| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K001547 |
08/07/2000 |
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP |
AB BIODISK |
ANNE BOLMSTROM |
| K002006 |
08/10/2000 |
LIFESHIELD ADDITIVE PIERCING PIN |
ABBOTT LABORATORIES |
THOMAS P SAMPOGNA |
| K002401 |
08/29/2000 |
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) |
ADVANCED STERILIZATION PRODUCTS |
NEELU MEDHEKER |
| K992831 |
08/25/2000 |
AERONEB II, MODEL APN 200 |
AEROGEN, INC. |
TRACI V. A EDWARDS |
| K002009 |
08/02/2000 |
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K002397 |
08/17/2000 |
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER |
AGILENT TECHNOLOGIES, INC. |
PAUL SMOLENSKI |
| K001467 |
08/01/2000 |
DA VINCHI EMG/EP ISA1004EP |
AIRSEP CORP. |
PETER WEISENBORN |
| K001579 |
08/31/2000 |
IMPULSE SELECT |
AIRSEP CORP. |
JAMES A ALESSI |
| K993524 |
08/01/2000 |
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K001126 |
08/07/2000 |
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST |
ALATEX SCIENTIFIC, INC. |
JANIS FREESTONE |
| K994395 |
08/07/2000 |
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994399 |
08/04/2000 |
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994403 |
08/14/2000 |
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994400 |
08/04/2000 |
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994406 |
08/14/2000 |
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K002419 |
08/15/2000 |
SURGICAL DRAPES |
ALLEGIANCE HEALTHCARE COPORATION |
SHARON ROBBINS |
| K983299 |
08/04/2000 |
ALLEGIANCE GENESIS CONTAINER SYSTEM |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K000788 |
08/04/2000 |
APEX MODULAR HIP STEM |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K001420 |
08/30/2000 |
SLIDESCAN |
APPLIED IMAGING CORP. |
DIANE OATES |
| K991971 |
08/04/2000 |
ARTHREX CHONDRAL DART, MODEL AR-4005B-18 |
ARTHREX, INC. |
VERNON C BROWN |
| K001588 |
08/17/2000 |
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K001250 |
08/16/2000 |
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) |
ASAHI MEDICAL CO., LTD. |
DAVID L WEST |
| K001815 |
08/10/2000 |
DC ZIRKON |
AUSTENAL, INC. |
RONALD DUDEK |
| K001799 |
08/10/2000 |
DC-TELL |
AUSTENAL, INC. |
RONALD DUDEK |
| K001731 |
08/29/2000 |
AVID-NIT LOSS OF RESISTANCE SYRINGE |
AVID MEDICAL, INC. |
SEAN F SHEMANSKI |
| K001981 |
08/21/2000 |
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 |
AXIS-SHIELD LTD. |
EILEEN MCCAFFERTY |
| K002435 |
08/24/2000 |
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K002085 |
08/01/2000 |
ULTRASOUND SCANNER, TYPE 1101 |
B & K MEDICAL A/S |
VILLY BRAENDER |
| K001571 |
08/04/2000 |
BAUMER FEMORAL HEAD |
BAUMER S.A. |
BRENO C FARAGO, JR. |
| K001935 |
08/22/2000 |
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 |
BECKMAN COULTER, INC. |
ANGELA M BYLAND |
| K002453 |
08/31/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 |
BECKMAN COULTER, INC. |
JAN OLSEN |
| K002109 |
08/31/2000 |
OLEEVA FOAM |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K002535 |
08/30/2000 |
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 |
BIO-RAD |
ELIZABETH PLATT |
| K002120 |
08/21/2000 |
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 |
BIO-RAD |
ELIZABETH PLATT |
| K002536 |
08/30/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) |
BIO-RAD |
ELIZABETH PLATT |
| K002460 |
08/31/2000 |
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 |
BIO-RAD |
ELIZABETH PLATT |
| K002196 |
08/07/2000 |
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 |
BIO-RAD |
ELIZABETH PLATT |
| K002070 |
08/25/2000 |
BIOLOK SCREW |
BIOCOMPOSITES LTD. |
J.STEPHEN BRATT |
| K001724 |
08/04/2000 |
STIMULAN -CALCIUM SULFATE BONE VOID FILTER |
BIOCOMPOSITES LTD. |
STEPHEN BRATT |
| K002020 |
08/25/2000 |
LACTOSORB MENISCAL SCREW |
BIOMET MANUFACTURING, INC. |
MARY VERSTYNEN |
| K001580 |
08/17/2000 |
