| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K000027 |
04/03/2000 |
INSUFFLATION NEEDLE, MODEL R65-933 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K993116 |
04/12/2000 |
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER |
A & D ENGINEERING, INC. |
JERRY WANG |
| K000961 |
04/19/2000 |
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
| K000366 |
04/14/2000 |
FIXATION STYLETS, MODELS 335-287 AND 335-288 |
ACCUFIX RESEARCH INSTITUTE |
MICHAEL J ANDREWS |
| K000478 |
04/19/2000 |
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 |
ACCURAY, INC. |
LUANNE NG |
| K991818 |
04/17/2000 |
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K993923 |
04/07/2000 |
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
JANICE E BROWN |
| K000908 |
04/05/2000 |
SKYLIGHT IMAGING SYSTEM |
ADAC LABORATORIES |
JANICE E BROWN |
| K991380 |
04/19/2000 |
OIL FOR TISSUE CULTURE |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
GREG HOLLAND |
| K000486 |
04/14/2000 |
ABC CERVICAL PLATING SYSTEM |
AESCULAP, INC. |
LIA S JONES |
| K000822 |
04/06/2000 |
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR |
AGILENT TECHNOLOGIES, GMBH |
EGON PFEIL |
| K000854 |
04/10/2000 |
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
| K000148 |
04/11/2000 |
RGP MULTI-PURPOSE SOLUTION ID 100136 |
ALCON LABORATORIES |
RALPH H LARSEN |
| K000385 |
04/28/2000 |
OPTI-FREE EXPRESS LENS DROPS |
ALCON UNIVERSAL, LTD. |
RALPH H LARSEN |
| K993871 |
04/21/2000 |
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K001189 |
04/21/2000 |
MODIFICATION TO CONVERTORS SURGICAL GOWNS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K993513 |
04/26/2000 |
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM |
ALPHATEC MFG., INC. |
JASON BLAIN |
| K992451 |
04/03/2000 |
RAPIDONE- BARBITURATE TEST |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K992720 |
04/03/2000 |
RAPIDONE- BENZODIAZEPINE TEST |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K991519 |
04/14/2000 |
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
AMERIWATER |
SANDRA E MONSMAN |
| K000539 |
04/27/2000 |
NYLON NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
RICHARD KUO |
| K000542 |
04/28/2000 |
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
RICHARD KUO |
| K000540 |
04/27/2000 |
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
RICHARD KUO |
| K000537 |
04/27/2000 |
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
RICHARD KUO |
| K000541 |
04/28/2000 |
SILK NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
RICHARD KUO |
| K000508 |
04/18/2000 |
THERMOFLEX SYSTEM |
ARGOMED, INC. |
RICHARD B KLEIN |
| K000748 |
04/06/2000 |
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
ARMKEL, LLC. |
STEPHEN C KOLAKOWSKY |
| K000740 |
04/12/2000 |
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S |
ASAHI IRYOKI CO. LTD |
MIKE PAWLUK |
| K000964 |
04/25/2000 |
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K000117 |
04/13/2000 |
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE |
AVID MEDICAL, INC. |
SEAN F SHEMANSKI |
| K000206 |
04/13/2000 |
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 |
AXELGAARD MFG. CO., LTD. |
DAN JEFFERY |
| K000247 |
04/20/2000 |
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER |
BAUSCH & LOMB, INC. |
YVONNE MIDDLEFELL |
| K993867 |
04/10/2000 |
BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K994221 |
04/13/2000 |
BAYER PSA ASSAY |
BAYER CORP. |
William J Pignato |
| K000829 |
04/13/2000 |
GATIFLOXACIN, 5 UG, BBL SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
BRADFORD SPRING |
| K000762 |
04/25/2000 |
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
BRADFORD SPRING |
| K000494 |
04/14/2000 |
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K000410 |
04/10/2000 |
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K000235 |
