| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K033022 |
11/21/2003 |
PROTEMP 3 GARANT |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K033041 |
11/21/2003 |
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K032879 |
11/13/2003 |
NAVIGATOR I |
ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. |
JOAN JOHNSON |
| K033401 |
11/20/2003 |
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER |
ADVANCED CIRCULATORY SYSTEMS, INC. |
Gary Syring |
| K033597 |
11/25/2003 |
ATR 5000, LC 5000, IMPLANT SYSTEM |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
DANIELE POLI |
| K032481 |
11/04/2003 |
THERATEARS CONTACT LENS COMFORT DROPS |
ADVANCED VISION RESEARCH, INC. |
BEVERLEY D VENUTI |
| K032849 |
11/21/2003 |
AERONEB GO NEBULIZER, MODEL AG-AG2000 |
AEROGEN, INC. |
Nancy E Isaac |
| K033013 |
11/25/2003 |
MDIFICATION TO MEDIPRIME |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K032744 |
11/13/2003 |
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC. |
HOWARD L SCHRAYER |
| K033345 |
11/19/2003 |
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS |
ANALOGIC CORP. |
MARVIN ROSENBAUM |
| K033443 |
11/19/2003 |
SPEEDLYSER INFUSION CATHETER KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K031385 |
11/10/2003 |
ANZAI AZ-733 RESPIRATORY GATING SYSTEM |
ANZAI MEDICAL CO, LTD. |
T. WHIT ATHEY |
| K033333 |
11/14/2003 |
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
| K031553 |
11/18/2003 |
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES |
ARCADIA MEDICAL CORPORATION |
ARTHUR WARD |
| K031153 |
11/25/2003 |
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 |
ARROW INTL., INC. |
WILLIAM G MCLAIN |
| K031666 |
11/18/2003 |
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS |
ARTHREX, INC. |
ANN WATERHOUSE |
| K033584 |
11/28/2003 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K032160 |
11/17/2003 |
ARTELON SURGICAL SUTURE |
ARTIMPLANT AB |
RUSS PAGANO |
| K033015 |
11/25/2003 |
AXIOM BIOLASER LLLT SERIES-3 |
AXIOM USA. INC |
JIM GIBSON |
| K031646 |
11/14/2003 |
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K031676 |
11/20/2003 |
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K033007 |
11/14/2003 |
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K033350 |
11/18/2003 |
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER |
BECTON DICKINSON & CO. |
M. WENDY BALLESTEROS |
| K031375 |
11/20/2003 |
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 |
BESMED HEALTH BUSINESS CORP. |
DR. JEN KE MIN |
| K031374 |
11/28/2003 |
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 |
BESMED HEALTH BUSINESS CORP. |
DR. JEN KE MIN |
| K032874 |
11/24/2003 |
HBA SPERM-HYALURONAN BINDING ASSAY |
BIOCOAT, INC. |
JAMES B JOHNSTON |
| K032425 |
11/05/2003 |
INVISIJECT RESUSABLE AUTO-INJECTOR |
BIOGEN |
Michael Poirier |
| K032788 |
11/04/2003 |
VITEK 2 GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032861 |
11/12/2003 |
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032286 |
11/20/2003 |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
| K032895 |
11/20/2003 |
BI-ANGULAR SHOULDER SYSTEM |
BIOMET, INC. |
PATRICIA S BERES |
| K033233 |
11/05/2003 |
LACTOSORB TIBIAL L-15 SCREW AND WASHER |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K032992 |
11/21/2003 |
UNIMARK HOME PREGNANCY TEST DEVICE |
BIOTECH ATLANTIC, INC. |
FRANCIS L DENG |
| K033320 |
11/19/2003 |
SCOUT PRO |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K032597 |
11/04/2003 |
BISCEM GI |
BISCO, INC. |
KATHY JOUNG |
| K032713 |
11/24/2003 |
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K033441 |
11/21/2003 |
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER |
BOSTON SCIENTIFIC CORP. |
HEIDI M ERICKSON |
| K032940 |
11/20/2003 |