GROSS FEMORAL COMPONENT |
BIOMET, INC. |
TINA LAKIN |
| K984390 |
08/07/2000 |
LACTOSORB PANELS AND FASTENERS |
BIOMET, INC. |
TRACY J BICKEL |
| K002379 |
08/31/2000 |
M2A 28MM RINGLOC LINER |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K001760 |
08/31/2000 |
RADIOLUCENT COLLES FRACTURE KIT |
BIOMET, INC. |
TRACY J BICKEL |
| K002333 |
08/31/2000 |
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 |
BIOSENSE WEBSTER, INC. |
MARIA D OCHOA |
| K001736 |
08/02/2000 |
GALEO HYDRO AND GALEO HYDRO J-TIP |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K001727 |
08/09/2000 |
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES |
BLEASE MEDICAL EQUIPMENT LTD. |
ART WARD |
| K993875 |
08/11/2000 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM |
BOSTON MEDICAL TECHNOLOGIES, INC. |
CESIDIO TEMPESTA |
| K001134 |
08/31/2000 |
GAZELLE BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K001338 |
08/30/2000 |
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
ABBY LIPMAN |
| K994155 |
08/03/2000 |
EXCELSIOR 1018 MICROCATHETER |
BOSTON SCIENTIFIC, TARGET |
ROXANNE K BAXTER |
| K002181 |
08/11/2000 |
GDC ULTRASOFT COIL |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K001743 |
08/25/2000 |
ULTIMA SMARTBELT, MODEL 0560 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K002321 |
08/14/2000 |
PAIN CARE 2000L |
BREG, INC. |
KATHLEEN BARBER |
| K002351 |
08/26/2000 |
FLUOROTEX II SURGICAL MESH |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
| K002205 |
08/10/2000 |
CARONY |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD KELLER |
| K002063 |
08/10/2000 |
BIOTRACE, MODEL 1730 |
BRYAN CORP. |
ROSE S LOGSDON |
| K001803 |
08/04/2000 |
ACCELERATOR RECIPROCATING CANNULA |
BYRON MEDICAL |
REGINA S HARRIS |
| K000983 |
08/26/2000 |
CERAMIX PORCELAIN SYSTEM |
C-MIX |
ART WARD |
| K002230 |
08/18/2000 |
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K001589 |
08/18/2000 |
CANDELA DYNAMIC COOLING DEVICE |
CANDELA CORP. |
JOAN M CLIFFORD |
| K001462 |
08/21/2000 |
CARESIDE HEMOGLOBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K002174 |
08/22/2000 |
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 |
CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) |
KAREN HICKEY |
| K001975 |
08/04/2000 |
CERALAS D10 810NM LASER, MODEL CERALAS D10-60 |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K000859 |
08/23/2000 |
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 |
CHARLES A. SMITH |
CHARLES A SMITH |
| K000685 |
08/15/2000 |
CHARTER MEDICAL NEONATAL SYRINGE SET |
CHARTER MEDICAL, LTD. |
K. ALICE PREVILLE |
| K001662 |
08/02/2000 |
CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
DAVE HERNON |
| K001858 |
08/17/2000 |
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE |
CHINA NANTONG GUANGDA TEXTILE CO., LTD. |
YONG ZHANG |
| K993806 |
08/14/2000 |
DIALGUARD ENDOTOXIN REMOVAL DEVICE |
CLARIGEN, INC. |
EDIT HEGYI |
| K000388 |
08/08/2000 |
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) |
CLEARWATER COLON HYDROTHERAPY, INC. |
STUART K BAKER |
| K992905 |
08/01/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM |
Codman & Shurtleff, Inc. |
JAMES M FLAHERTY |
| K001598 |
08/22/2000 |
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION |
COL-BAR LTD. |
JOHNATHAN S KAHAN |
| K002065 |
08/22/2000 |
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
CHEE Y FOO |
| K993140 |
08/02/2000 |
WATER FOR TISSUE CULTURE, MODELS 1500 |
CONCEPTION TECHNOLOGIES |
GREG HOLLAND |
| K001300 |
08/30/2000 |
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS |
CONFECTION MEDICALE D.R., INC. |
GUY HOUDE |
| K002002 |
08/17/2000 |
SUREFIT DISPERSIVE ELECTRODE |
CONMED CORP. |
IRA D DUESLER, JR. |
| K000251 |
08/30/2000 |
SPECTRUM SILICONE FOLEY CATHETER |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
| K001704 |
08/31/2000 |
ATHOS |
COSMOS MEDICAL TECHNOLOGY |
