSISTANT |
GENERAL ELECTRIC MEDICAL SYSTEMS |
D. DUERSTELER |
K012660 |
12/20/2001 |
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES |
GIMMI GMBH |
DAGMAR MASER |
K003807 |
02/22/2001 |
CYSTOSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K003806 |
02/22/2001 |
URETEROSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K013446 |
12/20/2001 |
GLUSITE, MODEL GLU002 |
GLUSTITCH, INC. |
DON BLACKLOCK |
K012258 |
12/03/2001 |
COMPANION MODEL 221, 321, 421 |
GOLDEN TECHNOLOGIES, INC. |
FRED KIWAK |
K003495 |
02/07/2001 |
ANCURE LLIAC BALLOON CATHETER |
GUIDANT CARDIAC AND VASCULAR SURGERY |
JACQUELINE J JACKSON |
K013092 |
12/13/2001 |
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
JENNIFER P RIGGS |
K013638 |
12/04/2001 |
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER |
GUIDANT CORP. |
NANCY E RALSTON |
K003922 |
02/15/2001 |
NITRILE EXAMINATION GLOVES (POWERED) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K003985 |
02/09/2001 |
POWDERFREE NITRILE PATIENT EXMINATION GLOVE |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K013069 |
12/12/2001 |
BIOSPEED |
H.S. HOSPITAL SERVICES S.P.A. |
LUCIO IMPROTA |
K013070 |
12/12/2001 |
JAMSHIDI BIOPSY NEEDLE |
H.S. HOSPITAL SERVICES S.P.A. |
LUCIO IMPROTA |
K013071 |
12/12/2001 |
SECURCUT ASPIRATION BIOPSY NEEDLE |
H.S. HOSPITAL SERVICES S.P.A. |
LUCIO IMPROTA |
K002827 |
02/28/2001 |
MAC ACUPUNCTURE NEEDLE |
HAENGLIM SEOWON CORP. |
YUN CHOL CHO |
K013424 |
12/20/2001 |
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
K003649 |
02/23/2001 |
TRITON HIP SYSTEM |
HAYES MEDICAL, INC. |
WILLIAM J GRIFFIN |
K003507 |
02/21/2001 |
MEDRELIEF |
HEALTHONICS, INC. |
T. WHIT ATHEY |
K013466 |
12/21/2001 |
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 |
HELENA LABORATORIES |
PATRICIA FRANKS |
K012583 |
12/11/2001 |
ACUGLIDE BRAND ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
YI FEN CHANG |
K003915 |
02/15/2001 |
ACCUFUSER; ACCUFUSER PLUS |
HELPTECHNOLOGIES |
ROBERT J BARD |
K003930 |
02/01/2001 |
FLEXTIME MAGNUM 360 |
HERAEUS KULZER, INC. |
CHERYL ZIMMERMAN |
K004008 |
12/13/2001 |
STRESS GUARD, MODEL HERDEV1 |
HERBO MEDEX INTERNATIONAL, INC. |
RICHARD KEEN |
K001988 |
02/05/2001 |
MODULAR |
HEYER AMERICA, INC. |
ART WARD |
K013141 |
12/19/2001 |
MICROGYN PLUS STIMULATION DEVICE |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K010189 |
02/12/2001 |
VORTEX ACCESS SYSTEM |
HORIZON MEDICAL PRODUCTS, INC. |
PENNY M NORTHCUTT |
K010075 |
02/14/2001 |
TEKNIQUE |
HOVEROUND CORP. |
TONY DIGIOVANNI |
K013772 |
12/03/2001 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
K001147 |
02/15/2001 |
ENHANCED POLYETHYLENE KNEE PROSTHESES |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
K013688 |
12/05/2001 |
MODIFICATION TO XIA SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K013676 |
12/05/2001 |
TRIDENT HEMISPHERICAL ACETABULAR SHELLS |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K013475 |
12/20/2001 |
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
K013823 |
12/19/2001 |
XIA SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K012199 |
12/19/2001 |
DIGICAP |
HUMANA USA, INC. |
H.N. DUNNING |
K012501 |
12/11/2001 |
H.M.T. ACUPUNCTURE NEEDLE |
HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. |
GEOFFREY HSU |
K003840 |
02/01/2001 |
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES |
I.C. MEDICAL, INC. |
CRAIG HARSHMAN |
K013060 |
12/10/2001 |
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES |
ICS MEDICAL |
ROBERT M SIMENSON |
K010166 |
12/03/2001 |
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
JULIE POWELL |
K013570 |
12/17/2001 |
OSSEOTITE DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUELYN A HUGHES |
K004047 |
12/18/2001 |
HOME-AWAY SYSTEM |
IN-X CORP. |
CHARLIE HENRY |
K003854 |
02/05/2001 |
INTRAVASCULAR ADMINISTRATION SET |
INFUSION DEVICES, INC. |
PAUL E DRYDEN |
K013333 |
12/07/2001 |
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM |
INNOVATIVE GLOVES CO; LTD |
RAJEEV K SOOD |
K013798 |
12/19/2001 |
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
K003338 |
02/07/2001 |
BIO-EYE II ORBITAL IMPLANT |
INTEGRATED ORBITAL IMPLANTS, INC. |
FLOYD G LARSON |
K010219 |
02/21/2001 |
CHALLENGER DIRECT COMPOSITE |
INTERNATIONAL DENTAL RESEARCH |
PAMELA PAPINEAU |
K003892 |
02/20/2001 |
TOTAL BILIRUBIN REAGENT |
INTERSECT SYSTEMS, INC. |
JOAN CATHEY |
K013516 |
12/13/2001 |
INVACARE ELEVATING SEAT OPTION ESS6 |
INVACARE CORP. |
RAE A FARROW |
K010135 |
02/16/2001 |
