FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K981325 |
04/13/1998 |
3M M.G. MATERIAL |
3M COMPANY |
AMY E FOWLER |
K981342 |
04/13/1998 |
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY |
ABBOTT LABORATORIES |
JANICE E BROWN |
K981468 |
04/23/1998 |
ALBG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981245 |
04/06/1998 |
ALKALINE PHOSPHATASE (ALKP) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981467 |
04/23/1998 |
AMM |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981216 |
04/03/1998 |
AMY |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981225 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE (AST) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981221 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981476 |
04/24/1998 |
CHOL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981218 |
04/03/1998 |
CREATINE KINASE (CK) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981240 |
04/06/1998 |
CREATININE (CREA) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981222 |
04/03/1998 |
DIRECT BILIRUBIN (DBIL) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981224 |
04/03/1998 |
DIRECT HDL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981303 |
04/10/1998 |
DIRECT LDL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981185 |
04/02/1998 |
GLU |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981241 |
04/06/1998 |
IRON |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981338 |
04/13/1998 |
LD-1 |
ABBOTT LABORATORIES |
MIKE LITTLEFIELD |
K981192 |
04/02/1998 |
MG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981336 |
04/13/1998 |
TBIL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981279 |
04/08/1998 |
TIBC |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981295 |
04/09/1998 |
UPRO |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981189 |
04/02/1998 |
URIC ACID |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981457 |
04/23/1998 |
ALBP |
ABBOTT MFG., INC. |
MARK LITTLEFIELD |
K981232 |
04/03/1998 |
CA |
ABBOTT MFG., INC. |
MARK LITTLEFIELD |
K981231 |
04/03/1998 |
CO2 |
ABBOTT MFG., INC. |
MARK LITLEFIELD |
K981526 |
04/28/1998 |
ACE ALVEOLAR DISTRACTOR |
ACE SURGICAL SUPPLY CO., INC. |
EDWARD J CARCHIDI |
K981227 |
04/03/1998 |
SYMPHONY 360 REMOTE CONTROL TABLE |
ACOMA MEDICAL IMAGING, INC. |
JIM LAMBRECHT |
K981274 |
04/08/1998 |
ACROMED TIMX PLATE BASED LOW BACK SYSTEM |
ACROMED CORP. |
MARY LEWIS |
K981181 |
04/01/1998 |
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) |
ACTIMED LABORATORIES, INC. |
SUSAN MCGEEHAN |
K981291 |
04/09/1998 |
VANTAGE 3.0 INSYNCH |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
K981252 |
04/06/1998 |
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) |
ALDEN OPTICAL LABS., INC. |
MARTIN DALSING |
K981168 |
04/01/1998 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
ALLERGAN, INC. |
PAUL J NOWACKI |
K981396 |
04/17/1998 |
PYLORIPROBE |
AMDL, INC. |
THAT T NGO |
K981533 |
04/29/1998 |
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 |
AMERICAN TELECARE, INC. |
GERARD J PRUD'HOMME |
K981504 |
04/27/1998 |
DBEST AMPHETAMINES TEST KIT |
AMERITEK, INC. |
K.C. YEE |
K981392 |
04/17/1998 |
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE |
ANSELL PERRY |
JAMES R CHATTERTON |
K981299 |
04/09/1998 |
SILVERLON CONTACT WOUND DRESSING |
ARGENTUM INTERNATIONAL LLC. |
A BART FLICK |
K981286 |
04/08/1998 |
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS |
ARMM, INC. |
ROGER WOOD |
K981187 |
04/02/1998 |
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 |
ARTHREX, INC. |
SCOTT M DURLACHER |
K981220 |
04/03/1998 |
SYSTEM 7500 ABC ELECTROSURGICAL UNIT |