JOHN CLARK |
| K002190 |
08/10/2000 |
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) |
CP MEDICAL |
PATRICK FERGUSON |
| K001106 |
08/16/2000 |
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 |
CREATIVE PLASTIC TECHNOLOGY |
ROBERT J BARD |
| K002388 |
08/25/2000 |
EHC500 DESKTOP PATIENT STATION, MODEL EHC500 |
CYBERCARE, INC. |
J. TERRY DRURY |
| K001645 |
08/04/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K002365 |
08/25/2000 |
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET |
DATASCOPE CORP. |
JOANN WOLF |
| K001814 |
08/23/2000 |
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
| K002298 |
08/24/2000 |
SUPER 1 |
DENTAL ALLOY PRODUCTS, INC. |
RODNEY GUYTON |
| K001470 |
08/04/2000 |
E-Z LINK CROSS CONNECTOR |
DEPUY ACROMED |
KAREN F JURCZAK |
| K001991 |
08/25/2000 |
TITAN POROCOAT HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K001523 |
08/10/2000 |
ULTIMA METAL-ON-METAL ACETABULAR CUP |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K001922 |
08/29/2000 |
DEPUY NEUFLEX PIP FINGER |
DEPUY, INC. |
JANET G JOHNSON |
| K990517 |
08/01/2000 |
EXPLORER CVS TRANSCRANIAL DOPPLER |
DIAGNOSTIC MEDICAL SYSTEMS |
FRANK FERGUSON |
| K001767 |
08/07/2000 |
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K001875 |
08/21/2000 |
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K002086 |
08/17/2000 |
PRIMAFLOW |
DMG USA, INC. |
PAMELA PAPINEAU |
| K000475 |
08/22/2000 |
BRACHYSEED |
DRAXIMAGE, INC. |
R.J. FLANAGAN |
| K000204 |
08/01/2000 |
WIN-1 TANGO |
DURACARE MEDICAL EQUIPMENT, L.C. |
ROBERT S MCQUATE |
| K001994 |
08/04/2000 |
EEI SLUSH PAN DRAPE |
EAGLE ENDOSCOPIC, INC. |
JOHN MAYALL |
| K001565 |
08/10/2000 |
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB |
EDWARDS LIFESCIENCES, LLC. |
JOHN W SMITH |
| K001847 |
08/24/2000 |
ANTERIOR CERVICAL PLATE SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA MONAHON |
| K002223 |
08/22/2000 |
EPIC SPO2 FINGER SENSOR, MODEL E412-20 |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K002364 |
08/10/2000 |
PROTEMP H |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K002141 |
08/16/2000 |
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT |
EXACTECH, INC. |
Lisa Simpson |
| K000919 |
08/31/2000 |
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K001496 |
08/01/2000 |
A.V. FISTULA NEEDLE |
EXELINT INTERNATIONAL CO. |
ARMAND HAMID |
| K002129 |
08/25/2000 |
FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN |
FERRIS MFG. CORP. |
THEODORE THORSEN |
| K991522 |
08/04/2000 |
MICROTARGETING ELECTRODE |
FHC, INC. |
FREDERICK HAER |
| K000158 |
08/24/2000 |
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 |
FISMA, INC. |
DOUGLAS A KANE |
| K001810 |
08/14/2000 |
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING |
FLEXSITE DIAGNOSTICS, INC. |
DONALD R STONE |
| K991495 |
08/28/2000 |
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS |
FLUID PROCESS SYSTEMS, INC. |
STEPHEN C HAMBRIC |
| K002277 |
08/25/2000 |
FRESENIUS OPTIFLUX 200NR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K001823 |
08/16/2000 |
LINKMAX |
GC AMERICA, INC. |
TERRY L JORITZ |
| K001946 |
08/30/2000 |
NEUROVASCULAR ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K970569 |
08/14/2000 |
BIO-BLOCKS |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
| K001923 |
08/25/2000 |
REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 |
GENDRON, INC. |
FREDERIC W STROBEL |
| K002209 |
08/18/2000 |
GE MARQUETTE ECG ANALYSIS PROGRAM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KRISTIN PABST |
| K002340 |
08/22/2000 |
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW |
GLORMED INTL., INC. |
JANNA P TUCKER |
| K000736 |
08/08/2000 |
LA JOIE |
GOOMI EHWA, INC. |
MANOH PARK |
| K002206 |
08/24/2000 |
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO |
GUIDANT CORP. |
MARGARET ANDERSON |
| K994118 |
08/14/2000 |