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 |
INVACARE CORP. |
RAE A FARROW |
K003646 |
02/22/2001 |
SUTUREGROOVE WEIGHT SIZING SET |
IOP, INC. |
JASON MALECKA |
K010304 |
02/12/2001 |
MXR-2000 MOBILE X-RAY UNIT |
IROM IMAGING, INC. |
ROMAN KRYSTYNIAK |
K003882 |
02/21/2001 |
NUCAMMA BI90 |
IS2 RESEARCH, INC. |
VICTOR WOODBURN |
K001852 |
02/21/2001 |
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
AHAVA STEIN |
K003293 |
02/06/2001 |
EXCITE DSC |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K010250 |
02/28/2001 |
TETRIC CERAM HB |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K013017 |
12/06/2001 |
MEDIGROUP KEY TUBE |
JANIN GROUP, INC. |
JOHN A NAVIS |
K013698 |
12/21/2001 |
AST (SGOT) |
JAS Diagnostics, Inc. |
David Johnston |
K003912 |
02/21/2001 |
PHOSPHORUS REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K003829 |
02/12/2001 |
TOTAL BILIRUBIN |
JAS Diagnostics, Inc. |
David Johnston |
K010044 |
02/09/2001 |
COSMIC |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K010231 |
02/09/2001 |
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE |
JK GLOVES SDN. BHD. |
TAI SAI LEONG |
K993229 |
02/02/2001 |
ANALGESIC PULSER, MODEL AP-439 |
JOHARI ELECTRO-TECH CO. |
NISHA JOHARI |
K013939 |
12/14/2001 |
JOSTRA FLOWPROBE FP-32E |
JOSTRA AG |
KATHLEEN JOHNSON |
K013401 |
12/14/2001 |
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 |
K-SYSTEMS, KIVEX BIOTEC LTD. |
JACOB MOLLENBACH |
K004037 |
02/02/2001 |
X-RAY SYSTEM XR-MX |
KARL STORZ ENDOSCOPY |
JENNIFER S PORTUGAL |
K010340 |
02/13/2001 |
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI |
KARL STORZ LITHOTRIPSY-AMERICA, INC. |
MARIKA ANDERSON |
K011691 |
12/27/2001 |
KIMSTIM AURICULAR ELECTRODE |
KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. |
DONALD F GRABARZ |
K003347 |
02/23/2001 |
ORTHOPILOT |
KINAMED, INC. |
JOEL SLOMOFF |
K013537 |
12/07/2001 |
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
KOON SENG SDN.BHD |
LIM WENG HENG |
K010246 |
02/14/2001 |
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A |
KYPHON, INC. |
KAREN TALMADGE |
K011960 |
12/21/2001 |
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) |
LARES RESEARCH, INC. |
THOMAS H LOUISELL |
K003760 |
02/06/2001 |
TAI-CHI ACUPUNCTURE NEEDLES |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
DEN000008 |
02/16/2001 |
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) |
LIFE TECHNOLOGIES, INC. |
JONATHAN S KAHAN, ESQ. |
K001329 |
02/14/2001 |
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET |
LIFEMED OF CALIFORNIA |
PATRICIA BRINKER |
K013553 |
12/19/2001 |
PRE-LOADED ULTRAFIX RC |
LINVATEC CORP. |
LAURA D SENEFF |
K011197 |
12/14/2001 |
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM |
LUMENIS |
C. ROBERT PAYNE JR. |
K002688 |
02/01/2001 |
PERSONAL GLUCOSE CONTROL CHARTING SYSTEM |
LXN CORP. |
SANDRA F SELVAGGI |
K012025 |
12/03/2001 |
MACROPORE SURGIWRAP (TS) |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
K000581 |
02/23/2001 |
MAEDA NEW NEEDLE DISPOSABLE |
MAEDA TOYOKICHI SHOTEN |
E.J. Smith |
K003075 |
12/11/2001 |
KNIGHTSTAR 330 VENTILATOR |
MALLINCKRODT, INC. |
ANTHONY MULLIN |
K013792 |
12/11/2001 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
K012186 |
12/07/2001 |
MASTER & FRANK SURGICAL GOWNS (STERILE) |
MASTER & FRANK ENT. CO., LTD. |
JENNIFER REICH |
K010069 |
02/15/2001 |
DURABOND NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
K011845 |
12/04/2001 |
MILLCOMP |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
K010297 |
02/16/2001 |
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) |
MAXXIM MEDICAL |
WUNAN HUANG |
K013244 |
12/07/2001 |
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE |
MED GEN, INC. |
THEDORE BARASH |
K002515 |
02/22/2001 |
MEDLOGICS ML 4000, MODEL 4000 |
MED-LOGICS, INC. |
GARY MOCNIK |
K013225 |
12/26/2001 |
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE |
MEDAFOR, INC. |
PHILIP B JARVI |
K003672 |
02/22/2001 |
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE |
MEDGE PLATFORMS, INC. |
GUSTAVO EDUARDO ABELLA |
K002666 |
02/27/2001 |
DIAMOND ALOE VERA, STERILE |
MEDI-TECH INTL. CORP. |
HERBERT A PERRY |
K002407 |
02/02/2001 |
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER |
MEDICA CORP. |
Photios Makris |
K010111 |
02/28/2001 |
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
K013734 |
12/07/2001 |
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
K013995 |
12/21/2001 |
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