ASPEN LABORATORIES, INC. |
CHARLES (MIKE) M HART |
K981423 |
04/20/1998 |
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 |
AUTOGENESIS, INC. |
JAMES EDWARDS |
K981294 |
04/09/1998 |
ODYSSEY INSTRUMENTATION SYSTEM |
AUTOMATA INSTRUMENTATION, INC. |
LINDA V MASANO |
K981353 |
04/14/1998 |
AVOGEL |
AVOCET POLYMER TECHNOLOGIES, INC. |
MARY CAPELLI-SCHELLPFEFFER |
K981318 |
04/10/1998 |
DUAL LUER LOCK CAP |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
K981312 |
04/10/1998 |
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
K981280 |
04/08/1998 |
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS |
BAYER CORP., AGFA DIV. |
MICHAEL SULLIVAN |
K981354 |
04/14/1998 |
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 |
BECKMAN INSTRUMENTS, INC. |
ELLEN M VOSS |
K981403 |
04/17/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
K981517 |
04/28/1998 |
CEFDINIR, 5 UG, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
K981439 |
04/21/1998 |
CCA-200 |
BENSON MEDICAL INSTRUMENTS CO. |
DAVID P MAYOU |
K981184 |
04/01/1998 |
SHARPTRACK REUSABLE SHARPS CONTAINER |
BFI- MEDICAL WASTE SYSTEMS |
A W SIEGNER |
K981532 |
04/29/1998 |
LYPHOCHEK IMMUNOASSAY PLUS CONTROL |
BIO-RAD |
ELIZABETH PLATT |
K981230 |
04/03/1998 |
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODGEMAN |
K981459 |
04/23/1998 |
MEMBRANE TACK |
BIOMET, INC. |
MARY VERSTYNEN |
K981333 |
04/13/1998 |
NITRILON CORRECT-TOUCH |
BIOPRO (M) SDN BHD |
MIKE KYLE |
K981293 |
04/09/1998 |
7200 ULTRASOUND IMAGING SYSTEM |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
K981358 |
04/14/1998 |
ARTOSCAN S |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
K981243 |
04/06/1998 |
BIOSTRIDE FREE T4 EIA TEST KIT |
BIOSTRIDE DIAGNOSTICS, INC. |
JANIS FREESTONE |
K981401 |
04/17/1998 |
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
K981413 |
04/20/1998 |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
BOSTON SCIENTIFIC SCIMED, INC. |
MARIA BRITTLE |
K981445 |
04/22/1998 |
ULTIMA AIRFLOW SENSOR, 0510 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
K981394 |
04/17/1998 |
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 |
BRAEMAR CORP. |
DAVID NORBERG |
K981508 |
04/27/1998 |
VECTORVISION SPINE MODULE |
BRAINLAB, AG |
STEFAN VILSMEIER |
K981172 |
04/01/1998 |
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES |
BYRON MEDICAL |
STEVE BOLLINGER |
K981215 |
04/02/1998 |
PSI-TEC LIPOSUCTION ASPIRATOR |
BYRON MEDICAL |
STEVE BOLLINGER |
K981351 |
04/14/1998 |
CANDELA GENTLELASE GL DERMATOLOGICAL LASER |
CANDELA CORP. |
JAY CAPLAN |
K981206 |
04/01/1998 |
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) |
CARDIOVASCULAR DIAGNOSTICS, INC. |
GREG GODLEVSKI |
K981178 |
04/01/1998 |
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
CYNTHIA PRITCHARD |
K981610 |
04/30/1998 |
CARESIDE ANALYZER |
CARESIDE, INC. |
KENNETH B ASARCH |
K981604 |
04/28/1998 |
CARESIDE URIC ACID |
CARESIDE, INC. |
KENNETH B ASARCH |
K981436 |
04/14/1998 |
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 |
CASCO STANDARDS |
CHRISTINE V BEACH |
K981368 |
04/15/1998 |
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
K981382 |
04/16/1998 |
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
K981182 |
04/01/1998 |
OSTEOGRAF/N-300 |
CERAMED DENTAL, LLC. |
MARK BOWERMAN |
K981214 |
04/02/1998 |
OSTEOGRAF/N-700 |
CERAMED DENTAL, LLC. |
MARK BOWERMAN |
K981415 |
04/20/1998 |
0-20 CM H20 PEEP VALVE |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
K981478 |
04/24/1998 |
ACS:CENTAUR CEA |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
K981284 |
04/08/1998 |
BETTER-BLADDER (BB) |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