04/05/2000 |
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K000962 |
04/20/2000 |
PICO SMOKERLYZER, MODEL EC-50 |
BEDFONT SCIENTIFIC LTD. |
MARTIN FOXLEY |
| K000650 |
04/20/2000 |
BETEL POWDER FREE LATEX EXAM GLOVES |
BETELCARE SDN BHD |
K.B. SIAH |
| K000652 |
04/10/2000 |
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
BETELCARE SDN BHD |
KENG BENG SIAH |
| K992781 |
04/05/2000 |
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 |
BIO-RAD |
ELIZABETH PLATT |
| K000875 |
04/20/2000 |
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 |
BIO-RAD |
ELIZABETH PLATT |
| K000874 |
04/18/2000 |
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 |
BIO-RAD |
ELIZABETH PLATT |
| K000290 |
04/14/2000 |
LAZERSMILE, LAZERWHITE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| K000299 |
04/28/2000 |
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D |
BIOMEDEX, INC. |
JAMES L THOMPSON |
| K000262 |
04/03/2000 |
BOHN FEMORAL COMPONENT |
BIOMET MANUFACTURING, INC. |
TINA LAKIN |
| K001010 |
04/27/2000 |
ASCENT KNEE REVISION FEMORAL STEM |
BIOMET, INC. |
TINA LAKIN |
| K990830 |
04/11/2000 |
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K000764 |
04/06/2000 |
PEDIATRIC FIXATION RODS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K991549 |
04/26/2000 |
EMBOSPHERE MICROSPHERES |
BIOSPHERE MEDICAL |
SHEILA HEMEON-HEYER |
| K000763 |
04/06/2000 |
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 |
BIOTRONIK, GMBH & CO. |
Jon Brumbaugh |
| K994240 |
04/13/2000 |
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K000426 |
04/12/2000 |
VIP- VARIABLE INTENSITY POLYMERIZER |
BISCO, INC. |
KATHRYN B PATTERSON |
| K000570 |
04/13/2000 |
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
| K000177 |
04/07/2000 |
RENEGADE HI-FLO MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
| K993305 |
04/10/2000 |
TRANSLUMINAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
| K000956 |
04/21/2000 |
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
BOSTON SCIENTIFIC SCIMED, INC. |
MELANIE RASKA |
| K000125 |
04/12/2000 |
JET PORT PLUS CATHETER SYSTEM |
CLINICAL PLASTIC PRODUCTS SA |
SALVADORE F PALOMARES |
| K000255 |
04/25/2000 |
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K993545 |
04/14/2000 |
TENAX WHITE POST |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K000147 |
04/13/2000 |
CTC DVT-1 CALF GARMENT, MODEL DVT-1 |
COMPRESSION THERAPY CONCEPTS, INC. |
J. JAMES BRITTON |
| K000137 |
04/17/2000 |
ENHANCED COMPENSATING FILTER |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
| K000810 |
04/13/2000 |
QUALITROL LIPID CONTROL, LEVELS 1 AND 2 |
CONSOLIDATED TECHNOLOGIES OF WISCONSIN |
RUSTY SEWELL |
| K000245 |
04/18/2000 |
CSM STRETTA SYSTEM |
CONWAY STUART MEDICAL, INC. |
JONATHAN S KAHAN |
| K000753 |
04/06/2000 |
CORDIS 13F CATHETER SHEATH INTRODUCER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K001136 |
04/28/2000 |
CORDIS INTRODUCER GUIDE |
CORDIS CORP. |
ARIEL MACTAVISH |
| K001033 |
04/14/2000 |
AGILITY STEERABLE GUIDEWIRE |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
| K000920 |
04/26/2000 |
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K000198 |
04/11/2000 |
CORTEK ARTHROSCOPE |
CORTEK ENDOSCOPY, INC. |
CORNEL M TOPALA |
| K000199 |
04/13/2000 |
CORTEK MINI LAPAROSCOPE |
CORTEK ENDOSCOPY, INC. |
CORNEL M TOPALA |
| K993356 |
04/20/2000 |
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES |
COULTER CORP. |
STAN SUGRUE |
| K001020 |
04/28/2000 |
8100 VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K993489 |
04/14/2000 |
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS |
CRYSTAL REFLECTIONS, INT., INC. |
JACK CARTER |
| K000649 |
04/25/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K000460 |
04/14/2000 |
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000459 |
04/03/2000 |