K010021 |
02/23/2001 |
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S |
MEDICAL COMPONENTS, INC. |
FLORENCE A CAIKOSKI |
K002699 |
02/15/2001 |
PARIETEX COMPOSITE (PCO) MESH |
MEDICAL DEVICE CONSULTANTS, INC. |
MARY MCNAMARA-CULLINANE |
K002280 |
02/05/2001 |
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 |
MEDICAL DEVICES, INC. |
WARREN R WALTERS |
K003489 |
02/02/2001 |
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
DAVID GLOVER |
K013098 |
12/07/2001 |
KIMAX REMOTE VIEWING STATION |
MEDICAL METRICS, INC. |
ANN TUNSTALL |
K010187 |
02/14/2001 |
KIMAX, MODEL 1024 |
MEDICAL METRICS, INC. |
ANN TUNSTALL |
K011202 |
12/31/2001 |
MSI BIPOLAR SHEATH |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA |
K002079 |
02/22/2001 |
MULTI-FUNCTION DEFIBRILLATION ELECTRODE |
MEDICOTEST A/S |
EMALEE G MURPHY |
K003332 |
02/21/2001 |
MEDITHERM MED2000 |
MEDITHERM, INC. |
PETER LEANDO |
K003699 |
02/27/2001 |
MEDIVISION IGS SYSTEM |
MEDIVISION (U.S.A.), INC. |
SANDRA WILLIAMSON |
K003755 |
02/16/2001 |
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K013761 |
12/06/2001 |
MEDLINE EXCEL RECLINCER WHEELCHAIR |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
K013815 |
12/13/2001 |
MEDRAD QWIK-FIT SYRINGE |
MEDRAD, INC. |
FRANK W PELC III |
K010138 |
02/14/2001 |
PROFILE II ER |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K013013 |
12/04/2001 |
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
ROGER W BRINK |
K000776 |
02/07/2001 |
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
JAMES BALUN |
K010130 |
02/07/2001 |
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
K013063 |
12/11/2001 |
GRIP LOCK ANCHOR, MODEL 411374 |
MEDTRONIC NEUROLOGICAL |
MONAYA LEE |
K013000 |
12/05/2001 |
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 |
MEDTRONIC NEUROSURGERY |
JANET MCAULEY |
K011144 |
12/03/2001 |
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR |
MEDTRONIC PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
K003914 |
02/22/2001 |
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
K010249 |
02/23/2001 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K013663 |
12/05/2001 |
CEMENT RESTRICTOR |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K013829 |
12/19/2001 |
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICK W TREHARNE |
K014076 |
12/27/2001 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K011406 |
12/27/2001 |
SPINAL MESH SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K003718 |
02/14/2001 |
TITANIUM CEMENT RESTRICTOR (TCR) |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K003667 |
02/14/2001 |
REVEAL PLUS INSERTABLE LOOP RECORDER |
MEDTRONIC VASCULAR |
STACEY P WESSMAN |
K003535 |
02/08/2001 |
STYLET KIT, MODELS 6254,6282,6293 |
MEDTRONIC VASCULAR |
KAREN CLEMENT |
K011500 |
12/03/2001 |
MENTOR CONTOUR PROFILE TISSUE EXPANDER |
MENTOR CORP. |
DONNA CRAWFORD |
K013788 |
12/11/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 |
MERITS HEALTH PRODUCTS CO., LTD. |
WINSTON ANDERSON |
K013505 |
12/19/2001 |
AUROFLUID PLUS |
METALOR TECHNOLOGIES USA |
BRUCE BARTON |
K010102 |
02/09/2001 |
SONIC MODEL SO-300 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
K003260 |
02/22/2001 |
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
K010004 |
02/13/2001 |
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 |
MICRO THERAPEUTICS, INC. |
EBEN GORDEN |
K003695 |
02/14/2001 |
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES |
MICRO-MEDICAL DEVICES, INC. |
GEORGE COLEMAN |
K002113 |
12/04/2001 |
CTXA HIP; CTXA; QCT PRO CTXA HIP |
MINDWAYS SOFTWARE, INC. |
CHRISTOPHER CANN |
K013040 |
12/07/2001 |
LIGHT SABER INTRODUCER NEEDLE |
MINRAD, INC. |
HOWARD M HOLSTEIN |
K002406 |
02/15/2001 |
MITEK 2GII MENISCAL REPAIR SYSTEM |
MITEK PRODUCTS |
CAROL CHAOUI |
K013047 |
12/06/2001 |
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM |
MOJCA VALIJAVEC |
MOJCA VALJAVEC |
K010140 |
02/22/2001 |
HRH-127 HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K003655 |
02/02/2001 |
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K012088 |
12/18/2001 |
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT |
NASTECH PHARMACEUTICAL COMPANY, INC. |
PETER C APRILE |
K013024 |
12/04/2001 |
SELECTIVA GUIDEWIRE |
NEO METRICS, INC. |
GENE CHAMPEAU |
K001781 |
02/05/2001 |
CURRY MULTIMODAL NEUROIMAGING SOFTWARE |
NEUROSOFT, INC. |
DAVID B JONES |
K002042 |
02/01/2001 |
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 |