K981412 |
04/20/1998 |
M1145 (UPS1-1.25K-1G-MP) UPS |
CLARY CORP. |
SUSAN D GOLDSTEIN-FALK |
K981260 |
04/06/1998 |
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M |
CLINICAL INNOVATIONS, INC. |
WM D WALLACE |
K981535 |
04/29/1998 |
FOCUS PILOT CONTOURING WORKSTATION |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
K981339 |
04/13/1998 |
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
K981407 |
04/20/1998 |
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER |
CORDIS CORP. |
MIRJAM BARBOZA |
K981202 |
04/02/1998 |
WATER FILLED GUM SOOTHER |
CORIUM CORP. |
JOSEPH HAKIM |
K981276 |
04/08/1998 |
N-ASSAY L D-BIL |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
K981289 |
04/08/1998 |
N-ASSAY L T-BIL |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
K981428 |
04/20/1998 |
ANU ICE |
CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. |
JORGE CABALLERO |
K981304 |
04/10/1998 |
NITRILON CORRECT-TOUCH |
CT INTL. |
MIKE KYLE |
K981469 |
04/23/1998 |
CERMAX300 LIGHTSOURCE |
CUDA PRODUCTS CO. |
KIM REED |
K981711 |
04/27/1998 |
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K981199 |
04/02/1998 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
K981378 |
04/16/1998 |
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
K981320 |
04/10/1998 |
DAUM BONE BIOPSY SET |
DAUM CORP. |
GARY J SFEIR, RAC |
K981487 |
04/27/1998 |
DEPUY GLOBAL SHOULDER GLENOID |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
K981239 |
04/03/1998 |
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
DEROYAL SURGICAL |
CAMILLE MATLOCK |
K981167 |
04/01/1998 |
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT |
DHD HEALTHCARE CORP. |
JEAN WALLACE |
K981495 |
04/27/1998 |
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K981297 |
04/08/1998 |
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K981455 |
04/23/1998 |
THIRD GENERATION PSA CONTROL MODULE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K981306 |
04/10/1998 |
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K981498 |
04/27/1998 |
IS-TOXOPLASMA IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K981270 |
04/07/1998 |
IRMA BLOOD ANALYSIS SYSTEM |
DIAMETRICS MEDICAL, INC. |
STEVE BOEH |
K981485 |
04/24/1998 |
HYBRID CAPTURE II GC-ID |
DIGENE CORP. |
MARK A DEL VECCHIO |
K981438 |
04/21/1998 |
DORNIER MEDILAS E |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERENCKE |
K981472 |
04/24/1998 |
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
DRAEGER MEDICAL, INC. |
J. TERESA DORRIETY |
K981267 |
04/07/1998 |
FACTS MONOBLOCK |
DYNARAD CORP. |
RAYMOND MANEZ |
K981272 |
04/07/1998 |
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES |
ELECTRO THERAPEUTIC DEVICES, INC. |
K C CHOONG |
K981483 |
04/24/1998 |
EBI DFS JOINT FIXATOR, MODEL 02800 |
ELECTRO-BIOLOGY, INC. |
JON CAPAROTTA |
K981219 |
04/03/1998 |
OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES |
ENABLE MEDICAL CORP. |
MARK L FRIEDMAN, PHD |
K981329 |
04/13/1998 |
FETH-R-KATH |
EPIMED INTERNATIONAL, INC. |
DONALD HENDERSON |
K981343 |
04/13/1998 |
ERCO-RIBBON |
ERCONS, INC. |
YAKOV ALTSHULER |
K981357 |
04/14/1998 |
ERCO-VAC |
ERCONS, INC. |
YAKOV ALTSHULER |
K981361 |
04/14/1998 |
POWERSTAR BIPOLAR SCISSORS |
ETHICON, INC. |
GREGORY R JONES |
K981708 |
04/27/1998 |
DENTAL PORCELAIN-VARIOUS |
EXCEL PORCELAIN PRODUCTS |
ANDREW J PIETROBONO |
K981183 |
04/01/1998 |
CARESIDE GLUCOSE |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
K981548 |
04/30/1998 |
NFC NEEDLEFREE CONNECTOR MODEL 69900 |
FILTERTEK, INC. |
LARRY LARKIN |
K981547 |
04/30/1998 |
NFC NEEDLEFREE Y-SITE, MODEL 69970 |
FILTERTEK, INC. |
LARRY LARKIN |