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K032938 |
11/20/2003 |
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K033438 |
11/20/2003 |
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD KELLER |
| K032521 |
11/14/2003 |
BARD DUAL LUMEN URETERAL CATHETER |
C.R. BARD, INC. |
FRANCES HARRISON |
| K030792 |
11/14/2003 |
BARD ENDOTRACHEAL TUBE, CUFFED |
C.R. BARD, INC. |
FRANCES E HARRISON |
| K033245 |
11/06/2003 |
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U |
C.R. BARD, INC. |
MICHAEL A PATZ |
| K033294 |
11/26/2003 |
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER |
C.R. BARD, INC. |
GLENN NORTON |
| K023452 |
11/20/2003 |
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E |
CANOPUS MEDICAL SUPPLY CO., LTD. |
RUBY LIN |
| K032444 |
11/13/2003 |
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY |
Cardinal Health |
ERICA SETHI |
| K021594 |
11/13/2003 |
COPC BAND |
CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC |
JOSEPH TERPENNING |
| K023874 |
11/20/2003 |
SYSTEM 100 ULTRAFILTRATION CATHETER |
CHF SOLUTIONS, INC. |
AMY PETERSON |
| K033593 |
11/20/2003 |
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
| K031042 |
11/03/2003 |
ATAC HEMOGLOBIN A1C REAGENT KIT |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K032662 |
11/03/2003 |
GUTTAFLOW |
COLTENE/WHALEDENT GMBH & CO. KG |
HENRY J VOGELSTEIN |
| K031007 |
11/14/2003 |
KWIKEZE MALE CONDOM APPLICATOR |
CONDAX LLC. |
ELI J CARTER |
| K033093 |
11/05/2003 |
ECHOCONNEX COMMUNICATOR |
CONNEXMD |
CURTIS LEBLEU |
| K032869 |
11/19/2003 |
COOK CODA BALLOON CATHETER |
COOK, INC. |
Theodore Heise |
| K031494 |
11/12/2003 |
DOC'S BEST WHITE COPPER CEMENT |
COOLEY & COOLEY, LTD. |
M. JOYCE HEINRICH |
| K032873 |
11/07/2003 |
PROCLEAR COMPATIBLES MULTIFOCAL |
COOPER VISION, INC. |
LISA HAHN |
| K033431 |
11/20/2003 |
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K032383 |
11/28/2003 |
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM |
CURELIGHT LTD |
JONATHAN S KAHAN |
| K032539 |
11/17/2003 |
CYNOSURE PHOTOGENICA SV LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K032697 |
11/07/2003 |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K033482 |
11/26/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K033281 |
11/26/2003 |
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE |
DATEX-OHMEDA |
JOEL KENT |
| K033144 |
11/13/2003 |
DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES |
DEFIBTECH, LLC |
JOHN L ROGERS |
| K031793 |
11/13/2003 |
DENTATUS OSCIOMAT |
DENTATUS USA, LTD. |
RICHARD C LANZILLOTTO |
| K030644 |
11/21/2003 |
CONTEC DUO, CONTEC LC, CONTEC LCR |
DENTAURUM |
JAN W A DOORSCHODT |
| K021478 |
11/18/2003 |
DELTA SHOULDER |
DEPUY, INC. |
JANET G JOHNSON |
| K033329 |
11/14/2003 |
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS |
DEPUY, INC. |
RHONDA MYER |
| K033057 |
11/20/2003 |
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE |
DEROYAL |
SHARON COOK |
| K033385 |
11/07/2003 |
DGH 55 HANDHELD PACHYMETER (PACHMATE) |
DGH TECHNOLOGY, INC. |
M. LUTHER DETWEILER |
| K033061 |
11/07/2003 |
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
| K032537 |
11/25/2003 |
DRAEGER MICRO2+ AND MASIMO MINISAT |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K031132 |
11/26/2003 |
CONSULTIVA CASE INPUT STATION, MODEL CIS-1 |
EASTMAN KODAK COMPANY |
WIDO MENHARDT |
| K031946 |
11/03/2003 |
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE |
EDWARDS LIFESCIENCES, LLC. |
JEAN CHANG |
| K032935 |
11/20/2003 |
EPI-SCAN, MODEL P 100 |
EDX EPI-SCAN, INC. |
GREG HOLLAND |
| K033204 |
11/12/2003 |
ESG 4-WHEEL SCOOTER, ESG-03 |
EMG TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| K023120 |
11/12/2003 |
OXYCON MOBILE |
ERICH JAEGER GMBH |
EARL DRAPER |
| K033134 |