NEW ENGLAND MEDICAL CORP. |
STEVEN FODOR |
K013992 |
12/13/2001 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
ROBERT SCHMIDT |
K013419 |
12/20/2001 |
NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
K002068 |
02/08/2001 |
ORG-9200A |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
K013293 |
12/14/2001 |
NIPRO HYPODERMIC NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
K013287 |
12/03/2001 |
NIPRO SAFELET CATH |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
K993600 |
02/05/2001 |
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 |
NISHA COMMUNICATION INDUSTRIES |
NISHA JOHARI |
K013036 |
12/07/2001 |
NOMOS MOTORIZED CRANE II |
NOMOS CORP. |
FRANCIS X DOBSCHA |
K013436 |
12/21/2001 |
NORMATEC PCD |
NORMATEC, INC. |
JONATHAN S KAHAN |
K001965 |
02/02/2001 |
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS |
NORTH AMERICAN MEDICAL PRODUCTS, INC. |
ARTHUR GIANAKOS |
K001916 |
02/16/2001 |
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX |
NOVARTIS NUTRITION CORP. |
SHARON MARTIN |
K002429 |
02/02/2001 |
SELECT SEED I-125 |
NUCLETRON CORP. |
ROBERT APPLEBAUM |
K004000 |
02/21/2001 |
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT |
OCU-EASE OPTICAL PRODUCTS, INC. |
CHARLES R VERMETTE |
K003996 |
02/21/2001 |
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR |
OCU-EASE OPTICAL PRODUCTS, INC. |
CHARLES R VERMETTE |
K013377 |
12/20/2001 |
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
RICHARD LIPPMAN |
K010850 |
12/17/2001 |
POLESTAR N-10 |
ODIN MEDICAL TECHNOLOGIES LTD. |
ADI ICKOWICZ |
K010388 |
12/11/2001 |
SONDREX P.A.L. SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K013066 |
12/11/2001 |
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K001744 |
02/27/2001 |
OLYMPUS ENDOSCOPIC LIGATION DEVICE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K013591 |
12/26/2001 |
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K003522 |
02/13/2001 |
SALUTE |
ONUX MEDICAL, INC. |
GREGORY E SANCOFF |
K013110 |
12/19/2001 |
ANISEIKONIA INSPECTOR |
OPTICAL DIAGNOSTICS, INC. |
JOYCE DE WIT |
K003704 |
02/05/2001 |
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) |
OPTOVENT AB |
CLAES RYMOND |
K003482 |
02/01/2001 |
PROCLUDE-SENSITIVE |
ORTEK THERAPEUTICS, INC. |
JULES T MITCHEL |
K013900 |
12/21/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE A SHULMAN |
K011887 |
12/27/2001 |
AVALON CUP SYSTEM |
ORTHOPEDIC SOURCE INC. |
STEVEN L MANDELL |
K013094 |
12/14/2001 |
ORTHOSONIX ENERGEX |
ORTHOSONIX, INC. |
RUSSELL PAGANO |
K012762 |
12/11/2001 |
MJS POSTERIOR STABILIZED KNEE SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K013371 |
12/21/2001 |
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR |
K012588 |
12/10/2001 |
OXOID PYLORI TEST KIT, MODEL DR0130M |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K013028 |
12/06/2001 |
PALOMAR SLP 1000 |
PALOMAR MEDICAL PRODUCTS, INC. |
Marcy Moore |
K010001 |
02/05/2001 |
LIVESURE THC SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K010109 |
02/28/2001 |
FLUOROPERM 151-OK, PARAGON HDS 100-OK |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K003102 |
02/27/2001 |
PARE ENDOSCOPIC SUTURING SYSTEM |
PARE SURGICAL, INC. |
RICHARD P FLEENOR |
K003737 |
02/01/2001 |
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHANG |
K003858 |
02/12/2001 |
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 |
PHAMATECH |
CARL A MONGIOVI |
K013410 |
12/06/2001 |
AT HOME DRUG TEST, MODEL 9064 |
PHAMATECH INC. |
CARL MONGIOVI |
K013412 |
12/06/2001 |
AT HOME DRUG TEST, MODEL 9069 |
PHAMATECH INC. |
CARL MONGIOVI |
K013409 |
12/06/2001 |
AT HOME DRUG TEST, MODEL 9074 |
PHAMATECH INC. |
CARL MONGIOVI |
K013408 |
12/06/2001 |
AT HOME DRUG TEST, MODEL 9079 |
PHAMATECH INC. |
CARL MONGIOVI |
K013407 |
12/06/2001 |
AT HOME DRUG TEST, MODEL 9084 |
PHAMATECH INC. |
CARL MONGIOVI |
K013344 |
12/11/2001 |
INTERA I/T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
PETER ALTMAN |
K003853 |
02/13/2001 |
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE PRASCHAN |
K003437 |
02/02/2001 |
ODYSSEY LX, MODEL 211320 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
RONALD J MARTONE |
K013624 |
12/03/2001 |
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
DENISE HALEY |
K013451 |
12/18/2001 |
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
K003496 |
02/08/2001 |
CANNULATED SCREW SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
AMY H MOMMAERTS |
K013340 |
12/20/2001 |