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000458 |
04/17/2000 |
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000461 |
04/06/2000 |
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000467 |
04/14/2000 |
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000466 |
04/05/2000 |
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000464 |
04/14/2000 |
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000462 |
04/06/2000 |
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A |
DADE BEHRING, INC. |
JUDY MCINNIS-BERGER |
| K000168 |
04/13/2000 |
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) |
DATEX-OHMEDA |
JOEL KENT |
| K993410 |
04/25/2000 |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
| K993608 |
04/13/2000 |
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K000275 |
04/12/2000 |
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
| K000112 |
04/13/2000 |
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 |
DENTSPLY INTL. |
WILLIAM T COUSINS |
| K001105 |
04/24/2000 |
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS |
DEPUY ACROMED |
LISA GILMAN |
| K000432 |
04/24/2000 |
RESPONSE 2000 CEMENTED HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K000392 |
04/24/2000 |
RESPONSE 2000 HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K001118 |
04/25/2000 |
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K001021 |
04/25/2000 |
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 |
DIDECO S.P.A. |
BARRY SALL |
| K000878 |
04/11/2000 |
HONIGUM |
DMG USA, INC. |
PAMELA PAPINEAU |
| K000951 |
04/05/2000 |
LUXAFORM |
DMG USA, INC. |
PAMELA PAPINEAU |
| K992553 |
04/12/2000 |
IQ CHAMBERS |
DORMER LABORATORIES, INC. |
DANIEL MANELLI |
| K000043 |
04/17/2000 |
DRG AURICA ELISA TESTOSTERONE KIT |
DRG INTL., INC. |
NIKOLAS BUTKOV |
| K000400 |
04/18/2000 |
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJEES |
| K000522 |
04/18/2000 |
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K000449 |
04/07/2000 |
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K000350 |
04/11/2000 |
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K000452 |
04/24/2000 |
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K000273 |
04/07/2000 |
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K000402 |
04/18/2000 |
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST |
DRUG DETECTION DEVICES, LTD. |
PATRICK BEENTJES |
| K992732 |
04/20/2000 |
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SAM LAKHANI |
| K001037 |
04/14/2000 |
MODIFICATION TO EBI SPINELINK SYSTEM |
EBI, L.P. |
JONAS WILF |
| K000029 |
04/04/2000 |
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K993448 |
04/10/2000 |
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K000474 |
04/19/2000 |
VIEW NT |
ELECTROMED INTL., LTD. |
PASCAL M KAUFMANN |
| K993630 |
04/26/2000 |
BIOLOK SCREW |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K000314 |
04/12/2000 |
INCENTIVE SPIROMETER |
ENGINEERED MEDICAL SYSTEMS |
BONNIE HOLLY |
| K000646 |
04/13/2000 |
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE |
ENTERIC MEDICAL TECHNOLOGIES |
JILL M VISOR |
| K000297 |
04/24/2000 |
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER |
ERCHINGER MEDIZINTECNIK |
DAGMAR MASER |
| K000595 |
04/05/2000 |
DIMENSION PENTA L |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K000496 |
04/24/2000 |
EVERSHEARS BIPOLAR SCISSORS |
EVEREST MEDICAL CORP. |
FREDERICK G MADES |
| K994099 |
04/12/2000 |
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED |
EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. |
DOREEN FENG |
| K000898 |
04/14/2000 |
EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K992294 |
04/19/2000 |
BIOCERAMIC ORBITAL IMPLANT |
FCI OPHTHALMICS, INC. |
ANNE BOHSACK |
| K000448 |
04/20/2000 |
PACSSTATION |
FERNANDEZ INDUSTRIES, INC. |
ANTHONY FERNANDEZ |
| K001216 |
04/28/2000 |