K981414 |
04/20/1998 |
LC POSITIONER |
FISCHER IMAGING CORP. |
SAMUEL D EMRICH |
K981541 |
04/29/1998 |
CLEARSTAR ENTERAL NUTRITION PUMP |
FRANTZ MEDICAL DEVELOPMENT, LTD. |
J P HANSON |
K981404 |
04/17/1998 |
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
K981301 |
04/09/1998 |
SPEED-CUT AUTOMATIC BIOPSY SYSTEM |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
K981486 |
04/24/1998 |
STAIR-LIFT |
GARAVENTA (CANADA) LTD. |
ALYSSA CHUMNANVECH |
K981514 |
04/28/1998 |
GC FUJI BOND LC |
GC AMERICA, INC. |
TERRY L JORITZ |
K981461 |
04/23/1998 |
GC FUJI ORTHO LC |
GC AMERICA, INC. |
TERRY L JORITZ |
K981370 |
04/15/1998 |
MIRACLE MIX CAPSULE |
GC AMERICA, INC. |
TERRY L JORITZ |
K981190 |
04/02/1998 |
HIGH IMPEDANCE CARDIAC GATING CABLE |
GE MEDICAL SYSTEMS |
LARRY KROGER |
K981217 |
04/03/1998 |
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS |
LARRY KROGER |
K981352 |
04/14/1998 |
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 |
GE MEDICAL SYSTEMS F.I. HAIFA |
YAIR FRIEDMAN |
K981296 |
04/09/1998 |
GEEN MEDISOX |
GEEN HEALTHCARE, INC. |
GREG W GEEN |
K981322 |
04/10/1998 |
CUTALON NYLON POLYAMIDE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
JIM KENNEY |
K981422 |
04/20/1998 |
TC SERIES |
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. |
EUGENE M NAVES |
K981421 |
04/20/1998 |
TC SERIES (RECLINER) |
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. |
EUGENE M NAVES |
K981419 |
04/20/1998 |
TC SERIES (TILT RECLINER) |
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. |
EUGENE M NAVES |
K981418 |
04/20/1998 |
TC SERIES (TRANSPORT) |
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. |
EUGENE M NAVES |
K981420 |
04/20/1998 |
TC SERIES (WIDE) |
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. |
EUGENE M NAVES |
K981360 |
04/14/1998 |
VINYL PATIENT EXAMINATION GLOVE, POWDERED |
GLORMED INTL., INC. |
JANNA TUCKER |
K981432 |
04/20/1998 |
GOLDMAN MANUAL TONOMETER |
GOLDEN VISION, INC. |
ANDRES R QUIROZ |
K981524 |
04/28/1998 |
PRILANE |
GRESCO PRODUCTS, INC. |
CLINTON D VAUPEL |
K981381 |
04/16/1998 |
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 |
GUIDANT CORP. |
MARGARET ANDERSON |
K981536 |
04/29/1998 |
QUANTECH MYOGLOBIN ASSAY |
HELLEN PROFESSIONAL SERVICES |
ROBIN J HELLEN |
K981546 |
04/30/1998 |
NTI CLENCHING SUPPRESSION SYSTEM |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K981376 |
04/16/1998 |
HEWLETT-PACKARD M1205A VIRIDIA 24 CT |
HEWLETT-PACKARD CO. |
DAVID OSBORN |
K981265 |
04/07/1998 |
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA |
HEWLETT-PACKARD CO. |
RENEE J THIBEAULT |
K981434 |
04/21/1998 |
EUP-OL334 LAPARASCOPICPROBE |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER |
K981261 |
04/07/1998 |
HOWMEDICA SCN NAIL |
HOWMEDICA CORP. |
VIVIAN KELLY |
K981201 |
04/02/1998 |
OSTEOLOCK ACETABULAR CUP |
HOWMEDICA CORP. |
FRANK MAAS |
K981283 |
04/08/1998 |
ROGACHEFSKY DISTAL RADIUS PLATES |
HOWMEDICA, INC. |
JOHN DICHIRA |
K981327 |
04/13/1998 |
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
DONNA WARD |
K981466 |
04/23/1998 |
XR-910 |
IMAGING SCIENCES INTL., INC. |
ROBERT E HAY |
K981313 |
04/10/1998 |
SEQUENCER |
IMPAC MEDICAL SYSTEMS, INC. |
JAMES HOEY |
K981193 |
04/02/1998 |
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN M PAGE |
K981340 |
04/13/1998 |
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
K981330 |
04/13/1998 |
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K981328 |
04/13/1998 |
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K981237 |
04/03/1998 |
QUANTA LITE RIBOSOME P ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K981249 |
04/06/1998 |
