FDA 510(k) Applications Received During April, 1998

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


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