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS |
GUILIN LATEX FACTORY |
PETER WEI |
| K002021 |
08/24/2000 |
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K002378 |
08/29/2000 |
MODULAR PORP AND TORP MODEL TBD |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K002464 |
08/29/2000 |
SMITH & NEPHEW OFF-CENTERED PORP |
GYRUS ENT L.L.C. |
ALICIA FARAGE |
| K000913 |
08/10/2000 |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
HANDSAFE PRODUCTS SDN. BHD. |
NG KOK HWA |
| K001456 |
08/07/2000 |
CONSENSUS KNEE SYSTEM |
HAYES MEDICAL, INC. |
WILLIAM J GRIFFIN |
| K002221 |
08/09/2000 |
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
| K000084 |
08/04/2000 |
ENRAF-NONIUS SONOPULS 190 SYSTEM |
HENLEY HEALTHCARE, INC. |
REBECCA STOUT |
| K001860 |
08/10/2000 |
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA |
HOMEDICS, INC. |
MICHEAL NELSON |
| K001614 |
08/04/2000 |
STRYKER TRAUMA PELVIC SET |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K001449 |
08/04/2000 |
TRIDENT ACETABULAR SHELLS: PS |
HOWMEDICA OSTEONICS CORP. |
TERRY S POWELL |
| K001448 |
08/04/2000 |
TRIDENT ACETABULAR SHELLS: PS-HA |
HOWMEDICA OSTEONICS CORP. |
TERRY S POWELL |
| K001653 |
08/18/2000 |
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K001615 |
08/18/2000 |
HUNTER SCIENTIFIC INJECTION PIPETTES |
HUNTER SCIENTIFIC LIMITED |
MARK RAWE |
| K001677 |
08/14/2000 |
BABY DOPPLEX 4000 (BD4000) |
HUNTLEIGH DIAGNOSTICS LTD. |
B. J COLLEYPRIEST |
| K001409 |
08/02/2000 |
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER |
HYPERBARIC TECHNOLOGIES, INC. |
PAUL E DRYDEN |
| K001759 |
08/24/2000 |
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ |
IMPLEX CORP. |
JOHN SCHALAGO |
| K001471 |
08/07/2000 |
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ |
IMPLEX CORP. |
JOHN A SCHALAGO |
| K984570 |
08/30/2000 |
MINOLTA PULSOX-3/MINOLTA PULSOX-3I |
IN-X CORP. |
CHARLIE HENRY |
| K993913 |
08/09/2000 |
TRUE |
INFINITY EXTRUSION & ENGINEERING, INC. |
DOUGLAS WILKINS |
| K994109 |
08/03/2000 |
DETRUSAN 500 |
INNOVAMED USA, INC. |
E.H. CZADILEK |
| DEN000007 |
08/16/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K001928 |
08/02/2000 |
SIGMA |
INSTRUMENTARIUM IMAGING, INC. |
DOUG WOODS |
| K002400 |
08/30/2000 |
MODIFICATION OF ACL ADVANCE |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K001648 |
08/28/2000 |
INTRASTENT DOUBLESTRUT PARAMOUNT |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
| K001666 |
08/24/2000 |
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
DAVID CASAL |
| K002171 |
08/10/2000 |
INVACARE LIFT CHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K002317 |
08/25/2000 |
MODEL 9000 BARIATRIC WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K002170 |
08/04/2000 |
MODEL 9000 PEDIATRIC WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K002157 |
08/25/2000 |
RANGER II M6, MODEL IN-888WNL |
INVACARE CORP. |
HOWARD M HOLSTEIN |
| K001967 |
08/14/2000 |
PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K001410 |
08/01/2000 |
PHORESOR MODEL PM2000 |
IOMED, INC. |
W. TIM MILLER |
| K002048 |
08/30/2000 |
JBC OPAQUE AND GLITTER |
J.B.C AND CO. |
PRISCILLA L MIER |
| K002222 |
08/31/2000 |
RD-2104 |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K002041 |
08/16/2000 |
WILLI GELLER CREATION & AV PORCELAIN |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K991864 |
08/31/2000 |
ROTAFLOW CENTRIFUGAL PUMP SYSTEM |
JOSTRA MEDIZINTECHNIK AG |
KATHY JOHNSON |
| K001740 |
08/22/2000 |
KSEA MONOPOLAR VAPORIZATION ELECTRODES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K002202 |
08/25/2000 |
KARMAN WHEELCHAIR |
KARMAN HEALTHCARE, INC. |
ALEX C HORNG |
| K002167 |
08/25/2000 |
KARMAN WHEELCHAIR |
KARMAN HEALTHCARE, INC. |
ALEX C HORNG |
| K001655 |
08/10/2000 |
PERMLASTIC 2 |
KERR CORP. |
COLLEEN BOSWELL |
| K002239 |
08/08/2000 |
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM |
KONTRON MEDICAL SYSTEMS SAS |
GEORGE MYERS |
| K001908 |
08/18/2000 |
KONTUR 55 SOFT LENS |
KONTUR KONTACT LENS CO., INC. |
KEVIN M RANDALL |
| K001914 |
08/10/2000 |
CLEARFIL REPAIR |
KURARAY COMPANY, LTD. |
KOICHI KIKUCHI |
| K001913 |
08/04/2000 |
CLEARFIL ST OPAQUER |
KURARAY COMPANY, LTD. |
KOICHI K IKUCHI |
| K002200 |
08/25/2000 |
CAPELLA |
MADSEN ELECTRONICS, INC. |
JIM BERGERSON |
| K002138 |
08/29/2000 |
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 |
MAERSK MEDICAL A/S |
JENNIFER LYONS |
| K001162 |
08/09/2000 |
GOLDFINGER DEVICE |
MALI-TECH LTD. |
AHAVA STEIN |
| K001609 |
08/10/2000 |
MALLARD AIR OXYGEN ACCUBLENDER |
MALLARD MEDICAL, INC. |
ROBERT PEARSON |
| K994124 |
08/11/2000 |
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES |
MAPA PROFESSIONAL |
ALEJANDRO SANCHEZ |
| K002279 |
08/18/2000 |
ML EYE SPEAR, MODEL ML 27 ES |
MED-LOGICS, INC. |
GARY MOCNIK |
| K001052 |
08/30/2000 |
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX |
MED-TEC,INC. |
DONALD F RIIBE |
| K002287 |
08/25/2000 |
WIZAIR COMPRESSION SYSTEM |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
SHOSHANA FRIEDMAN |
| K002116 |
08/09/2000 |
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 |
MEDICAL DEVICE CONSULTANTS, INC. |
CYNTHIA J NOLTE |
| K002100 |
08/25/2000 |
XIMX SYSTEM |
MEDICAL MANAGER RESEARCH DEVELOPMENT |
JEFFREY K SHAPIRO |
| K994283 |
08/30/2000 |
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K002185 |
08/01/2000 |
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
GARY J ALLSEBROOK |
| K002491 |
08/25/2000 |
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS |
MEDISON CO., LTD. |
GARY J ALLSEBROOK |
| K001498 |
08/10/2000 |
THE FUGO BLADE |
MEDISURG LTD. |
RICHARD J FUGO |
| K993042 |
08/17/2000 |
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT |
MEDIVATORS, INC. |
NORMAN MINER |
| K001404 |
08/08/2000 |
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON |
MEDNET LOCATOR, INC. |
JUDY CHANDLER |
| K001406 |
08/08/2000 |
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES |
MEDNET LOCATOR, INC. |
JUDY CHANDLER |
| K001969 |
08/16/2000 |
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K001898 |
08/31/2000 |
VASOTRAX |
MEDWAVE, INC. |
DONNA R LUNAK |
| K000593 |
08/04/2000 |
SONIC, MODEL SO-100 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
| K001940 |
08/11/2000 |
MICOR ANESTHESIA CONDUCTION KIT |
MICOR, INC. |
JEREMIAH COSTELLO |
| K002212 |
08/03/2000 |
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 |
MICRO THERAPEUTICS, INC. |
MARIBELLE AGUINALDO |
| K000969 |
08/22/2000 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K001182 |
08/01/2000 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K001829 |
08/18/2000 |
MINIMED PARADIGM INSULIN PUMP, MODEL 511 |
MINIMED, INC. |
JENNIFER LYONS |
| K001828 |
08/18/2000 |
PARADIGM 1.5ML RESERVOIR, MODEL 326 |
MINIMED, INC. |
JENNIFER LYONS |
| K001827 |
08/18/2000 |
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 |
MINIMED, INC. |
JENNIFER LYONS |
| K001832 |
08/18/2000 |
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 |
MINIMED, INC. |
JENNIFER LYONS |
| K000355 |
08/23/2000 |
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR |
MINNESOTA MINING AND MFG. CO. |
GRETCHEN KEENAN |
| K002402 |
08/31/2000 |
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM |
MITEK PRODUCTS |
MARY P LEGAW |
| K002422 |
08/31/2000 |
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
MARY P LEGRAW |
| K993698 |
08/16/2000 |
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
| K001944 |
08/14/2000 |
HAC-300 HEAD ARRAY COIL |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K002539 |
08/30/2000 |
OBC-096 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K001903 |
08/29/2000 |
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM |
NEOTONUS, INC. |
SHEILA HEMEON-HEYER |