RT-PLUS KNEE ADDITIONAL COMPONENTS |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K003932 |
02/16/2001 |
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY |
POLYMER TECHNOLOGY |
NANCY ABRAHAM |
K003933 |
02/16/2001 |
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY |
POLYMER TECHNOLOGY |
NANCY ABRAHAM |
K014099 |
12/21/2001 |
BIOSCANNER PLUS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K012108 |
12/19/2001 |
MEDPOR COATED TEAR DRAIN |
POREX SURGICAL, INC. |
HOWARD MERCER |
K013172 |
12/20/2001 |
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL |
PORGES S.A. |
BERNARD ISMAEL |
K013708 |
12/10/2001 |
REFERENCE CHECK, CATALOG NUMBER-RCN-10 |
PRECISION BIOLOGIC |
STEPHEN L DUFF |
K003843 |
02/08/2001 |
ENVIVE MINIFORMS |
PROCTER & GAMBLE CO. |
KATHLEEN C BLIEZNER |
K013411 |
12/12/2001 |
PULPDENT CAVITY PREPARATION IV |
PULPDENT CORP. |
KENNETH J BERK |
K013358 |
12/13/2001 |
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM |
PULSE METRIC, INC. |
ROBERT DUFFY |
K010077 |
02/28/2001 |
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES |
PWA INDUSTRIES SDN. BHD. |
K. KARUNAKARAN |
K013943 |
12/18/2001 |
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K013660 |
12/05/2001 |
GENETRA |
RADIOMED CORPORATION |
GORDON ROBERTS |
K013661 |
12/03/2001 |
XPLAN 2.2 WITH THE BODY SYSTEM |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
K011393 |
12/04/2001 |
RANDOX PHENYTOIN |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K002585 |
02/05/2001 |
RANDOX TRANSFERRIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K010194 |
02/15/2001 |
COMFOR-CLINER |
RECLINER CARE, INC. |
MARK D BROWN |
K013328 |
12/03/2001 |
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 |
REMINGTON PRODUCTS COMPANY, L.L.C. |
PAMELA J FURMAN |
K013200 |
12/14/2001 |
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 |
RENNELS MEDICAL CORP. |
DAVID LEE |
K013027 |
12/06/2001 |
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 |
RESPIRONICS HEALTHSCAN, INC. |
SUSAN D GOLDSTEIN-FALK |
K012323 |
12/20/2001 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
K003499 |
02/09/2001 |
REMVIEW SLEEP RECORDER, MODEL 320 |
RESPIRONICS, INC. |
DAVID J VANELLA |
K012040 |
12/18/2001 |
RAMP MYOGLOBIN ASSAY |
RESPONSE BIOMEDICAL CORP. |
WILLIAM J RADVAK |
K013367 |
12/13/2001 |
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
K993535 |
12/07/2001 |
METAPAK MULTI-PURPOSE INSTRUMENT TRAY |
RILEY MEDICAL, INC. |
MARY MCNAMARA-CULLINANE |
K013482 |
12/21/2001 |
ABUSCREEN ONLINE OPIATES 300 / 2000 |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
K012324 |
12/05/2001 |
ACCU-CHEK ACTIVE TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K003865 |
02/28/2001 |
COBAS INTEGRA AMPHETAMINES |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
K010237 |
02/14/2001 |
ELECSYS HCG+B CALCHECK |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
K010190 |
02/08/2001 |
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 |
ROSSMAX INTERNATIONL LTD. |
MICHAEL YEH |
K010068 |
02/08/2001 |
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM |
RUSCH INTL. |
KARENANN J BROZOWSKI |
K010012 |
02/14/2001 |
LC PROVIFILL |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
K002712 |
02/08/2001 |
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F |
S.A.A.T., LTD. |
SHOSHANA FRIEDMAN |
K013379 |
12/12/2001 |
SAS STREPALERT |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
K010502 |
02/27/2001 |
MODEL THERMO TEK QUICKCARE |
SAAT LTD. |
E. J SMITH |
K013801 |
12/13/2001 |
ULTRASAFE DENTAL INJECTION SYSTEM |
SAFETY SYRINGES, INC. |
THOMAS L HALL |
K011323 |
12/17/2001 |
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 |
SALIMETRICS LLC. |
EVE SCHWARTZ |
K013703 |
12/14/2001 |
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M |
SANYO NORTH AMERICA CORP. |
SACHI KATAOKA |
K013649 |
12/26/2001 |
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS |
SAUFLON PHARMACEUTICALS, LTD. |
LIGIA DELACRUZ |
K010559 |
12/20/2001 |
SAUFLON MULTI LENS CARE SYSTEM |
SAUFLON PHARMACEUTICALS, LTD. |
LIGIA DELACRUZ |
K013288 |
12/03/2001 |
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E |
SGMP CO., LTD. |
JANNA TUCKER |
K010095 |
02/09/2001 |
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR |
SGMP CO., LTD. |
JANNA P TUCKER |
K010247 |
02/06/2001 |
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES |
SHANGHAI CHINASTAR CORP. |
LEE HUNG TE CHIH |
K013327 |
12/14/2001 |
CTS-415 |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