11/17/2003 |
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
| K033314 |
11/21/2003 |
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
| K032964 |
11/13/2003 |
EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS |
EXACTECH, INC. |
GARY J MILLER |
| K033452 |
11/28/2003 |
CWAS 1000 |
FASSTECH |
LEE BRODY |
| K033368 |
11/26/2003 |
FOSSA URETERAL OPEN LUMEN STENT |
FOSSA MEDICAL, INC. |
GLORIA KOLB |
| K033370 |
11/28/2003 |
POWERED WHEELCHAIR, MODEL FR168W |
FREERIDER, CORP. |
ROBERT S MCQUATE |
| K033561 |
11/26/2003 |
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FRANK GIANELLI |
| K033365 |
11/06/2003 |
APEXPRO FH TELEMETRY SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K033304 |
11/12/2003 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K033492 |
11/24/2003 |
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA LEE MICHELS |
| K033502 |
11/20/2003 |
LIGHTSPEED 6.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
JOHN W JAECKLE |
| K033504 |
11/25/2003 |
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER, PH.D. |
| K033393 |
11/10/2003 |
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM |
GUIDANT CORP. |
KELLY PIKE |
| K033554 |
11/24/2003 |
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS |
GYRUS ENT L.L.C. |
GREGORY SREDIN |
| K024286 |
11/17/2003 |
GYRUS OPEN FORCEPS |
GYRUS MEDICAL, INC. |
MARK JENSEN |
| K033112 |
11/05/2003 |
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS |
HAND BIOMECHANICS LAB, INC. |
TIMOTHY R STALLINGS |
| K032802 |
11/19/2003 |
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III |
HK SURGICAL, INC. |
SALLY M BOWDON |
| K033224 |
11/05/2003 |
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K033473 |
11/18/2003 |
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT |
HORIZON MEDICAL PRODUCTS, INC. |
SCOTT MOELLER |
| K033145 |
11/05/2003 |
HOFFMANN II PELVIC CLAMP |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K030978 |
11/20/2003 |
SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
DENISE DUCHENE |
| K033188 |
11/19/2003 |
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 |
IDEV TECHNOLOGIES, INC. |
LYNNE A DAVIES |
| K033292 |
11/26/2003 |
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 |
IGC-MEDICAL ADVANCES, INC. |
ANTHONY DIETZLER |
| K030263 |
11/24/2003 |
IMMUNICON CELLTRACKS ANALYZER |
IMMUNICON CORP. |
PETER SCOTT |
| K033430 |
11/07/2003 |
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 |
IMPLANT INNOVATIONS, INC. |
TAMARA NELSON |
| K033384 |
11/19/2003 |
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ |
IMPLEX CORP. |
MARCI HALEVI |
| K030802 |
11/25/2003 |
CAPHOSOL |
INPHARMA A.S. |
BRUCE MANNING |
| K033187 |
11/19/2003 |
INTERLAB IMMUNOFIXATION TEST(S) |
INTERLAB S.R.L. |
Gary Lehnus |
| K032784 |
11/18/2003 |
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K031842 |
11/21/2003 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K033199 |
11/12/2003 |
COMPACT DIGITAL CARDIAC CAMERA (CDCC) |
IS2 MEDICAL SYSTEMS, INC. |
VICTOR WOODBURN |
| K032519 |
11/12/2003 |
ENDO PAT 2000 |
ITAMAR MEDICAL |
DORIT WINITZ |
| K032470 |
11/05/2003 |
MULTILINK |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K031722 |
11/25/2003 |
JSA REPROCESSED COMPRESSION SLEEVE DEVICES |
JACK SPEER AND ASSOC., INC. |
JACK SPEER |
| K032087 |
11/26/2003 |
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 |
KEELER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K033021 |
11/12/2003 |
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K032670 |
11/14/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR |
KINGSWELL INTERNATIONAL INC. |
D.C. CHANG |
| K030359 |
11/06/2003 |
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K032455 |
11/07/2003 |