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH J E PEREIRA |
| K000891 |
04/28/2000 |
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH J E PEREIRA |
| K992597 |
04/24/2000 |
LORAD LT-100 LASER TREATMENT SYSTEM |
FOCUS MEDICAL, LLC. |
JOHN LEE |
| K000106 |
04/18/2000 |
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
| K994174 |
04/20/2000 |
FRIALIT-2 MH-2 ABUTMENT |
FRIADENT GMBH |
CAROL PATTERSON |
| K000746 |
04/07/2000 |
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
| K000471 |
04/11/2000 |
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT |
FUTURE DIAGNOSTICS B.V. |
DAVE D SMITH |
| K000221 |
04/11/2000 |
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K001016 |
04/24/2000 |
GE LOGIQ 700 |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
| K000571 |
04/18/2000 |
GE LOGIQ 700 |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
| K000516 |
04/19/2000 |
GE LOGIQ 700 |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K000455 |
04/19/2000 |
GETTIG GUARD |
GETTIG PHARMACEUTICAL INSTRUMENT CO. |
JAMES A BENZ |
| K001279 |
04/28/2000 |
GT990402 DIGITAL THERMOMETER |
GLOBAL TREASURE LTD. |
BEN MA |
| K000097 |
04/12/2000 |
GSI 2000 MIDDLE EAR ANALYZER |
GRASON-STADLER, INC. |
NORMAN L SCHULTZ |
| K000793 |
04/12/2000 |
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
BYRON LAMBERT |
| K001047 |
04/28/2000 |
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
| K000858 |
04/03/2000 |
WEHRS INCUS-STAPES |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K001270 |
04/28/2000 |
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K994023 |
04/25/2000 |
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 |
HAEMACURE CORP. |
ELAINE WHITMORE |
| K000440 |
04/07/2000 |
HARDYDISK CEFTRIAXONE 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000525 |
04/07/2000 |
HARDYDISK OFLOXACIN 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000268 |
04/07/2000 |
HARDYDISK, AMPICILLIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000524 |
04/07/2000 |
HARDYDISK, CEFOTAXIME 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000526 |
04/13/2000 |
HARDYDISK, CEPHALOTHIN 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000272 |
04/07/2000 |
HARDYDISK, NITROFURANTOIN |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000261 |
04/07/2000 |
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000271 |
04/07/2000 |
HARDYDISK, SULFA/TRIMETH |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K000509 |
04/07/2000 |
HARDYDISK, VANCOMYCIN 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994027 |
04/13/2000 |
ACTIVATOR PASTE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K000127 |
04/12/2000 |
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MASER |
| K001123 |
04/21/2000 |
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
| K000603 |
04/17/2000 |
SPIFE CHOLESTEROL PROFILE KIT |
HELENA LABORATORIES |
ERIC PETERSEN |
| K000489 |
04/05/2000 |
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST |
HELIX DIAGNOSTICS, INC. |
VIRGINIA CAPPEL |
| K000629 |
04/05/2000 |
FLEXTIME |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K001019 |
04/27/2000 |
TI500 GLOBE-TROTTER TRANSPORT SYSTEM |
HILL-ROM AIR-SHIELDS |
JAMES G CARPENTER |
| K994062 |
04/10/2000 |
HMS NEUROMUSCULAR STIMULATOR |
HOME MEDICAL SERVICES, INC. |
C.A. TEKLINSKI |
| K994065 |
04/04/2000 |
MS-ONE, MODEL MS-1 |
HOME WELLNESS WEST |
RICHARD M HARRIS |
| K000080 |
04/03/2000 |
ASNIS III CANNULATED SCREW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K000725 |
04/05/2000 |
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
HWA TEH INDUSTRIAL SDN. BHD. |
K. KARUNAKARAN |
| K993695 |
04/13/2000 |
LIGA-LOOP SUTURE APPLICATOR |
HYSTERX, INC. |
JUDY F GORDON |
| K000911 |
04/14/2000 |
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 |
HYSTERX, INC. |
JUDY F GORDON |
| K001154 |