K003515 |
02/12/2001 |
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 |
SHIMADZU MEDICAL SYSTEMS |
MASAAKI SHIBATA |
K003514 |
02/12/2001 |
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 |
SHIMADZU MEDICAL SYSTEMS |
MASAAKI SHIBATA |
K003130 |
02/16/2001 |
REGUTHERM 952 THERMOGRAPHIC SYSTEM |
SIE-MED, INC. |
CHARLES H KYPER |
K010925 |
12/18/2001 |
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
SIEMENS ELEMA AB |
DIANE WURZBURGER |
K003945 |
02/02/2001 |
OPDIMA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRAVEEN NADKARNI |
K010137 |
02/13/2001 |
ORBITER II CCI/SPECT ORBITER II CCI/SPECT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
RONALD NOLTE |
K013586 |
12/28/2001 |
MAGNETOM TRIO SYSTEM |
SIEMENS MEDICAL SYSTEMS, INC. |
JAMIE YIEH |
K013549 |
12/26/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
K011907 |
12/18/2001 |
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM |
SIMS LEVEL 1, INC. |
GABRIEL J MURACA, JR. |
K002201 |
02/05/2001 |
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
K013056 |
12/21/2001 |
GELCLAIR CONCENTRATED ORAL GEL |
SINCLAIR PHARMACEUTICALS, LTD. |
PRISCILLA COX |
K013659 |
12/06/2001 |
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
K013650 |
12/06/2001 |
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA M HEMEON-HEYER |
K013727 |
12/07/2001 |
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
K012378 |
12/13/2001 |
3D HUMERAL HEADS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K003566 |
02/14/2001 |
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K003572 |
02/15/2001 |
DYONICS CONTROL RF SYSTEM |
SMITH & NEPHEW, INC. |
MARK KIERAS |
K003710 |
02/02/2001 |
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K013658 |
12/05/2001 |
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K003599 |
02/15/2001 |
SMITH & NEPHEW SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
WILLIAM MCCALLUM |
K013989 |
12/19/2001 |
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
K013817 |
12/21/2001 |
GLO-SPEC |
SOL WEISS MD INC |
SOL WEISS |
K014116 |
12/20/2001 |
HAND-CARRIED ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL HOFFMAN |
K010374 |
02/21/2001 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
K013090 |
12/13/2001 |
SOPRO 67D OPERATING ROOM CAMERA |
SOPRO |
PIERRE MONTILLOT |
K003789 |
02/21/2001 |
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT |
SPECIALTY ULTRAVISION, INC. |
DEBBIE MCINTIRE |
K003526 |
02/12/2001 |
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) |
SPECIALTY ULTRAVISION, INC. |
GAROLD L EDWARDS |
K003423 |
02/22/2001 |
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 |
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. |
FRANCIS HONG |
K012268 |
12/03/2001 |
TRIMAX |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
K010282 |
02/09/2001 |
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM |
STELKAST COMPANY |
DONALD A STEVENS |
K010241 |
02/08/2001 |
PROTRACT PRESS FIT HIP STEM-HA COATED |
STELKAST COMPANY |
DONALD A STEVENS |
K013139 |
12/18/2001 |
STELLARTECH COAGULATION SYSTEM |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
K013630 |
12/05/2001 |
ISITE RADIOLOGY |
STENTOR, INC. |
GARY J ALLSEBROOK |
K002912 |
02/21/2001 |
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 |
STERINC |
TODD ABRAHAM |
K013242 |
12/13/2001 |
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM |
STERIS Corporation |
ROBERT H MCCALL |
K003533 |
02/07/2001 |
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
K013502 |
12/03/2001 |
SIMPLICITY CLASSIC WING QD INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K013767 |
12/12/2001 |
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K003792 |
02/21/2001 |
STRYKER HEATED INSUFFLATOR TUBE SET |
STRYKER CORP. |
MICHAEL BAYCURA |
K014091 |
12/31/2001 |
STRYKER PAINPUMP |
STRYKER CORP. |
NICOLE PETTY |
K012380 |
12/03/2001 |
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY |
STRYKER LEIBINGER |
ROBIN L ROWE |
K013935 |
12/13/2001 |
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K003801 |
02/28/2001 |
ANATOMICAL PRESS-FIT HUMERAL STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K013031 |
12/07/2001 |
MOST OPTIONS SYSTEM |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
K010198 |
02/23/2001 |
STERILE POWDERED LATEX SURGEON GLOVES |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
K003436 |
02/02/2001 |
SURGI-VISION GUIDEWIRE COIL |
SURGI-VISION, INC. |
NANCY E TALOR |
K013132 |