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
K981200 |
04/02/1998 |
IL TEST PLASMINOGEN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K981479 |
04/24/1998 |
IL TEST PT-FIBRINOGEN RECOMBINANT |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K981263 |
04/07/1998 |
TOXOGEN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K981534 |
04/29/1998 |
VIPERCAM |
INTEGRA MEDICAL |
W. EDWARD JOHANSEN |
K981246 |
04/06/1998 |
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) |
INTEGRA NEUROCARE LLC. |
LORI HAYS |
K981308 |
04/10/1998 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
E.J. Smith |
K981307 |
04/10/1998 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
E.J. Smith |
K981398 |
04/17/1998 |
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM |
INTERNEURON PHARMACEUTICALS, INC. |
SONJA LOAR |
K981253 |
04/06/1998 |
ULTRACON ULTRAFILTRATOR |
INTERPORE INTL. |
LYNN M RODARTI |
K981191 |
04/02/1998 |
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
K981335 |
04/13/1998 |
ARISTON PHC LINER |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
K981264 |
04/07/1998 |
ARISTON PHC |
IVOCLAR USA, INC. |
PETER P MANCUSO |
K981244 |
04/06/1998 |
BW-1 (CODE NAME RD-0807) |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
K981257 |
04/06/1998 |
JELFINE-52 (CODE NAME RD-0901) |
J.F. JELENKO & CO., INC. |
TRIBID DASGUPTA |
K981247 |
04/06/1998 |
SILCAST (CODE NAME RD-0118) |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
K981490 |
04/27/1998 |
WILLI GELLER CREATION PORCELAIN |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
K981456 |
04/23/1998 |
BABY PACIFIER DIGITAL THERMOMETER |
K-JUMP HEALTH CO., LTD. |
ROBERT J ZAPPA |
K981458 |
04/23/1998 |
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
K981233 |
04/03/1998 |
KSEA CALCUSPLIT |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
K981311 |
04/10/1998 |
COWBOY XV |
KCI NEW TECHNOLOGIES, INC. |
JUDITH HARBOUR |
K981393 |
04/17/1998 |
MICROCOOL SURGICAL GOWN |
KIMBERLY-CLARK CORP. |
LARRY R KLUDT |
K981251 |
04/06/1998 |
KYPHON INFLATABLE BONE TAMP |
KYPHON, INC. |
KAREN TALMADGE |
K981549 |
04/30/1998 |
LACTATION TECHNIQUES MODEL B |
LACTATION TECHNIQUES, INC. |
MARK LELOUDIS |
K981326 |
04/13/1998 |
LAKE REGION MANUFACTURING GUIDEWIRES |
LAKE REGION MFG., INC. |
KIM E AVES |
K981235 |
04/03/1998 |
OCULOSTAT |
LASER CENTER DEV. CORP. |
FRANCIS E O'DONNELL |
K981345 |
04/14/1998 |
CHOLESTRON PRO II CHOLESTEROL TEST |
LIFESTREAM DIAGNOSTICS, INC. |
Erika B Ammirati |
K981269 |
04/07/1998 |
UNIVERSAL DRIVE SYSTEM |
LINVATEC CORP. |
CAROL A WEDEMAN |
K981234 |
04/04/1998 |
FLARE,FILE, FILL |
LONE STAR TECHNOLOGIES |
EDWARD SPEHAR |
K981179 |
04/01/1998 |
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES |
LOVYTEX SDN BHD |
M.G. DESAI |
K981531 |
04/29/1998 |
SUTURE PLACEMENT DEVICE AND ACCESSORIES |
LSI SOLUTIONS |
JUDE S SAUER |
K981951 |
04/29/1998 |
CT 100 ELECTROCARDIOGRAPH |
MACQUARIE MEDICAL SYSTEMS |
FRANK FERGUSON |
K981310 |
04/10/1998 |
MAGNATEK C-300 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
K981416 |
04/20/1998 |
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
K981386 |
04/16/1998 |
MANAN BLUNT NEEDLE |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
K981477 |
04/24/1998 |
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE |
MEDICAL BIOPSY, INC. |
STEPHEN M PAGE |
K981258 |
04/06/1998 |
MANAN MALECOT BASKET DRAINAGE CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K981229 |
04/03/1998 |
MANAN MANTA CATHETER FIXATION DISK |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K981509 |
04/28/1998 |
TEMPO III |
MEDICAL PRODUCTS, INC. |
DURWARD FARIES, JR. |
K981387 |