PANAVIA F 2.0 |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
| K031419 |
11/24/2003 |
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K032871 |
11/10/2003 |
PLANET MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K032867 |
11/10/2003 |
STAR (LUNAR SERIES) MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K024206 |
11/17/2003 |
AURA ISURGICAL LASER SYSTEM & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
| K032774 |
11/26/2003 |
RENOVA INTERNAL HEX IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
Diane Brinza |
| K032764 |
11/03/2003 |
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K032607 |
11/10/2003 |
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 |
LINVATEC CORP. |
LAURA KREJCI |
| K033565 |
11/21/2003 |
LMT NOMAG IC 1,5 |
LMT LAMMERS MEDICAL TECHNOLOGY GMBH |
THOMAS M BOHNEN |
| K031170 |
11/13/2003 |
POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS |
LONG FIRST (XIAMEN) CO.,LTD. |
STONE CHEN |
| K031997 |
11/25/2003 |
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM |
MALLINCKRODT DAR S.R.L. |
GIUSEPPE TOMASINI |
| K031463 |
11/18/2003 |
MARINA MEDICAL SILICONE PESSARY |
MARINA MEDICAL INSTRUMENTS, INC. |
JAY MANSOUR |
| K031876 |
11/21/2003 |
ELECTRO FLO PERCUSSOR, MODEL 5000 |
MED SYSTEMS |
DANIEL KAMM |
| K011261 |
11/17/2003 |
STONE EXTRACTOR BALLOON CATHETER |
MEDI-GLOBE CORP. |
SCOTT KARLER |
| K032094 |
11/14/2003 |
PASSMED SPINAL SYSTEM |
MEDICREA |
J.D. WEBB |
| K033102 |
11/05/2003 |
MEDIC COLON MODEL, RELEASE 1 |
MEDICSIGHT |
CAROL MACDONALD |
| K032823 |
11/10/2003 |
MEDICHEART, MODEL RELEASE 1 |
MEDICSIGHT |
CAROL MACDONALD |
| K032308 |
11/10/2003 |
BLOOD PRESSURE MONITOR, MODEL M100 |
MEDITEK TECHNOLOGY, INC. |
TONY C.S. CHANG |
| K033247 |
11/05/2003 |
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
MEDRAD, INC. |
TROY A JACK |
| K033334 |
11/10/2003 |
PROFILE -ER |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K033468 |
11/14/2003 |
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE |
MEDTRONIC PERFUSION SYSTEMS |
MICHELE PYFFEROEN |
| K033416 |
11/05/2003 |
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K033275 |
11/06/2003 |
LIFEPAK 12, 20, 500, CR PLUS |
MEDTRONIC PHYSIO-CONTROL CORP. |
MICHELLE ACKERMANN |
| K033271 |
11/06/2003 |
DYNALOK CLASSIC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K032811 |
11/24/2003 |
CEDIA VANCOMYCIN ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
| K031024 |
11/14/2003 |
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K032995 |
11/20/2003 |
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) |
MICRON CORP. |
TAKASHI TERUI |
| K033390 |
11/04/2003 |
COLIBRI DISPOSABLE VITRECTOMY CUTTER |
MICROWORLD MEDICAL INSTRUMENTS, INC. |
SEMYON GAMBARIN |
| K032872 |
11/28/2003 |
MICRUS MICROCOIL SYSTEM |
MICRUS CORP. |
MARGARET WEBBER |
| K031799 |
11/12/2003 |
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 |
MIELE, INC. |
STEVE POLINSKI |
| K031541 |
11/18/2003 |
PARADIGMPAL, MODEL MMT-7330 |
MINIMED, INC. |
GERDA P RESCH |
| K033277 |
11/04/2003 |
HYDRAGEL CSF ISOFOCUSING KITS |
MORAX |
BOREK JANIK |
| K032934 |
11/13/2003 |
MPS ACACIA SAFEGUARD HUBER DEVICE |
MPS ACACIA |
FERGIE F FERGUSON |
| K033567 |
11/25/2003 |
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K031820 |
11/12/2003 |
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 |
MULTINATIONAL |
GRACE HOLLAND |
| K030787 |
11/14/2003 |
SHILEY FLEXTRA TRACHEOSTOMY TUBE |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K033321 |
11/05/2003 |
SELECTIVA SB GUIDEWIRE |
NEO METRICS, INC. |
MARK PEDERSON |
| K033427 |
11/10/2003 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
| K032777 |
11/14/2003 |
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
RICHARD D BLISS |
| K031073 |
11/05/2003 |