04/18/2000 |
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER |
I-STAT CORP. |
PAUL VANDERWERF |
| K991908 |
04/17/2000 |
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS |
IDEMSA |
LEON LACHMAN |
| K000195 |
04/20/2000 |
CRANIAL DRILL |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K000612 |
04/24/2000 |
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE |
INRAD |
JOSEPH M MAZUREK |
| K000151 |
04/10/2000 |
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE |
INTEGRATED ORBITAL IMPLANTS, INC. |
FLOYD G LARSON |
| K993503 |
04/14/2000 |
HAIDER-UCR SPINAL SYSTEM |
INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. |
DAVID W SCHLERF |
| K000876 |
04/18/2000 |
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K000373 |
04/14/2000 |
939UDX URINE PATHOLOGY SYSTEM |
INTL. REMOTE IMAGING SYSTEMS |
HARVEY L KASDAN |
| K000864 |
04/14/2000 |
INTRASTENT DOUBLESTRUT XS STENT |
INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K994289 |
04/17/2000 |
SUTUREGROOVE |
IOP, INC. |
JASON MALECKA |
| K000777 |
04/11/2000 |
SAMPLOK |
ITL CORPORATION, PTY LTD. |
KENNETH A PALMER |
| K000213 |
04/06/2000 |
JELDENT BASIC LINE |
J.F. JELENKO & CO. |
RAPHAEL JUDKINS |
| K000532 |
04/06/2000 |
JEL 15 |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K001094 |
04/28/2000 |
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES |
JB STAR SDN BHD |
LOOI CHIN SWEE |
| K001051 |
04/28/2000 |
RX EVEREST |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K000845 |
04/10/2000 |
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET |
JMS CO., LTD. |
KEISUKE URATOMI |
| K000843 |
04/10/2000 |
MODIFICATION TO JMS APHERESIS NEEDLE |
JMS CO., LTD. |
KEISUKE URATOMI |
| K992173 |
04/07/2000 |
SIPHONGUARD CSF CONTROL DEVICE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
LAURA O'GRADY |
| K000361 |
04/26/2000 |
K-ASSAY AT-III |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K000212 |
04/21/2000 |
KSEA CHARDONNES MORCELLATION KNIFE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K000346 |
04/14/2000 |
EZ CONNECT |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K000357 |
04/28/2000 |
EZ CONNECT RESIN |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K991677 |
04/12/2000 |
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) |
LONDON INTERNATIONAL GROUP, INC. |
BRADLEY L PUGH |
| K000826 |
04/14/2000 |
PRODIGY LATERAL VIEW SOFTWARE |
LUNAR CORP. |
JAMES P RASKOB |
| K993268 |
04/19/2000 |
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT |
MALLINCKRODT DAR S.R.L. |
GIUSEPPE TOMASINI |
| K000414 |
04/04/2000 |
MEDISUL DISPOSABLE VAGINAL SPECULUM |
MARKETING PERSPECTIVES |
JIMMIE D WILSON |
| K000192 |
04/10/2000 |
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES |
MARTIN URAM, MD |
MARTIN URAM |
| K000126 |
04/14/2000 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA |
MASIMO CORP. |
JAMES J CRONIN |
| K000985 |
04/24/2000 |
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS |
MATANG MFG. SDN. BHD. |
KOK-KEE HON |
| K991458 |
04/10/2000 |
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 |
MATSUSHITA ELECTRIC CORP. OF AMERICA |
EDWARD M BASILE |
| K001006 |
04/27/2000 |
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE |
MDS NORDION |
E S MARTELL |
| K990034 |
04/17/2000 |
WILSON-COOK COLONIC Z-STENT |
MED INSTITUTE, INC. |
NEAL E FEARNOT |
| K000824 |
04/13/2000 |
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX |
MEDAMICUS, INC. |
DENNIS MADISON |
| K000345 |
04/11/2000 |
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K000712 |
04/27/2000 |
PORTABLE INTENSIVE CARE UNIT, MODEL PIC |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K993149 |
04/28/2000 |
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS |
MEDIONICS INTERNATIONAL, INC. |
MASHESH AGARWAL |
| K991755 |
04/17/2000 |