| K001562 |
08/16/2000 |
NEURO SCAN MEDICAL SYSTEMS A4000 |
NEURO SCAN LABS |
DAVID B JONES |
| K002347 |
08/17/2000 |
COOLTOUCH II |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K992133 |
08/04/2000 |
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL |
NEWPORT MEDICAL INSTRUMENTS, INC. |
ROBERT W DICK |
| K001091 |
08/10/2000 |
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 |
NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. |
JUAN OMAR PEREZ |
| K993950 |
08/23/2000 |
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 |
NIEN MADE ELECTRNICS CORP. |
JAMES M DELANEY |
| K000517 |
08/31/2000 |
LIFE SCOPE EC, MODEL BSM-1102 |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K002260 |
08/25/2000 |
SPINA SYSTEM |
NORTH AMERICAN MEDICAL CORPORATION (NAM) |
CARLOS BECERRA |
| K001325 |
08/18/2000 |
FLO ASSISTANT, MODEL 4-250-00 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K001761 |
08/07/2000 |
STATLYTE NA/K/CL/LI ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K993788 |
08/04/2000 |
R.TEST EVOLUTION |
NOVACOR DIV. |
LYNETTE L HOWARD |
| K000718 |
08/24/2000 |
CHROMOSTREAK |
NOVAMED LTD. |
GERALD M SLUTZKY |
| K001560 |
08/24/2000 |
ODONTOSURGE 3 |
ODONTO-WAVE |
JAMES DIEROFF |
| K002313 |
08/30/2000 |
COMPLEXED PSA MICROTITER ELISA |
ONCOGENE SCIENCE, INC. |
SHERYL BROWN-SHIMER |
| K002121 |
08/30/2000 |
TOTAL PSA MICROTITER ELISA |
ONCOGENE SCIENCE, INC. |
SHERYL BROWN-SHIMER |
| K001773 |
08/18/2000 |
ORTHONE |
ONI, INC. |
MICHAEL A DOUGLAS |
| K002053 |
08/03/2000 |
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 |
ORTHOSOFT, INC. |
NICOLE LANDREVILLE |
| K994022 |
08/31/2000 |
PARALLAX CRANIOSET |
PARALLAX MEDICAL, INC. |
SUSAN MARQUES |
| K002195 |
08/30/2000 |
FORAMATRON V, MODEL D680 |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K001887 |
08/09/2000 |
MODIFICATION TO PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLION |
| K001721 |
08/04/2000 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K001953 |
08/10/2000 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K002314 |
08/17/2000 |
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHANG |
| K002114 |
08/11/2000 |
RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
| K002112 |
08/14/2000 |
RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NEING CHOON |
| K002415 |
08/18/2000 |
POWERDRIVE 350 OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE PRASCHAN |
| K001709 |
08/31/2000 |
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 |
PIONEER SURGICAL TECHNOLOGY |
AMY H MOMMAERTS |
| K001909 |
08/25/2000 |
PLAINSENSE WHEELCHAIR |
PLAINSENSE WHEELCHAIRS, INC. |
|
| K001960 |
08/28/2000 |
RIGID GAS PERMEABLE CONTACT LENS |
POLYMER TECHNOLOGY |
DEBRA L.B. KETCHUM |
| K002240 |
08/23/2000 |
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 |
PRECISION THERAPY INTL., INC. |
PAUL SUMNER |
| K001808 |
08/04/2000 |
DORO HEADREST SYSTEM |
PRO-MED INSTRUMENTS GMBH |
ANITA THIBEAULT |
| K001392 |
08/21/2000 |
GLYCOSAL HBA1C TEST |
PROVALIS DIAGNOSTICS LTD. |
TOM TSAKERIS |
| K000888 |
08/15/2000 |
SANSIBAR CPAP SYSTEM |
PRYM MEDICAL LTD. |
SHOSHANA FRIEDMAN |
| K000653 |
08/04/2000 |
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 |
PULMONOX MEDICAL CORP. |
PAULA TOMAT |
| K002319 |
08/30/2000 |
PURILENS SALINE SOLUTION |
PURILENS, INC. |
ART WARD |
| K001492 |
08/09/2000 |
QUINTON Q-STRESS, MODEL 000483 |
QUINTON, INC. |
DAVID HIMES |
| K001414 |
08/09/2000 |
KWIKKMODEL |
R-DENTAL DENTALERZEUGNISSE GMBH |
ANDREAS SPRAFKE |
| K992226 |
08/04/2000 |
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
RADIONICS, INC. |
KEVIN J O'CONNELL |
| K001009 |
08/04/2000 |
RANDOX C-REACTIVE PROTEIN |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K993389 |
08/18/2000 |
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993409 |
08/18/2000 |
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