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
| K033486 |
11/19/2003 |
GE PRECISION MPI |
NRT-NORDISK RONTGEN TEKNIK A/S |
JAN MALLING |
| K032476 |
11/13/2003 |
NUVASIVE MESH |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K033386 |
11/26/2003 |
NXSTAGE PUREFLOW SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K022304 |
11/14/2003 |
ACCUMAP AUTOMATIC PERIMETER |
OBJECTIVISION PTY LTD. |
FRED HENRY |
| K031380 |
11/14/2003 |
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K032665 |
11/21/2003 |
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K033300 |
11/05/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
CHARLOTTE BAKER |
| K030958 |
11/20/2003 |
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K032130 |
11/05/2003 |
VITOSS-FILLED CARTRIDGE |
ORTHOVITA, INC. |
ANDREINA ANGIE IDE |
| K031708 |
11/03/2003 |
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDERMAN |
| K033119 |
11/18/2003 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA E DILLON |
| K032753 |
11/18/2003 |
GLUCOSE TOLERANCE BEVERAGE |
PERK SCIENTIFIC, INC. |
MARK BARTOSH |
| K032613 |
11/20/2003 |
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE |
PETER M. ROTHENBERG, M.D. |
PETER M ROTHENBERG |
| K033444 |
11/21/2003 |
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER |
PHILIPS MEDICAL SYSTEMS |
TAPAN D SHAH |
| K032636 |
11/14/2003 |
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) |
PLAYTEX PRODUCTS, INC. |
KAREN A COSTA |
| K032716 |
11/28/2003 |
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) |
PORTEX LTD. |
STEVE OGILVIE |
| K032804 |
11/03/2003 |
CRYOCHECK WEAK LUPUS POSITIVE CONTROL |
PRECISION BIOLOGIC |
STEPHEN DUFF |
| K032331 |
11/20/2003 |
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) |
PRO-MED INSTRUMENTS GMBH |
JIM BAZZINOTTI |
| K032260 |
11/20/2003 |
ARAMIS II DERMATOLOGICAL LASER |
QUANTEL MEDICAL |
ROGER W BARNES |
| K032379 |
11/20/2003 |
QUASAR, MODEL MD21 |
QUANTUM SKINCARE, INC. |
J. HARVEY KNAUSS |
| K031795 |
11/10/2003 |
RELIANT LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K031965 |
11/14/2003 |
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 |
REMEL INC |
RICHARD TYSON |
| K031942 |
11/18/2003 |
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 |
REMEL INC |
RICHARD TYSON |
| K031834 |
11/10/2003 |
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY |
REMEL INC |
EARLEEN C PARKS |
| K031559 |
11/12/2003 |
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES |
RENU MEDICAL, INC. |
L. BRUCE PIERSON |
| K022750 |
11/20/2003 |
PLV CONTINUUM VENTILATOR, MODEL P1000 |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
| K032809 |
11/13/2003 |
HOSPITAL SPACER |
RESPIRONICS HEALTHSCAN, INC. |
SUSAN D GOLDSTEIN-FALK |
| K032852 |
11/12/2003 |
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 |
REVIVANT CORP. |
BOB H KATZ |
| K032646 |
11/12/2003 |
ELECSYS PROBNP IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K033501 |
11/20/2003 |
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K033548 |
11/24/2003 |
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K031236 |
11/14/2003 |
AUTO-BAND LIGATOR |
SCANDIMED. A.S. |
KRISTIAN K JENSEN |
| K032460 |
11/13/2003 |
PROFILE BBL SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K032739 |
11/20/2003 |
UCR SPINAL SYSTEM |
SEASPINE |
DIANA SMITH |
| K032708 |
11/20/2003 |
PLASTALGIN AND PLASTALGIN ORTHO |
SEPTODONT |
WAYNE H MATELSKI, ESQ. |
| K023537 |
11/20/2003 |
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K030583 |
11/10/2003 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K032908 |
11/20/2003 |
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
CHEN YUHONG |
| K032907 |
11/20/2003 |
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