MEDLINE TENDER WET WOUND DRESSING |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K000487 |
04/18/2000 |
MEDTRADE PRODUCTS ALGINATE ISLAND |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K994171 |
04/27/2000 |
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
JAMES BALUN |
| K000991 |
04/18/2000 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K001138 |
04/27/2000 |
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 |
MEDTRONIC VASCULAR |
MARIE HOLM |
| K993677 |
04/17/2000 |
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT |
MEDTRONIC VASCULAR |
MICHAEL HINGSON |
| K000105 |
04/12/2000 |
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), |
MEDTRONIC VASCULAR |
PAM SCHAUB |
| K000445 |
04/28/2000 |
MEDTRONIC MODEL 7499 EXTENSION |
MEDTRONIC VASCULAR |
Kathy Jo Fahey |
| K000934 |
04/07/2000 |
MDI SCL-70 TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
| K000028 |
04/04/2000 |
RENAFLO II HF 2000 HEMOFILTER |
MINNTECH CORP. |
RICHARD M ORMSBEE |
| K000061 |
04/07/2000 |
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT |
MINXRAY, INC. |
KEITH KRETCHMER |
| K000936 |
04/19/2000 |
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
MARY P LEGRAW |
| K000935 |
04/07/2000 |
KFA-63 KNEE AND FOOT ARRAY |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K000238 |
04/14/2000 |
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G |
MRL DIAGNOSTICS |
MICHAEL J WAGNER |
| K000337 |
04/12/2000 |
MTP DISPOSABLE TROCAR VALVES |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K000688 |
04/12/2000 |
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES |
N.S. UNI-GLOVES SDN. BHD. |
ROBERT D VANDER LEEK |
| K000689 |
04/28/2000 |
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES |
N.S. UNI-GLOVES SDN. BHD. |
ROBERT D VANDER LEEK |
| K001131 |
04/21/2000 |
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K001130 |
04/21/2000 |
3D MANUAL COARSE MANIPULATOR MN-188NE |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K993616 |
04/10/2000 |
CARDIO-CARD INTERPRETATION SYSTEM I |
NASIFF ASSOC., INC. |
ROGER E NASIFF |
| K000865 |
04/18/2000 |
QUIK-CAP |
NEUROSCAN |
DAVID B JONES |
| K000338 |
04/26/2000 |
VITAPORT 3 |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K000895 |
04/17/2000 |
STAT PROFILE PHOX PLUS ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K000794 |
04/10/2000 |
MODIFICATION TO MARSPO2, MODEL 2001 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN |
| K000098 |
04/12/2000 |
SOFTLINE SPRING CLIP |
NOVARE SURGICAL SYSTEMS, INC. |
TERRY BUELNA |
| K994308 |
04/18/2000 |
NUVASIVE TOWNLEY FACET SCREW |
NUVASIVE, INC. |
STEVE REITZLER |
| K000415 |
04/11/2000 |
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM |
OPTIMAL IMAGING SYSTEMS, INC. |
JORGE MILLAN |
| K992918 |
04/03/2000 |
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K993208 |
04/03/2000 |
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K001008 |
04/12/2000 |
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
| K000321 |
04/10/2000 |
HEMISPHERE MODULAR CUP SYSTEM |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K001133 |
04/24/2000 |
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE SHULMAN |
| K000797 |
04/03/2000 |
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
MELODY F MARTIN |
| K994288 |
04/10/2000 |
5.0MM SPINAL SCREWS |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K993787 |
04/14/2000 |
APPRAISE-CARDIO SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K983657 |
04/06/2000 |
OSTEONICS SERIES 7000 AD TIBIAL TRAY |
OSTEONICS CORP. |
ELIZABETH A STAUB |
| K994372 |
04/28/2000 |
MODEL 120 |
PALCO LABS, INC. |
RICHELLA GOO |
| K000828 |
04/07/2000 |
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K993756 |
04/28/2000 |
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K000224 |
04/17/2000 |
FLUROPERM 60-OK, PARAGON HDS-OK |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K000832 |