12/20/2001 |
SIGN IM NAIL |
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
DOUG DONNELLY |
K013337 |
12/13/2001 |
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI |
SURGIN INC |
DON HAAR |
K010214 |
02/22/2001 |
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 |
SURVIVALINK CORP. |
Sew-Wah Tay |
K003640 |
02/22/2001 |
MINIENDO III |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSELL |
K003650 |
02/15/2001 |
PERMLASTIC 3 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K012415 |
12/18/2001 |
AURIS AEP |
SYNAPSYS, INC. |
JULIEN CHAUSSY |
K010030 |
02/14/2001 |
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR |
SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. |
JAMES F GODFREY |
K013527 |
12/21/2001 |
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
K011897 |
12/20/2001 |
NORIAN SRS BONE VOID FILLER |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K003786 |
02/27/2001 |
SMF RESORBABLE MESHES AND SHEETS |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K010121 |
02/09/2001 |
STERILE BUTTON PLATE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K012945 |
12/03/2001 |
SYNTHES 2.4 MM CANNULATED SCREW |
SYNTHES (USA) |
MATTHEW M HULL |
K013044 |
12/03/2001 |
SYNTHES 3.9 MM PELVIC SCREWS |
SYNTHES (USA) |
MATTHEW M HULL |
K003700 |
02/20/2001 |
SYNTHES HAMSTRING LOOP |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K013248 |
12/19/2001 |
SYNTHES LCP DISTAL TIBIA PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
K003743 |
02/09/2001 |
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K010094 |
02/15/2001 |
A & I WHEELCHAIRS |
TAIWAN AN I CO.,LTD. |
ANI HWONG |
K010007 |
02/22/2001 |
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP |
TAUT, INC. |
RONALD KENSETH |
K003703 |
02/22/2001 |
TAUT-INSUFFLATION NEEDLE |
TAUT, INC. |
RONALD KENSETH |
K013323 |
12/05/2001 |
TCI-31 LIFELONG OVULATION TESTER |
TCI NEW YORK |
Erika B Ammirati |
K991259 |
02/21/2001 |
TE ME NA EPIDURAL CATHETER |
TE ME NA S.A.R.L. |
JOE HARMS |
K013317 |
12/17/2001 |
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
TEKMEDIC (M) SDN BHD |
KOK-KEE HON |
K003591 |
02/14/2001 |
TENSCARE, MODEL TENS XL-2 |
TENS CARE LTD. |
BERNARD J TREMAINE |
K003629 |
02/22/2001 |
MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 |
TERRAY CORP. |
STEVE WANG |
K003604 |
02/07/2001 |
ADAPTERS WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K010443 |
12/11/2001 |
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K003425 |
02/01/2001 |
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
K003571 |
02/12/2001 |
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
K013849 |
12/03/2001 |
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS |
TETRAD CORP. |
CHARLES F HOTTINGER |
K004019 |
02/15/2001 |
ANA EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K010148 |
02/23/2001 |
ENA SCREEN EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K003669 |
02/01/2001 |
KAPPA IMMAGE FREELITE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K003671 |
02/01/2001 |
LAMBDA IMMAGE FREELITE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K002896 |
02/21/2001 |
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING |
THE WESTAIM CORP. |
STEVEN CHARTIER |
K004048 |
02/06/2001 |
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
K010267 |
02/27/2001 |
PALFIQUE ESTELITE LV CLEAR |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K003936 |
02/14/2001 |
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
K012820 |
12/14/2001 |
AIA-PACK CTNI 2ND-GEN ASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
K002045 |
02/16/2001 |
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
TOTAL WATER TREATMENT SYSTEMS, INC. |
KENNETH J CLARK |
K013580 |
12/12/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K013925 |
12/21/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K003868 |
02/27/2001 |
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K003834 |
02/23/2001 |
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K013903 |
12/17/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 |
TRIAD MEDICAL, INC. |
RITA GIEBEL |
K013086 |
12/13/2001 |
WET LIGHT PERSONAL MOISTURIZER |
TRIGG LABORATORIES, INC. |
W. PATRICK NOONAN |
K012514 |
12/21/2001 |
DIGIPAN / DPI |
TROPHY RADIOLOGIE |
MARIE-PIERRE LABAT-CAMY |
K003470 |
02/20/2001 |
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 |
TUTTNAUER CO. LTD. |
MARK YACURA |
K993856 |
02/09/2001 |
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
