FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K011255 |
12/20/2001 |
3D LINE STEROTACTIC HARDWARE ACCESSORIES |
3D LINE USA, INC. |
KAREN H RIGAMONTI |
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 |
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 |
K013616 |
12/19/2001 |
POLARUS CAP SCREW |
ACUMED, INC. |
SHARI JEFFERS |
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 |
K012631 |
12/06/2001 |
REPROCESSED SOFT TISSUE ABLATORS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
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 |
K012968 |
12/03/2001 |
APPLIED ACCESS SEAL |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
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 |
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 |
K012988 |
12/05/2001 |
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
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 |
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 |
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 |
K013193 |
12/21/2001 |
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE |
BIOLITEC, INC. |
CAROL J MORELLO |
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 |
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 |
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 |
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 |
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 |
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 |
K013928 |
12/03/2001 |
PAIN CARE 3200 |
BREG, INC. |
KATHLEEN BARBER |
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 |
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 |
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 |
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 |
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 |
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 |
K013878 |
12/07/2001 |
CYBERMED, INC., V-WORKS |
CYBERMED, INC. |
GARY J ALLSEBROOK |
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 |
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 |
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 |
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 |
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 |
K013686 |
12/07/2001 |
KODAK DIRECTVIEW TABLETOP CASSETTE |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
K013739 |
12/13/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
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 |
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 |
K013226 |
12/20/2001 |
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT |
EVENFLO COMPANY, INC. |
MATTHEW G MCCARTY |
K013211 |
12/05/2001 |
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS |
EXACTECH, INC. |
ROBERT PAXSON |
K013037 |
12/07/2001 |
EXCEL A.V FISUTAL NEEDLE SET |
EXELINT INTL. CO. |
ARMAND HAMID |
K013256 |
12/07/2001 |
BI-3M NEEDLE-FREE INJECTOR SYSTEM |
FELTON INTERNATIONAL, INC. |
ALAN FELTON |
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 |
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 |
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 |
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 |
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 |
K013424 |
12/20/2001 |
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
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 |
K004008 |
12/13/2001 |
STRESS GUARD, MODEL HERDEV1 |
HERBO MEDEX INTERNATIONAL, INC. |
RICHARD KEEN |
K013141 |
12/19/2001 |
MICROGYN PLUS STIMULATION DEVICE |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K013772 |
12/03/2001 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
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 |
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 |
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 |
K013516 |
12/13/2001 |
INVACARE ELEVATING SEAT OPTION ESS6 |
INVACARE CORP. |
RAE A FARROW |
K013017 |
12/06/2001 |
MEDIGROUP KEY TUBE |
JANIN GROUP, INC. |
JOHN A NAVIS |
K013698 |
12/21/2001 |
AST (SGOT) |
JAS Diagnostics, Inc. |
David Johnston |
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 |
K011691 |
12/27/2001 |
KIMSTIM AURICULAR ELECTRODE |
KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. |
DONALD F GRABARZ |
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 |
K011960 |
12/21/2001 |
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) |
LARES RESEARCH, INC. |
THOMAS H LOUISELL |
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. |
K012025 |
12/03/2001 |
MACROPORE SURGIWRAP (TS) |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
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 |
K011845 |
12/04/2001 |
MILLCOMP |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
K013244 |
12/07/2001 |
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE |
MED GEN, INC. |
THEDORE BARASH |
K013225 |
12/26/2001 |
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE |
MEDAFOR, INC. |
PHILIP B JARVI |
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 |
K013098 |
12/07/2001 |
KIMAX REMOTE VIEWING STATION |
MEDICAL METRICS, INC. |
ANN TUNSTALL |
K011202 |
12/31/2001 |
MSI BIPOLAR SHEATH |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA |
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 |
K013013 |
12/04/2001 |
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
ROGER W BRINK |
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 |
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 |
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 |
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 |
K013047 |
12/06/2001 |
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM |
MOJCA VALIJAVEC |
MOJCA VALJAVEC |
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 |
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 |
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 |
K013036 |
12/07/2001 |
NOMOS MOTORIZED CRANE II |
NOMOS CORP. |
FRANCIS X DOBSCHA |
K013436 |
12/21/2001 |
NORMATEC PCD |
NORMATEC, INC. |
JONATHAN S KAHAN |
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 |
K013591 |
12/26/2001 |
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K013110 |
12/19/2001 |
ANISEIKONIA INSPECTOR |
OPTICAL DIAGNOSTICS, INC. |
JOYCE DE WIT |
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 |
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 |
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 |
K013340 |
12/20/2001 |
RT-PLUS KNEE ADDITIONAL COMPONENTS |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
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 |
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 |
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 |
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 |
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 |
K013379 |
12/12/2001 |
SAS STREPALERT |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
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 |
K013327 |
12/14/2001 |
CTS-415 |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
K010925 |
12/18/2001 |
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
SIEMENS ELEMA AB |
DIANE WURZBURGER |
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. |
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 |
K013658 |
12/05/2001 |
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
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 |
K013090 |
12/13/2001 |
SOPRO 67D OPERATING ROOM CAMERA |
SOPRO |
PIERRE MONTILLOT |
K012268 |
12/03/2001 |
TRIMAX |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
K013139 |
12/18/2001 |
STELLARTECH COAGULATION SYSTEM |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
K013630 |
12/05/2001 |
ISITE RADIOLOGY |
STENTOR, INC. |
GARY J ALLSEBROOK |
K013242 |
12/13/2001 |
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM |
STERIS Corporation |
ROBERT H MCCALL |
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 |
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 |
K013031 |
12/07/2001 |
MOST OPTIONS SYSTEM |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
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 |
K012415 |
12/18/2001 |
AURIS AEP |
SYNAPSYS, INC. |
JULIEN CHAUSSY |
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 |
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 |
K013248 |
12/19/2001 |
SYNTHES LCP DISTAL TIBIA PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
K013323 |
12/05/2001 |
TCI-31 LIFELONG OVULATION TESTER |
TCI NEW YORK |
Erika B Ammirati |
K013317 |
12/17/2001 |
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
TEKMEDIC (M) SDN BHD |
KOK-KEE HON |
K010443 |
12/11/2001 |
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K013849 |
12/03/2001 |
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS |
TETRAD CORP. |
CHARLES F HOTTINGER |
K012820 |
12/14/2001 |
AIA-PACK CTNI 2ND-GEN ASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
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 |
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 |
K013556 |
12/31/2001 |
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE |
TYCO HEALTHCARE |
DAVID A OLSON |
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 |
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 |
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 |
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 |
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 |
K013942 |
12/31/2001 |
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD H HUSSEIN |
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 |