04/27/2000 |
STEROTACTIC LOCALIZATION DEVICE (SLD) |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER A LTMAN |
| K000223 |
04/14/2000 |
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE |
PHOENIX MEDICAL TECHNOLOGY, INC. |
GROVER C MIXON |
| K000428 |
04/28/2000 |
DIXI 2 |
PLANMECA OY |
LARS MORING |
| K000163 |
04/18/2000 |
PM 2002 PROLINE/AEC |
PLANMECA OY |
LARS MORING |
| K992154 |
04/06/2000 |
BICON-PLUS ACETABULAR COMPONENTS |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K000227 |
04/27/2000 |
UMBICUT |
POLLAK (INTL.), LTD. |
MICHAEL PORAT |
| K972610 |
04/11/2000 |
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C |
POSSIS MEDICAL, INC. |
JAMES D GUSTAFSON |
| K993564 |
04/28/2000 |
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 |
POSSIS MEDICAL, INC. |
TIMOTHY J KAPPERS |
| K000444 |
04/21/2000 |
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM |
PRISM ENTERPRISES, INC. |
JUDITH A HARBOUR |
| K000135 |
04/10/2000 |
PRO.DUCT CATHETER, MODEL CTH03 |
PRO.DUCT HEALTH, INC. |
ANGELA B SOITO |
| K000667 |
04/28/2000 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM |
PROTECTION GLOVES SDN. BHD. |
THIRUNAVUKARASU PEARIASAMY |
| K000668 |
04/28/2000 |
POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA |
PROTECTION GLOVES SDN. BHD. |
THIRUNAVUKARASU PEARIASAMY |
| K993414 |
04/07/2000 |
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 |
PRUCKA ENGINEERING, INC. |
MATTHEW W PRUCKA |
| K993272 |
04/10/2000 |
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM |
PURE WATER, INC. |
CYNTHIA P WALTERS |
| K000443 |
04/24/2000 |
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM |
R4 TELEMEDICINE, INC. |
THOMAS B SMITH |
| K982556 |
04/06/2000 |
LEVEEN NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K000241 |
04/14/2000 |
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR |
RADIOTHERAPEUTICS CORP. |
GARY CURTIS |
| K000375 |
04/05/2000 |
RANDOX CALCIUM |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K000662 |
04/03/2000 |
RANDOX FERRITIN |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K000661 |
04/13/2000 |
RANDOX PREALBUMIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K001102 |
04/20/2000 |
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E |
RD MEDICAL MFG., INC. |
CARLOS A RODRIGUEZ-GARCIA |
| K000979 |
04/10/2000 |
REDI-SCREEN |
REDWOOD BIOTECH, INC. |
JANIS FREESTONE |
| K001048 |
04/27/2000 |
LIGHT BOND (QUICK CURE) |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
KATHRYN B PATTERSON |
| K001025 |
04/19/2000 |
LIFECARD CF COMPACT RECORDER |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
| K000406 |
04/17/2000 |
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE |
RHINOMETRICS A/S |
HOWARD M HOLSTEIN |
| K000534 |
04/05/2000 |
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K001015 |
04/27/2000 |
ELECSYS THYROGLOBULIN CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K994164 |
04/13/2000 |
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994165 |
04/07/2000 |
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K000096 |
04/26/2000 |
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K000205 |
04/19/2000 |
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES |
ROCKET MEDICAL PLC |
LES TODD |
| K000340 |
04/19/2000 |
HYSTALOG HSG CATHETER |
ROCKET MEDICAL PLC |
L. TODD |
| K000049 |
04/04/2000 |
SUNI MAX |
SATELEC |
JACQUELINE E MASSE |
| K000868 |
04/20/2000 |
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES |
SGMP CO., LTD. |
CHEAH CHOR HEE |
| K000867 |
04/21/2000 |
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR |
SGMP CO., LTD. |
CHEAH CHOR HEE |
| K000391 |
04/12/2000 |
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K000390 |
04/12/2000 |
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K000872 |