K013556 |
12/31/2001 |
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE |
TYCO HEALTHCARE |
DAVID A OLSON |
K003383 |
02/06/2001 |
PALMLIGHT |
ULTRADENT PRODUCTS, INC. |
MARKUS R GEE |
K012071 |
12/03/2001 |
ENT LASERVISION |
UNION MEDICAL USA |
ANNIE VELEZ |
K013860 |
12/19/2001 |
AUTO SUTURE SURGICAL STAPLES |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K013890 |
12/11/2001 |
SURGICAL DYNAMICS MENISCAL STAPLE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER SCHUCK |
K010098 |
02/01/2001 |
MODIFICATION TO CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
K013528 |
12/13/2001 |
CRYSTAL 5000 PHASES ARRAY TMJ COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K011683 |
12/10/2001 |
NURVO 9000 ENDOCAVITARY COILS |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K013541 |
12/14/2001 |
SHOULDER COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K011832 |
12/21/2001 |
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
K003636 |
02/02/2001 |
PORTALVISION |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
K003719 |
02/28/2001 |
VASCULAR ARCHITECTS PERISCOPE DEVICE |
VASCULAR ARCHITECTS, INC. |
JEAN M CAILLOUETTE |
K012256 |
12/20/2001 |
GELBISH VASCULAR DILATOR |
VASCUMETRIX, LLC |
MIKE HAMMONS |
K013308 |
12/20/2001 |
VENTLAB HYPERINFLATION BAG SYSTEM |
VENTLAB CORP. |
MARGE WALLS-WALKER |
K011702 |
12/21/2001 |
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX |
VERTIS NEUROSCIENCE, INC. |
LORI GLASTETTER |
K013146 |
12/07/2001 |
VIATRONIC V3D CALCIUM SCORING |
VIATRONIX, INC. |
SUSAN D GOLDSTEIN-FALK |
K013702 |
12/27/2001 |
VICTORCH HCG TEST STRIP |
VICTORCH MEDITEK, INC. |
PIERCE LIU |
K013678 |
12/27/2001 |
VICTORCH MEDITEK'S HCG TEST CARD |
VICTORCH MEDITEK, INC. |
PIERCE LIU |
K012587 |
12/11/2001 |
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE |
VIDAMED, INC. |
YI CHEN |
K002583 |
02/13/2001 |
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM |
VIDAMED, INC. |
TOM MCGAFFIGAN |
K003510 |
02/12/2001 |
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 |
VISUALIZATION TECHNOLOGY, INC. |
NORMA LEMAY |
K003607 |
02/15/2001 |
ONYX-RAD TELEMEDICINE PACS |
VIZTEK, INC. |
JOSIP CERMIN |
K003684 |
02/23/2001 |
PERCUSSIVENEB, MODEL PN-2001 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
K002469 |
02/07/2001 |
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) |
W & H DENTALWERK BUERMOOS GMBH |
HERBERT TRASCHWANDTNER |
K013282 |
12/14/2001 |
GORE INTRODUCER SHEATH |
W. L. GORE & ASSOCIATES, INC. |
R. LARRY PRATT |
K013346 |
12/19/2001 |
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
K010228 |
02/21/2001 |
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
K003668 |
02/12/2001 |
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 |
WALLAC OY |
GUNNEL LAAKSONEN |
K003664 |
02/14/2001 |
DELFIA NEONATAL IRT KIT, MODEL A005-110 |
WALLAC OY |
GUNNEL LAAKSONEN |
K002083 |
02/12/2001 |
LORENZ RESORBABLE DISTRACTOR SYSTEM |
WALTER LORENZ SURGICAL, INC. |
STEVE HERRINGTON |
K002219 |
02/02/2001 |
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE |
WANDY RUBBER INDUSTRIAL CO., LTD |
JANIS YANG |
K002227 |
02/02/2001 |
WANDY SILICONE CONDUCTIVE RUBBER PAD |
WANDY RUBBER INDUSTRIAL CO., LTD |
JANIS YANG |
K003773 |
02/02/2001 |
CLEAN SCRAPE |
WEBB RESEARCH II, INC. |
STEVEN KRUPNICK |
K002466 |
02/16/2001 |
ACTICOAT COMPOSITE DRESSING |
WESTAIM BIOMEDICAL, INC. |
Steve Chartier |
K010059 |
02/27/2001 |
ENGPLUS |
WESTERN SYSTEMS RESEARCH, INC. |
LINDA DAVIS-O'LEARY |
K012839 |
12/31/2001 |
AUROPAL, ORDER-NO.: 2101 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD P0LZER |
K013652 |
12/21/2001 |
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K011953 |
12/21/2001 |
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K013035 |
12/07/2001 |
GUARDIAN LIMB SALVAGE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K004032 |
02/15/2001 |
PERFECTA AND EXTEND |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K013942 |
12/31/2001 |
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD H HUSSEIN |
K010099 |
02/01/2001 |
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER |
ZCV ,INC. |
JING ZHANG |
K011244 |
12/10/2001 |
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
K013991 |
12/27/2001 |
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
K003478 |
02/05/2001 |
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 |
ZIMMER, INC. |
KAREN CAIN |
K010257 |
02/28/2001 |
ZOLL M SERIES |
ZOLL MEDICAL CORP. |
PAUL DIAS |