| K993403 |
08/18/2000 |
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
| K000808 |
08/25/2000 |
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE |
RICH-MAR CORP. |
DAVID RICHARDS |
| K002353 |
08/10/2000 |
ELECSYS CA 15-3 CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K002148 |
08/22/2000 |
ELECSYS HCG TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K000568 |
08/04/2000 |
HDL CHOLESTEROL PLUS |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K001641 |
08/03/2000 |
TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
| K000114 |
08/10/2000 |
RS-4M+MUSCLE STIMULATOR |
RS MEDICAL |
JOEL S FADEN |
| K001943 |
08/23/2000 |
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY |
SANGUI BIOTECH, INC. |
JOHN J KIANG |
| K000209 |
08/18/2000 |
DOSE 1 |
SCANDITRONIX WELLHOFER NORTH AMERICA |
CHUCK LINDLEY |
| K001411 |
08/21/2000 |
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
| K002107 |
08/04/2000 |
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. |
SCIMEDX CORP. |
GARY LEHNUS,PH.D |
| K002134 |
08/07/2000 |
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
CAROL A ADILETTO, M.S. |
| K000700 |
08/31/2000 |
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR |
SENSIDYNE, INC. |
HOWARD MILLS |
| K002218 |
08/15/2000 |
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K002217 |
08/11/2000 |
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K002220 |
08/15/2000 |
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K002216 |
08/11/2000 |
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA T TUCKER |
| K001077 |
08/02/2000 |
LUBRIGEL PERSONAL LUBRICANT |
SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC |
KATHLEEN HACKU |
| K002015 |
08/09/2000 |
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| K002012 |
08/09/2000 |
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| K994231 |
08/10/2000 |
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) |
SIEMENS MEDICAL CORP. |
MALGORZATA STANEK |
| K001400 |
08/01/2000 |
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDI HOFFMAN |
| K002225 |
08/08/2000 |
OR TABLE/MAGNETOM OPEN VIVA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K002528 |
08/31/2000 |
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION |
SIENCO, INC. |
BARBARA DEBIASE |
| K001403 |
08/10/2000 |
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K001764 |
08/09/2000 |
HOTLINE 2 FLUID WARMER |
SIMS LEVEL 1, INC. |
GABRIEL J MURACA JR. |
| K001555 |
08/02/2000 |
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 |
SIMS PORTEX LTD. |
STEVEN M OGILVIE |
| K000811 |
08/25/2000 |
NLITE SYSTEM, SLS MODEL NUMBER A00-1025 |
SLS BIOPHILE LTD. |
MICHAEL KIERNAN |
| K001681 |
08/25/2000 |
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM |
SMV AMERICA |
FRANCOIS ROCHE |
| K001604 |
08/14/2000 |
DANA DIABECARE |
SOOIL DEVELOPMENT CO., LTD. |
CYNTHIA J NOLTE |
| K002434 |
08/23/2000 |
PALM PUMP |
SORENSON MEDICAL, INC. |
R. DOUGLAS JACOB |
| K002533 |
08/30/2000 |
TCD 100M, PWD13 TRANSDUCER |
SPENCER TECHNOLOGIES |
TONY WILLIAMS |
| K001476 |
08/04/2000 |
TORQUE INSTRUMENT, MODEL 8500 |
SPINALIGHT, INC. |
T. A COX |
| K000421 |
08/14/2000 |
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE |
SSL AMERICAS, INC. (REGENT MEDICAL) |
BRADLEY L PUGH |
| K000605 |
08/17/2000 |
STACKHOUSE LENS HOOD, MODEL SA-700/F |
STACKHOUSE, INC. |
TOM GUTIERREZ |
| K001825 |
08/02/2000 |
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K002281 |
08/17/2000 |
STELKAST PROVEN KNEE SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
| K002118 |
08/09/2000 |
STOCKERT COMPACT SYSTEM VERSION 2.0 |
STOECKERT INSTRUMENTE |
CYNTHIA J. M. NOLTE |
| K993166 |
08/04/2000 |
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM |
Stryker Endoscopy |
TODD MILLER |
| K002324 |
08/24/2000 |
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA |
SULZER MEDICA |