CHEN YUHONG |
| K033374 |
11/06/2003 |
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
SIEMENS AG, MEDICAL SOLUTIONS |
RUDIGER KORNER |
| K033335 |
11/25/2003 |
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DEBBIE PEACOCK |
| K031340 |
11/25/2003 |
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K032536 |
11/10/2003 |
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE K HARTMAN |
| K032475 |
11/10/2003 |
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
| K033238 |
11/14/2003 |
MOBILETTE XP AND MOBILETT XPHYBRID |
SIEMENS MEDICAL SYSTEMS, INC. |
NEALIE HARTMAN |
| K031546 |
11/13/2003 |
RAINBOW GT-4A PAIN RELIEF MACHINE |
SINO-US INFORMATION, INC |
YITANG SHENG |
| K032543 |
11/14/2003 |
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K033509 |
11/28/2003 |
MODIFICATION TO VERSABOND BONE CEMENT |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K033442 |
11/26/2003 |
REFLECTION CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
KANU VADODARIA |
| K032967 |
11/14/2003 |
PASCAL DYNAMIC CONTOUR TONOMETER |
SMT SWISS MICROTECHNOLOGY AG |
Kevin Walls |
| K033367 |
11/05/2003 |
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K033325 |
11/06/2003 |
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K033425 |
11/06/2003 |
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K032787 |
11/20/2003 |
NEUROLASE, MODELS 150V, 150C, 1064 |
SPECTRUM LASER & TECHNOLOGIES |
THOMAS R RADEBAUGH |
| K014200 |
11/26/2003 |
OPTIMESH |
SPINEOLOGY, INC. |
PAMELA R SNYDER |
| K031798 |
11/12/2003 |
GOOD MORNING TEST |
STANDARD DIAGNOSTICS, INC. |
RICHARD C LANZILLOTTO |
| K032824 |
11/13/2003 |
STELKAST UNICONDYLAR KNEE SYSTEM |
STELKAST COMPANY |
DONALD STEVENS |
| K033252 |
11/13/2003 |
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K032473 |
11/07/2003 |
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| K032880 |
11/10/2003 |
SUMMIT STAIRWAY LIFT |
SUMMIT LIFTS, INC. |
KENT PERRY |
| K033358 |
11/14/2003 |
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 |
SURGITECH, INC. |
CHRISTOPHER CROWELL |
| K032921 |
11/13/2003 |
PREMISE |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K032598 |
11/24/2003 |
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE |
SYNERGETICS, INC. |
DAN REGAN |
| K031175 |
11/14/2003 |
CLICK'X MONOAXIAL SCREWS AND HOOKS |
SYNTHES (USA) |
JOHN WALSH |
| K033071 |
11/05/2003 |
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K033411 |
11/26/2003 |
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS |
SYNTHES (USA) |
BONNIE SMITH |
| K033158 |
11/05/2003 |
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES |
SYNTHES (USA) |
ANGLELA J SILVESTRI |
| K033097 |
11/12/2003 |
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02 |
TAIWAN KING STRONG CO., LTD. |
JEN KE-MIN |
| K033274 |
11/04/2003 |
GIARDIA II |
TECHLAB, INC. |
DAVID M LYERLY |
| K032520 |
11/12/2003 |
ORTRAUTEK TRAUMA SYSTEM |
TEKKA |
FAYYAZ MEMON |
| K032685 |
11/26/2003 |
CEMSTOP CEMENT RESTRICTOR |
TEKNIMED SA |
J.D. WEBB |
| K031826 |
11/28/2003 |
TRIHA + |
TEKNIMED SA |
J. D WEBB |
| K033115 |
11/17/2003 |
ORTHODEK |
TELEFLEX MEDICAL |
STEPHEN PAGE |
| K032230 |
11/26/2003 |
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE |
THINKLABS INC. |
RICHARD LANZILLOTTO |
| K033346 |
11/03/2003 |
SPI EASY DENTAL IMPLANT PROTECTIVE CAP |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K033035 |
11/20/2003 |
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS |
TLC MARKETING, INC. |
ROBERT MAZZAFERRO |
| K033347 |
11/12/2003 |
MODIFICATION TO: HI-ART SYSTEM |
TOMOTHERAPY INCORPORATED |
KENNETH D BUROKER |
| K033418 |
11/10/2003 |
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K033083 |
11/26/2003 |
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033070 |