04/05/2000 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K000953 |
04/20/2000 |
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K000670 |
04/12/2000 |
NITRILE EXAM GLOVE, POWDER FREE, BLUE |
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. |
JANNA P TUCKER |
| K000584 |
04/12/2000 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. |
JANNA P TUCKER |
| K000398 |
04/17/2000 |
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 |
SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K000323 |
04/05/2000 |
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
JOY LANCASTER |
| K000330 |
04/05/2000 |
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
JOY LANCASTER |
| K000329 |
04/05/2000 |
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
JOY LANCASTER |
| K000528 |
04/07/2000 |
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K000527 |
04/07/2000 |
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K000942 |
04/27/2000 |
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 |
SIMS DELTEC, INC. |
LISA STONE |
| K993619 |
04/28/2000 |
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
| K993092 |
04/14/2000 |
SONADA ULTRASOUND SYSTEM |
SONOVISION CORP. |
PAUL SCHNEIDER |
| K993027 |
04/06/2000 |
ESKA MODULAR HIP SYSTEM |
SPECS USA, INC. |
THOMAS P MONKUS |
| K000411 |
04/14/2000 |
CHILI VIDEO, CHILI VIDEOPRO |
STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK |
JIM DOYLE |
| K000113 |
04/04/2000 |
PROVEN KNEE SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
| K000941 |
04/06/2000 |
STERLTECH WATER PURIFIER |
STERLTECH, INC. |
JOHN R NOLL |
| K000945 |
04/18/2000 |
PARA 12 PLUS RETICS |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K993492 |
04/21/2000 |
DEVILBISS NEBULIZER MODEL 800 |
SUNRISE MEDICAL HHG, INC. |
FRANK CLEMENTI |
| K000408 |
04/19/2000 |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM |
SURETEX PROPHYLACTICS LTD. |
LON D MCINVAIN |
| K000954 |
04/28/2000 |
KERR GEL ETCHANT |
SYBRON DENTAL SPECIALTIES, INC. |
ORLANDO TADEO, JR. |
| K000684 |
04/28/2000 |
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K000558 |
04/14/2000 |
SYNTHES (USA) WRIST FUSION PLATES (WFP) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K000555 |
04/12/2000 |
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O |
TEKMEDIC (M) SDN BHD |
KOK-KEE HON |
| K992664 |
04/13/2000 |
TFX MEDICAL STYLET CATHETER |
TFX MEDICAL GROUP |
JULIE A BEAUMONT |
| K000701 |
04/27/2000 |
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K000549 |
04/20/2000 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K000222 |
04/19/2000 |
UM-L25 |
UNION MEDICAL ENGENEERING CO., LTD. |
ANNIE VELEZ |
| K000194 |
04/10/2000 |
DIGITAL INFLECTION RIGIDOMETER (DIR) |
UROAN XXI ELECTROMEDICINA |
VICTORIA GAYA |
| K000507 |
04/21/2000 |
CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
| DEN000006 |
04/28/2000 |
EROS-CLITORAL THERAPY DEVICE (CTD) |
UROMETRICS, INC. |
PHILIP A MESSINA |
| K000437 |
04/14/2000 |
INTERVENTIONAL BODY COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K992942 |
04/13/2000 |
LEMAITRE OCCLUSION CATHETER |
VASCUTECH, INC. |
TRENT G KAMKE |
| K000412 |
04/24/2000 |
VISION R/F TILTING TABLE |
VILLA SISTEMI MEDICALI S.P.A. |
JEFFERY N MOELLER |
| K000441 |
04/11/2000 |
BODYGUARD |
VITAL SIGNS, INC. |
ANTHONY MARTINO |
| K000557 |
04/24/2000 |
MEDVIZER PACS, MODEL RELEASE 2000 |
VITEL NET |
ALLEN IZADPANAH |
| K993925 |
04/03/2000 |
WAKO L-TYPE UN TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K000768 |
04/11/2000 |
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
| K000051 |
04/05/2000 |
ACTICOAT FOAM DRESSING |
WESTAIM BIOMEDICAL, INC. |
Steve Chartier |
| K000971 |
04/14/2000 |
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K991060 |
04/06/2000 |
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 |
ZCV ,INC. |
PRISCILLA WHITEHEAD COX |