04/16/1998 |
EVANESCE SCAR MANAGEMENT SYSTEM |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA |
K981510 |
04/28/1998 |
SONOACE 6000/ ULTRAMARK 400 |
MEDISON AMERICA, INC. |
|
K981511 |
04/28/1998 |
OTO WIZZARD |
MEDRX, INC. |
JEFFREY A MCLAUGHLIN |
K981198 |
04/02/1998 |
MEDTRONIC ZUMA GUIDING CATHETER |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARK CHARTIER |
K981527 |
04/28/1998 |
MENTOR PATHWAY INTRODUCER/DILATOR |
MENTOR CORP. |
DONNA A CRAWFORD |
K981417 |
04/20/1998 |
SQUIRT MODEL NUMBER FDS100 |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS D REIGLE |
K981337 |
04/13/1998 |
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K981373 |
04/16/1998 |
ALKPHASE-B ASSAY KIT |
METRA BIOSYSTEMS, INC. |
JILL VISOR |
K981364 |
04/15/1998 |
PYRILINKS-D ASSAY KIT |
METRA BIOSYSTEMS, INC. |
JILL VISOR |
K981388 |
04/16/1998 |
MICRO-STRIP FOR COCAINE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
K981389 |
04/16/1998 |
DISPOSABLE RE-NEW FORCEPS |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
K981188 |
04/02/1998 |
ELECTROSURGICAL CAUTERY PROBES |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
K981433 |
04/20/1998 |
ORTHODONTIC BRACES |
MIDWEST ORTHODONTIC MFG. |
JEFFREY L FASNACHT |
K981266 |
04/07/1998 |
AUTO-INJECTOR, SURE-INJECT 2000 |
MIGHTY MO, CORP. |
JOHN D'ANGELO |
K981460 |
04/23/1998 |
CUB DIS II DPOAE MEASUREMENT SYSTEM |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
K981250 |
04/06/1998 |
LICEMEISTER COMB |
NATIONAL PEDICULOSIS ASSOC. |
HANS SCHWARTZ |
K981194 |
04/02/1998 |
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
JAMAL D RUSHY |
K981447 |
04/22/1998 |
DIO-LIGHT 60 LASER SYSTEM |
NIDEK, INC. |
KEN KATO |
K981424 |
04/20/1998 |
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM |
NOMOS CORP. |
MARVIN L SUSSMAN |
K981427 |
04/16/1998 |
STAT PROFILE M ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K981425 |
04/16/1998 |
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K981426 |
04/16/1998 |
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K981323 |
04/13/1998 |
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE |
NOVARTIS NUTRITION CORP. |
ROBERT J LANG |
K981488 |
04/27/1998 |
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION |
OAK CAROLINA, INC. |
DARRELL W ALFORD |
K981305 |
04/10/1998 |
OLYMPUS SERUM PROTEIN MULTICALIBRATOR |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K981464 |
04/23/1998 |
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
K981463 |
04/23/1998 |
OMNITECH RESECTOSCOPE ROLLER ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
K981341 |
04/13/1998 |
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) |
ORASURE TECHNOLOGIES, INC. |
R S NIEDBALA |
K981315 |
04/10/1998 |
NAVITRACK |
ORTHOSOFT, INC. |
NICOLE LANDREVILLE |
K981259 |
04/06/1998 |
OSTEO 4.0MM CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTTON |
K981309 |
04/10/1998 |
OSTEO I-C HUMERAL NAIL SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
K981452 |
04/22/1998 |
OSTEONICS LONG ARM CONTAINMENT RING |
OSTEONICS CORP. |
KATE SUTTON |
K981405 |
04/20/1998 |
SYNERGY LT |
OXFORD INSTRUMENTS, PLC. |
JEFF HALL |
K981431 |
04/20/1998 |
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 |
PANASONIC CORPORATION (PANASONIC) |
EDWARD M BASILE, ESQ. |
K981542 |
04/29/1998 |
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 |
PANASONIC CORPORATION (PANASONIC) |
EDWARD M BASILE |
K981390 |
04/16/1998 |
ODONTOSURGE 2 |
PERIOGIENE |
DAVID L WEST |
K981406 |
04/20/1998 |
CERVIX COIL LATEX SHEATH |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
K981410 |
04/20/1998 |