11/26/2003 |
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033079 |
11/26/2003 |
CHLAMYDIA IGG ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033051 |
11/26/2003 |
LEGIONELLA PNEUMOPHILA IGG/IGM |
TRINITY BIOTECH USA |
BONNIE DEJOY |
| K033064 |
11/26/2003 |
MYCOPLASMA IGG |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033067 |
11/26/2003 |
PYLORI IGG |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033059 |
11/26/2003 |
HERPES GROUP IGG |
TRINITY BIOTECH, INC. |
BONNIE DEJOY |
| K033241 |
11/10/2003 |
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 |
TUNG KENG ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K033239 |
11/12/2003 |
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 |
TUNG KENG ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K033219 |
11/12/2003 |
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 |
TUNG KENG ENTERPRISE CO., LTD. |
JEN KE-MIN |
| K033373 |
11/13/2003 |
MONOJECT INSULIN SYRINGE |
TYCO HEALTHCARE |
DAVID OLSON |
| K032627 |
11/12/2003 |
ULTRADENT CITRIC ACID 10% SOLUTION |
ULTRADENT PRODUCTS, INC. |
PETER ALLRED |
| K032586 |
11/17/2003 |
CAPROSYN ABSORBABLE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ROBERT ZOTT |
| K031493 |
11/20/2003 |
GROWTH GUIDANCE PLATE |
UNIVERSITY OF UTAH/SCHOOL OF MEDICINE |
PETER M STEVENS |
| K032987 |
11/17/2003 |
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 |
UNOTECH DIAGNOSTICS, INC. |
KEN WU |
| K033353 |
11/14/2003 |
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K033499 |
11/28/2003 |
MALIS IRRIGATION MODULE 1000 |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K031524 |
11/26/2003 |
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K033237 |
11/20/2003 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
DEBORAH L JENSEN |
| K031515 |
11/14/2003 |
SPIROPRO SPO2 |
VIASYS HEALTHCARE GMBH |
EARL DRAPER |
| K033361 |
11/05/2003 |
VIATRONIX V3D VASCULAR, REVISION 1.0 |
VIATRONIX, INC. |
FRANK DACHILLE |
| K030419 |
11/06/2003 |
VITERION 100 TELEHEALTH MONITOR |
VITERION TELEHEALTHCARE LLC |
THUY NGUYEN |
| K033117 |
11/25/2003 |
GRANDIO FLOW |
VOCO GMBH |
GERALD W SHIPPS |
| K032865 |
11/28/2003 |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W. L. GORE & ASSOCIATES, INC. |
MIKE JOHNSON |
| K033446 |
11/13/2003 |
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K033434 |
11/12/2003 |
BESTALOY |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K033435 |
11/12/2003 |
E-SARANG 86, DM78, DM55 |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K030319 |
11/26/2003 |
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| K032647 |
11/07/2003 |
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K033032 |
11/10/2003 |
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR |
WU'S TECH CO., LTD. |
Ke-Min Jen |
| K032617 |
11/12/2003 |
WU'S 4-WHEELED SCOOTER, WT-L4JR |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K033066 |
11/12/2003 |
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM |
XITEC HOLDINGS LLC. |
DANIEL J DILLON |
| K032512 |
11/12/2003 |
Y.E.S POWERED WHEELCHAIR. T180 |
YEOU EIR SHUEN MACHINERY CO., LTD. |
JEN KE-MIN |
| K032669 |
11/12/2003 |
Y.E.S. POWERED WHEELCHAIR, MODEL T200 |
YEOU EIR SHUEN MACHINERY CO., LTD. |
Ke-Min Jen |
| K032781 |
11/13/2003 |
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHEN YUHONG |
| K032783 |
11/13/2003 |
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHEN YUHONG |
| K033034 |
11/05/2003 |
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS |
ZIMMER, INC. |
KAREN CAIN |
| K032691 |
11/13/2003 |
ZOLL AUTOCLAVABLE INTERNAL HANDLES |
ZOLL MEDICAL CORP. |
PAUL DIAS |
| K032439 |
11/05/2003 |
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) |
ZOLL MEDICAL CORP. |
SCOTT AUGUST |