FRANCES E HARRISON |
| K002018 |
08/17/2000 |
NDO SURGICAL SURGICAL OVERTUBE |
SURGICAL, INC. |
JEFF CERIER |
| K001881 |
08/22/2000 |
IMPROVED ENLIGHT LV |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K001899 |
08/28/2000 |
IMPROVED TRY-IN GEL |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K002271 |
08/25/2000 |
2.4MM CORTEX SCREW, SELF-TAPPING |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K001720 |
08/24/2000 |
SYNTHES SACRAL BAR SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K001793 |
08/17/2000 |
SYNTHES SCALLOPED DISTAL TIBIA PLATE |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K001683 |
08/21/2000 |
SYSMEX R-500 |
SYSMEX CORPORATION OF AMERICA |
NINA GAMPERLING |
| K990100 |
08/02/2000 |
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE |
TE ME NA S.A.R.L. |
JOE HARMS |
| K002404 |
08/30/2000 |
MICRO-MAX, MODEL 319 |
TEK MARKETING, INC. |
JOHN A HOPE |
| K002238 |
08/22/2000 |
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K001572 |
08/14/2000 |
NEOLUS NEEDLE |
TERUMO EUROPE N.V. |
M J AERTS |
| K001978 |
08/08/2000 |
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
| K001127 |
08/30/2000 |
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K001636 |
08/24/2000 |
C-REACTIVE PROTEIN ANTISERUM KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K001556 |
08/21/2000 |
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K001712 |
08/31/2000 |
3D ACTIVETRAC |
THE SAUNDERS GROUP |
DOUGLAS G TOMASKO |
| K994198 |
08/25/2000 |
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L |
TORAY INDUSTRIES (AMERICA), INC. |
LISA S JONES |
| K994041 |
08/31/2000 |
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS |
TORNIER, INC. |
DAVID W SCHLERF |
| K001818 |
08/30/2000 |
UTERINE TENACLUM HOOK |
TOWNE BROTHERS (PVT.), LTD. |
ABDUL GHAFOOR |
| K002258 |
08/08/2000 |
ULTRAGUIDE CT-GUIDE 1010 |
ULTRAGUIDE LTD. |
GEORGE MYERS |
| K002008 |
08/16/2000 |
SURGICAL DYNAMICS SPINAL RETRACTOR |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER E SCHUCK |
| K001590 |
08/02/2000 |
DND 101 |
UROGYN LTD. |
KENNETH T BURCK |
| K001870 |
08/14/2000 |
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL |
USA INSTRUMENTS, INC. |
TORI BRUNS |
| K002276 |
08/29/2000 |
PSI SKULL CLAMP |
V. MUELLER NEURO/SPINE |
GARY COOPER |
| K000401 |
08/24/2000 |
VAPOTHERM, MODEL 2000I |
VAPOTHERM, INC. |
WILLIAM NILAND |
| K002312 |
08/30/2000 |
PROTON VISION 7.0 |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K002194 |
08/18/2000 |
TREATVISION |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K001633 |
08/24/2000 |
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 |
VASCA, INC. |
DOUGLAS E FERGUSON |
| K001938 |
08/29/2000 |
VECTOR TARGETING SYSTEM |
VECTOR MEDICAL, INC. |
ERIN MCGURK |
| K000796 |
08/11/2000 |
MAGIC MOBILITY 4 X 4 WHEELCHAIR |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
| K001553 |
08/03/2000 |
BREAS PV 100 CPAP SYSTEM |
VITAL SIGNS, INC. |
ANTHONY P MARTINO |
| K993934 |
08/15/2000 |
V QUICK PATCH |
VQ CORP. |
MICHAEL A PRICE |
| K993052 |
08/03/2000 |
VYGON 2 FR EPICUTANEO PUR-CATHETER |
VYGON CORP. |
ROBERT SCHIFF |
| K993442 |
08/03/2000 |
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) |
VYGON CORP. |
ROBERT SCHIFF |
| K000356 |
08/25/2000 |
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K000354 |
08/25/2000 |
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K001878 |
08/03/2000 |
WATER PURIFIER |
WATERCLAVE, L.L.C. |
M. JOSEPH OLK |
| K000574 |
08/09/2000 |
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) |
WR MEDICAL ELECTRONICS CO. |
PATRICK J ANDERSON |
| K002149 |
08/31/2000 |
LINEAGE ACETABULAR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K001706 |
08/16/2000 |
WMT MODULAR SHOULDER SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K000737 |
08/01/2000 |
COAXIAL DILATOR SET |
XENTEK MEDICAL, INC. |
JIM EDDINGS |