HAMMERSMITH ENDOCAVITARY COILS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KELLER |
K981480 |
04/24/1998 |
PHILIPS EASYGUIDE |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
K981493 |
04/27/1998 |
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K981374 |
04/16/1998 |
POREX NOSTRIL RETAINERS |
POREX SURGICAL, INC. |
HOWARD A MERCER |
K981180 |
04/01/1998 |
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT |
POS-T-VAC, INC. |
MARK A HELLER |
K981173 |
04/01/1998 |
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) |
PRECISION BIOLOGICALS, INC. |
SANDY MORRISON |
K981174 |
04/01/1998 |
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) |
PRECISION BIOLOGICALS, INC. |
SANDY MORRISON |
K981379 |
04/16/1998 |
AURORA |
PREMIER LASER SYSTEMS, INC. |
BETH A SOPER |
K981443 |
04/22/1998 |
BIOSIGN HCG I - ONE STEP PREGNANCY TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K981444 |
04/22/1998 |
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K981371 |
04/16/1998 |
LTV 1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
DOUGLAS DEVRIES |
K981213 |
04/02/1998 |
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I |
RADIONICS, INC. |
LISA M BENATI |
K981208 |
04/02/1998 |
TFR |
RAMCO LABORATORIES, INC. |
JEFFREY B GRUBB |
K981391 |
04/17/1998 |
PAR-ONE |
REMEL, INC. |
MARY ANN SILVIUS |
K981506 |
04/27/1998 |
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) |
REPRO-MED SYSTEMS, INC. |
ANDREW I SEALFON |
K981321 |
04/10/1998 |
BIPOLAR FORCEPS SET (MODULAR) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K981334 |
04/13/1998 |
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K981282 |
04/08/1998 |
ELECSYS AFP |
ROCHE DIAGNOSTICS GMBH |
Patricia M Klimley |
K981278 |
04/08/1998 |
ELECSYS CALCHECK CA 125II |
ROCHE DIAGNOSTICS GMBH |
Patricia M Klimley |
K981281 |
04/08/1998 |
ELECSYS CALCHECK FERRITIN |
ROCHE DIAGNOSTICS GMBH |
PATRICIA M KLIMELY |
K981203 |
04/02/1998 |
RUSCH BLAKEMORE 3 LUMEN, STERILE |
RUSCH INTL. |
JAMES R WHITNEY |
K981375 |
04/16/1998 |
ACE T UPTAKE REAGENT TU CALIBRATORS |
SCHIAPPARELLI BIOSYSTEMS, INC. |
STEVEN DALESSIO |
K981377 |
04/16/1998 |
ACE T4 REAGENT T4 CALIBRATORS |
SCHIAPPARELLI BIOSYSTEMS, INC. |
STEVEN DALESSIO |
K982009 |
04/02/1998 |
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE |
SCITECH SOLUTIONS, INC. |
CLIVE M DEFTY |
K981366 |
04/15/1998 |
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES |
SENSORMEDICS CORP. |
LARRY MURDOCK |
K981496 |
04/27/1998 |
COLOR-SLIDE RF |
SERADYN, INC. |
MARTIN J WEINSTEIN |
K981430 |
04/20/1998 |
UNION MEDICAL UM-D30 COAGULATOR |
SHE MEDICAL, INC. |
ANNIE VELEZ |
K981365 |
04/15/1998 |
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS |
SHERWOOD MEDICAL CO. |
ROSEMARY HARRY |
K981528 |
04/29/1998 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE C HESLER |
K981248 |
04/06/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K981254 |
04/06/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K981255 |
04/06/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K981302 |
04/09/1998 |
SMC 28MM CERAMIC FEMORAL HEADS |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN, JR. |
K981512 |
04/28/1998 |
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 |
SKD, INC. A BECKMAN COULTER CO. |
KAREN RICHARDS |
K981449 |
04/22/1998 |
SD-956 ULTRASOUND THERAPY |
SKYLARK DEVICE CO., LTD. |
GEORGE K C CHEN |
K981349 |
04/10/1998 |
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K981347 |
04/10/1998 |
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K981348 |
04/10/1998 |
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K981529 |
04/29/1998 |
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW |
SMITH & NEPHEW, INC. |
JOANN KUHNE |
K981505 |
04/24/1998 |
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSITE,INC. |
|
K981383 |
04/16/1998 |
ALLOYBOND |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
K981530 |
04/29/1998 |
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM |
SPACELABS MEDICAL, INC. |
RUSS GARRISON |
K981474 |
04/24/1998 |
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) |
SPECTRAL DIAGNOSTICS, INC. |
JOSEPH LAURINO |
K981451 |
04/22/1998 |
ARGOMEDICAL BIPOLAR SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
K981497 |
04/27/1998 |
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
K981516 |
04/28/1998 |
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB |
STERNGOLD/IMPLAMED |
KAREN HICKEY |
K981211 |
04/02/1998 |
APR -T REVISION HIP STEM |
SULZER ORTHOPEDICS, INC. |
SHAVAWN E PARDUHN |
K981314 |
04/10/1998 |
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K981462 |
04/23/1998 |
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
K981346 |
04/14/1998 |
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
K981448 |
04/22/1998 |
KERR HARD DENTURE RELINE MATERIAL |
SYBRON DENTAL SPECIALTIES, INC. |
WENDY A URTEL |
K981362 |
04/15/1998 |
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K981275 |
04/08/1998 |
SYNTHES (USA) RATCHETING DISTRACTOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K981372 |
04/16/1998 |
SYNTHES 3.0 MM PC-FIX SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K981292 |
04/09/1998 |
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
K981197 |
04/02/1998 |
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST |
TCPI, INC. |
JACK L ARONOWITZ . |
K981363 |
04/15/1998 |
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST |
TCPI, INC. |
JEFFREY BOLTS |
K981359 |
04/14/1998 |
GT LEGGIERO |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
K981209 |
04/02/1998 |
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
K981543 |
04/30/1998 |
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
K981171 |
04/01/1998 |
ERADIC-ALL |
THERATECHNOLOGIES, INC. |
ANDRE DE VILLERS |
K981397 |
04/17/1998 |
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K981475 |
04/24/1998 |
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE |
TOSHIBA AMERICA MRI, INC. |
BRUCE E CLARK |
K981522 |
04/28/1998 |
AIA-PACK TGAB ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
K981521 |
04/28/1998 |
AIA-PACK TPOAB ASSAY |
TOSOH MEDICS, INC. |
LON ROBINSON |
K981441 |
04/21/1998 |
HEART CATH TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
K981207 |
04/02/1998 |
CLEARPLAN EASY FERTILITY MONITOR |
UNIPATH LTD. |
Louise Roberts |
K981271 |
04/07/1998 |
CLEARPLAN EASY OVULATION TEST |
UNIPATH LTD. |
Louise Roberts |
K981344 |
04/09/1998 |
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING |
URESIL CORP. |
LEV MELINYSHYN |
K981491 |
04/27/1998 |
UROSURGE FILASTENT URETERAL STENT |
UROSURGE, INC. |
THOMAS BECZE |
K981489 |
04/27/1998 |
UROSURGE SPIRASTENT PLUS URETERAL STENT |
UROSURGE, INC. |
THOMAS BECZE |
K981262 |
04/07/1998 |
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
VALLEYLAB, INC. |
JULIE ROSS |
K981277 |
04/08/1998 |
PERIFORM |
VERIMED HOLDINGS, INC. |
KISHORE PUPPALA |
K981446 |
04/22/1998 |
WAKO AUTOKIT LP(A) |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K981238 |
04/03/1998 |
BIPOLAR FEMORAL HEAD |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
K981470 |
04/23/1998 |
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY A LAMOUREUX |
K981256 |
04/02/1998 |
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
K981350 |
04/14/1998 |
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |