FDA 510(k) Decisions During October, 1999  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K992326 10/08/1999 3M CLINPRO SEALANT 3M COMPANY LAEL J PICKETT
K993211 10/25/1999 PICCOLO SODIUM TEST SYSTEM ABAXIS, INC. LISA MCGRATH
K992858 10/25/1999 ABBOTT AXSYM HOMOCYSTEINE ABBOTT LABORATORIES MARGARET PROCHNIAK
K993083 10/05/1999 ALCYON 300I (WITH ISE MODULE) ANALYZER ABBOTT LABORATORIES MARK LITTLEFIELD
K992511 10/15/1999 ABX PENTRA 60 HEMATOLOGY ANALYZER ABX DIAGNOSTICS PAT AMTOWER
K992421 10/27/1999 GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 ACCUTRON, INC. DOTTIE KNECHTEL
K993065 10/08/1999 ACON COMBO PREGNANCY ACON LABORATORIES, INC. JIXUN LIN
K992580 10/18/1999 FETAL ASSESSMENT CAP ACUSON CORP. WILLIAM E WELCH
K992317 10/01/1999 AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION ADAC LABORATORIES DENNIS W HENKELMAN
K992169 10/28/1999 ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE ADVANCED CARDIOVASCULAR SYSTEMS, INC. MARGARET ANDERSON
K992551 10/27/1999 ALPHA INFUSION PUMP ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K991487 10/08/1999 CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS JOHN E FRIND
K992707 10/19/1999 MCL 29 DERMABLATE ER:YAG LASER SYSTEM AESCULAP-MEDITEC NORTH AMERICA WILLIAM KELLEY
K993245 10/28/1999 CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM ALBA CRITICAL CARE LTD TED VANDER WIEDE
K991709 10/08/1999 BROWNE CIDEX OPA INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K991205 10/13/1999 ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K992028 10/07/1999 REFRESH CONTACTS LUBRICATING AND REWETTING DROPS ALLERGAN, INC. PAUL J NOWACKI
K992870 10/15/1999 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K992902 10/25/1999 AMBU HAND POWER SUCTION PUMP AMBU, INC. SANJAY PARIKH
K992452 10/18/1999 RAPIDONE-AMPHETAMINE TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K992619 10/25/1999 AMIGO MODEL 680000 (AMIGO EXCITE F 350) AMIGO MOBILITY INTL., INC. DALE CONFER
K992447 10/20/1999 50 W METAL HALIDE ILLUMINATOR, VES 0501. ANGIOLAZ, INC. JOHN PLUMADORE
K992768 10/13/1999 NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE ANSELL PERRY JAMES R CHATTERTON
K992953 10/29/1999 SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM ANSELL PERRY JAMES R CHATTERTON
K992156 10/27/1999 SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES ANSELL PERRY JAMES R CHATTERTON
K992958 10/01/1999 ADVANTA GRAFT (<6MM) ATRIUM MEDICAL CORP. KAREN HALL
K992960 10/01/1999 ADVANTA GRAFT (>6MM) ATRIUM MEDICAL CORP. KAREN HALL
K992431 10/13/1999 NEO-2 METER AUTOMATA INSTRUMENTATION, INC. LINDA V MASANO
K992274 10/06/1999 MODIFICATION TO IMX HOMOCYSTEINE AXIS BIOCHEMICALS, ASA RONALD G LEONARDI
K992435 10/15/1999 BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER AZO ENTERPRISES NABIL AZO
K993138 10/20/1999 BALLARD MIC-KEY "G" LOW PROFILE GASTROSTOMY REPLACEMENT KIT BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN
K984590 10/07/1999 0.9% SODIUM CHLORIDE FLUSH SYRINGE BAXTER HEALTHCARE CORP. MARCIA MARCONI
K992734 10/01/1999 BECTON DICKINSON SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREG MORGAN
K992692 10/18/1999 EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS BENZ RESEARCH AND DEVELOPMENT CORP. JOSE A ORS
K993111 10/05/1999 ASCENT KNEE SYSTEM BIOMET MANUFACTURING, INC. MARY VERSTYNEN
K992899 10/21/1999 BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K993159 10/14/1999 MAXIM KNEE SYSTEM BIOMET, INC. TRACY J BICKEL
K993025 10/08/1999 MODIFICATION TO BONE MULCH SCREW SYSTEM BIOMET, INC. FRED MCCLURE
K992351 10/08/1999 SEALOUETTE FIBRIN SEALANT APPLICATOR BIOSURGICAL CORP. TERRY E LAAS
K993192 10/27/1999 ILLUSION BISCO, INC. KATHEYN B PATTERSON
K992309 10/07/1999 INTRODUCER SHEATH, VESSEL DILATOR BOSTON SCIENTIFIC CORP. SUSAN POOL
K991687 10/07/1999 MODIFICATION TO LINER II: SOFT RELINE LIQUID BOSWORTH CO. MILDRED M GOLDSTEIN
K992468 10/20/1999 BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER BRAUN GMBH LAURA GUY
K992898 10/21/1999 THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM BRIGHT MEDICAL INSTRUMENTS ROBERT E SIMONSON
K992666 10/13/1999 VIDEO PLUS SYSTEM, SERIES 95000 CAMTRONICS, LTD. ROBERT KRIEDERMANN
K992547 10/13/1999 CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 CANON U.S.A., INC. KEN SHADOFF
K992696 10/07/1999 ECG MINIMONITOR, MODEL CG-5000 CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K991897 10/21/1999 CATHETER INNOVATIONS IMPLANTABLE PORT CATHETER INNOVATIONS, INC. ROGER L RICHINS
K992629 10/22/1999 D/SENSE II (GREEN-OR) DENTIN DESENSITIZER CENTRIX, INC. JOHN DISCKO
K993002 10/14/1999 CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 CERAMOPTEC, INC. CAROL J MORELLO
K992544 10/26/1999 TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM CIRCON CORP. RONALD J EHMSEN
K991452 10/07/1999 COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K992591 10/15/1999 CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS CODMAN & SHURTLEFF, INC. JAMES M FLAHERTY
K992542 10/27/1999 TUBULAR ELECTRODE DEVICE CONWAY STUART MEDICAL, INC. THOMAS WEHMAN
K992070 10/27/1999 COOK ULTRA QUIET VACUUM PUMP & REGULATOR COOK UROLOGICAL, INC. BRENDA DAVIS
K992347 10/08/1999 CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS CORDIS CORP. KAREN WILK
K993091 10/29/1999 PALMAZ XL TANSHEPATIC BILIARY STENTS CORDIS CORP. ARIEL MACTAVISH
K992673 10/12/1999 VISTA BRITE TIP CATHETERS CORDIS CORP. DENNIS S GRIFFIN
K993266 10/28/1999 PROWLER PLUS INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K991531 10/04/1999 CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 CORDIS WEBSTER, INC. MARY ADAMS
K991385 10/25/1999 DADE BEHRING N HIGH SENSITIVITY CRP ASSAY DADE BEHRING, INC. REBECCA S AYASH
K983616 10/15/1999 DAIWA MODEL 180 DAIWA PRODUCTS, INC. E.J. SMITH
K993098 10/08/1999 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 DATA MEDICAL ASSOCIATES, INC. THOMAS G DOLLAR
K992956 10/06/1999 LUCITONE FRS FLEXIBEL DENTAL RESIN DENTSPLY INTL. P. JEFFERY LEHN
K992519 10/22/1999 NRC NON-RINSE CONDITIONER DENTSPLY INTL. P. JEFFERY LEHN
K993089 10/14/1999 DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER DEROYAL CARDIOVASCULAR, INC. LOIS MARSH
K993178 10/18/1999 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K993294 10/25/1999 DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING, PH.D
K993212 10/22/1999 DRYASOL ACID CONCENTRATE MIX DIASOL, INC. MONICA ABELES
K992653 10/27/1999 SHELLY PROTECTED AV FISTULA NEEDLE DIASOL, INC. MONICA ABELES
K990023 10/25/1999 HYBRID CAPTURE II CT-ID TEST DIGENE CORP. MARK DEL VECCHIO
K990372 10/14/1999 MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY DR. FRITZ GMBH JAMES CHITTY
K990396 10/01/1999 T-ANASTAFLO EDWARDS LIFESCIENCES RESEARCH MEDICAL JOHN W SMITH
K992847 10/14/1999 HICHEM BUN REAGENT ELAN HOLDINGS, INC. WYNN STOCKING
K992845 10/18/1999 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT ELAN HOLDINGS, INC. WYNN STOCKING
K992846 10/18/1999 HICHEM TOTAL PROTEIN REAGENT ELAN HOLDINGS, INC. WYNN STOCKING
K991281 10/27/1999 ELECTRIC MOBILITY "CAVALIER SCOOTERS" ELECTRIC MOBILITY CORP. MARK HOSKIN
K991857 10/07/1999 AIRFLOW HANDY ELECTRO MEDICAL SYSTEMS, INC. CYNTHIA J.M. NOLTE
K992333 10/08/1999 EBI OMEGA 21 SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K992382 10/14/1999 SURGITRON RADIOLASE ELLMAN INTL., INC. FRANK LIN
K992450 10/07/1999 EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS EMORY UNIVERSITY ERNEST V GARCIA
K991601 10/28/1999 DUAL LUMEN CATHETER, MODEL DL-35-90 ENDOLOGIX, INC. KAREN U SALINAS
K992394 10/15/1999 BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT ENDOTEC, INC. JOHN PAPPAS
K992769 10/14/1999 ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- ERBE USA, INC. SCOTT CUNDY
K992764 10/14/1999 ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 ERBE USA, INC. SCOTT CUNDY
K984465 10/27/1999 OXYCONALPHA WITH OPTION ECG ERICH JAEGER B.V. LEON DEN BAKKER
K992966 10/07/1999 REFERENCE ESPE DENTAL AG ANDREAS PETERMANN
K992612 10/14/1999 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 ETHICON ENDO-SURGERY, INC. EDWIN O BILLIPS
K992527 10/13/1999 URETERO-RENOSCOPE FIBER IMAGING TECHNOLOGIES, INC. JOSEPH RESS
K990401 10/15/1999 FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER FUKUDA DENSHI USA, INC. SUSAN D GOLDSTEIN-FALK
K993064 10/06/1999 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO RENAL CARE PRODUCTS WILLIAM M TOWNSEND
K993090 10/01/1999 SILHOUETTE FC GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K991014 10/20/1999 CASE 8000 EXERCISE TESTING SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LAURA L MCCOMIS
K990638 10/07/1999 ANEROID SPHYGMOMANOMETER GENMED, INC. EDWARD HYER
K993132 10/04/1999 GENZYME DIRECT AMYLASE VERIFIER GENZYME CORP. BARBARA PIZZA
K992766 10/18/1999 N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET GENZYME CORP. BARBARA PIZZA
K992145 10/14/1999 ECOMED SCALP VEIN SET GREINER MEDITECH, INC. DOUGLAS L HARRIS
K992319 10/08/1999 RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM GUIDANT CORP. SANDRA SUNDELL
K992618 10/29/1999 RESPALERT HARWILL MEDICAL (PTY) LTD. E.J. SMITH
K992971 10/18/1999 REP CHOLESTEROL PROFILE KIT HELENA LABORATORIES ERIC PETERSON
K991563 10/13/1999 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C HENKE SASS WOLF OF AMERICA, INC. ELLEN HENKE
K992985 10/14/1999 GLUMA COMFORT BOND HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K992292 10/01/1999 GLUMA COMFORT BOND + DESENSITIZER HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K993171 10/21/1999 HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A HEWLETT-PACKARD CO. DAVE OSBORN
K992478 10/15/1999 PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A HEWLETT-PACKARD, HEALTHCARE SOLUTIONS GROUP SHEILA W PICKERING
K992650 10/08/1999 AIRIS, AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K991214 10/14/1999 SIMPLICARE TRANSPARENT WOUND DRESSING HOLLISTER, INC. JOSEPH S TOKARZ
K992775 10/01/1999 OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W HOLOGIC, INC. NANDINI MURTHY
K991132 10/20/1999 ACTIVA HOVEROUND CORP. STAN COOPER
K993004 10/06/1999 ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K993181 10/22/1999 HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K993077 10/08/1999 HOWMEDICA OSTEONICS RESTORATION HA HIP STEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K993009 10/25/1999 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY HYDROCISION, INC. DEBBIE IAMPIETRO
K984313 10/22/1999 HTU3 HYOX SYSTEMS LTD. HOWARD M HOLSTEIN
K992714 10/05/1999 MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 HYSTERX, INC. JUDY F GORDON
K991543 10/25/1999 INTRAOP CATHETER I-FLOW CORP. STANLEY E FRY
K991853 10/25/1999 INTERACOUSTICS EP 15 ABR STAND ALONE UNIT IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) DONNA WARD
K992796 10/25/1999 ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 IMAGE-GUIDED NEUROLOGICS, INC. MICHAEL RENNER
K992878 10/15/1999 ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K992334 10/08/1999 ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K992409 10/08/1999 THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ IMPLEX CORP. JOHN SCHLAGO
K992695 10/18/1999 INSURE PRO TEST INBIOS INTL., INC. ESTELA RAYCHAUDHURI
K992262 10/04/1999 INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM INDIGO MEDICAL, INC. JACQUELYN A HUGHES
K992410 10/15/1999 ACTITRAC INDIVIDUAL MONITORING SYSTEMS, INC. DAVID T KRAUSMAN
K992575 10/07/1999 CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 INFIMED, INC. RALPH J FLATAU
K992458 10/14/1999 RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K992377 10/08/1999 RC TACK INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K992983 10/07/1999 BAHO AUTOCLAVABLE CYSTOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, LLC. GERALD GOIGITZER
K992369 10/13/1999 SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 INTERPORE CROSS INTL. LYNN M RODARTI
K992816 10/15/1999 MODIFICATION TO INTRASTENT INTRATHERAPEUTICS, INC. CATHY YOHNK
K992643 10/27/1999 MODEL IRC 1001 AEROSOL COMPRESSOR INVACARE CORP. EDWARD A KROLL
K983627 10/22/1999 VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM INVACARE CORP. EDWARD A KROLL
K991025 10/15/1999 LUMA-CATH FIXED CURVE EP CATHETERS IRVINE BIOMEDICAL, INC. ROGER TU
K990787 10/20/1999 TRIO 300 ITO CO., LTD. T. WHIT ATHEY
K992649 10/29/1999 ATD AUTOMATIC BRIDGE REMOVER J. MORITA USA, INC. KEITH A BARRITT
K993136 10/21/1999 JEL BIOS 10 (CODE NAME RD-1801) J.F. JELENKO & CO., INC. TRIDIB R DASGUPTA
K993152 10/21/1999 JEL BIOS 18 (CODE NAME RD- 1214) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K993173 10/26/1999 GOLD CORE 55 JENERIC/PENTRON, INC. ANNMARIE TENERO
K993175 10/26/1999 GOLD CORE 75 JENERIC/PENTRON, INC. ANNMARIE TENERO
K992484 10/14/1999 RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG JORDCO, INC. HAL J OIEN
K993345 10/25/1999 K-ASSAY APO AI KAMIYA BIOMEDICAL CO. COLIN GETTY
K993354 10/28/1999 K-ASSAY APO B KAMIYA BIOMEDICAL CO. COLIN GETTY
K992469 10/15/1999 KSEA SCBCOM KARL STORZ ENDOSCOPY KEVIN A KENNAN
K991203 10/15/1999 IRRIGATION OR INFUSION PUMP "K" PUMP KMI KOLSTER METHODS, INC. ALWIN H KOLSTER
K992586 10/29/1999 KONICA LASER IMAGER, DRYPRO MODEL 722 KONICA CORP. KAY HAMAGUCHI
K982521 10/26/1999 SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES LEONHARD LANG CO. BURRHUS LANG
K993373 10/27/1999 ROTORBLADE SUTURE ANCHOR LI MEDICAL TECHNOLOGIES, INC. RHODEMANN LI
K990141 10/19/1999 LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 LIGHT DIAGNOSTICS CINDY PENNY
K990738 10/29/1999 DR. JAHANGER'S CUTTER M.S. JAHANGER, MD MOHAMMED JAHANGER
K991914 10/06/1999 SUPER SOOTHER MART TILLER CORP. JIMMY DONG
K992340 10/08/1999 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE MASIMO CORP. JAMES J CRONIN
K992238 10/08/1999 MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) MASIMO CORP. JAMES J CRONIN
K992865 10/13/1999 SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE MAXXIM MEDICAL JOYCE MOODY
K993080 10/20/1999 AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE MEDTEXX PARTNERS, INC. E. J SMITH
K993145 10/21/1999 MEDTRONIC AVE BRIDGE STENT MEDTRONIC AVE, INC. SUSAN WALTON
K990793 10/22/1999 ACCUGUIDE MUSCLE INJECTION MONITOR MEDTRONIC XOMED DAVID TIMLIN
K983864 10/08/1999 ETCO2 VITAL SIGNS MODULE MENNEN MEDICAL, INC. KENNETH RAICHMAN
K993341 10/25/1999 INTELLISYSTEM II COLOR MONITOR MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K993057 10/05/1999 MBA MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K991879 10/28/1999 SPRING-WOUND EPIDURAL CATHETER MICOR, INC. CHARLES W ESLEEP
K993257 10/21/1999 .010" SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014" SILVERSPED HYDROPHILIC GUIDEWIRE, .016" SILVERSPEED HYDROPHILIC GUIDEWI MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K991239 10/18/1999 VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 MICRON CORP. EIJI SUZUKI
K991456 10/25/1999 MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 MICROWAVE MEDICAL, INC. GREG HOLLAND
K990153 10/08/1999 VIRGO MRI SYSTEM MILLENNIUM TECHNOLOGY SERVICES DAVID W SCHLERF
K993233 10/15/1999 OBC-085 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K993279 10/15/1999 QSC-085 SHOULDER ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K993235 10/15/1999 QWH-085 WRIST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K992266 10/27/1999 IV ADMINISTRATION SET NEW ALLIANCE OF INDEPENDENT MEDICAL DISTRIBUTORS, EDWARD THIBON
K992742 10/14/1999 NEUROFAX, MODEL EEG-1100A NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K983793 10/05/1999 PREFERENCE TREATMENT SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K990990 10/07/1999 CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 NUCLETRON CORP. RALPH E SHUPING
K990324 10/05/1999 NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM NUVASIVE, INC. STEVE REITZLER
K992782 10/05/1999 NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES NUVASIVE, INC. STEVE REITZLER
K992466 10/04/1999 OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K992583 10/29/1999 MASS (MICRO-ACCESS SPINE SYSTEM) OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. MICHAEL PONTIUS
K991926 10/18/1999 OPAP OPAP, INC. WILLIAM T HART
K991140 10/25/1999 ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES ORATEC INTERVENTIONS, INC. SHEILA RAMERMAN
K992601 10/27/1999 TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K990986 10/14/1999 CONTOUR SPINAL SYSTEM ORTHO DEVELOPMENT CORP. CAROL FREASIER
K993068 10/04/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS MARLENE SHULMAN
K992366 10/08/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A SHULMAN
K992582 10/21/1999 PACIFIC IMPLANT TITANIUM ENDODONTIC POINT PACIFIC IMPLANT, INC. DANIEL J MANELLI
K992523 10/18/1999 HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W PAMITEX INDUSTRIES SDN BHD SAID AWANG
K993093 10/29/1999 HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) PAMITEX INDUSTRIES SDN BHD SAID AWANG
K993097 10/27/1999 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM PAMITEX INDUSTRIES SDN BHD SAID AWANG
K991474 10/06/1999 HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA PAMITEX INDUSTRIES SDN BHD AZMAN ISMAIL
K993287 10/29/1999 POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM PAN-CENTURY RUBBER PRODUCTS SDN. BHD. H.R.K. MURTHY
K992568 10/14/1999 PASCO MIC AND MIC/ID PANELS, CEFOTAXIME PASCO LABORATORIES, INC. LINDA K DILLON
K992562 10/13/1999 PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE PASCO LABORATORIES, INC. LINDA K DILLON
K992593 10/14/1999 PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL PASCO LABORATORIES, INC. LINDA K DILLON
K992647 10/19/1999 PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN PASCO LABORATORIES, INC. LINDO K DILLON
K992546 10/12/1999 PASCO MIC AND MIC/ID PANELS, MEROPENEM PASCO LABORATORIES, INC. LINDA K DILLON
K992646 10/19/1999 PASCO MIC AND MIC/ID PANELS, PENICILLIN PASCO LABORATORIES, INC. LINDA K DILLON
K992507 10/08/1999 PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN PASCO LABORATORIES, INC. LINDA K DILLON
K991658 10/08/1999 PERMOBIL POWERED WHEELCHAIR 1280 PERMOBIL A.B. BENGT PERSSON
K993165 10/20/1999 QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 PHAMATECH CARL A MONGIOVI
K992685 10/06/1999 QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C PHAMATECH CARL A MONGIOVI
K992533 10/18/1999 PHILIPS GYROSCAN INTERA (*) PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K992335 10/07/1999 BEACON-P, MODEL 211059 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. RONALD J MARTONE
K991256 10/08/1999 VIEWPOINT ENT/ORTHOPEDIC OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K991970 10/25/1999 SCAREASE SHEETS & SCAREASE GEL PILLAR SURGICAL ROB FRITZENKOTTER
K983808 10/14/1999 ZIPPY PILLAR TECHNOLOGY, INC. CHRIS TINSLEY
K992617 10/27/1999 HEX BUTTON PIONEER SURGICAL TECHNOLOGY BURNS SEVERSON
K992616 10/27/1999 SDB CERCLAGE SYSTEM PIONEER SURGICAL TECHNOLOGY BURNS SEVERSON
K983000 10/27/1999 CRICOTHYROTOMY TUBE POLAMEDCO, INC. JERRY W HARRER
K990276 10/01/1999 POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER POROUS MEDIA CORP. ROCHELLE M MICKSCHL
K991965 10/01/1999 PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES PURILENS, INC. RICHARD E LIPPMAN
K993088 10/08/1999 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI PURITAN BENNETT CORP. TONY KEAVENEY
K993220 10/22/1999 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM PURITAN BENNETT CORP. TONY KEAVENEY
K990977 10/06/1999 SERAQUEST EB VAC IGM QUEST INTL., INC. ROBERT A CORT
K990410 10/28/1999 SERAQUEST EB VCA IGG QUEST INTL., INC. ROBERT A CORT
K993100 10/06/1999 REDI-SCREEN REDWOOD BIOTECH, INC. JANIS FREESTONE
K993307 10/27/1999 ARIA LX CPAP SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K993433 10/27/1999 VIRTUOSO LX SMART CPAP SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K992926 10/26/1999 GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) RI MOS. S.R.L. ADENA S RIEMER
K990397 10/25/1999 FLEXIBLE FIBERSCOPES & ACCESSORIES RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K992830 10/27/1999 SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE SAFESKIN CORP. EUGENE V GOORCHENKO
K992426 10/13/1999 RAYPAX WEB CLINICAL SYSTEM SAMSUNG SDS CO., LTD CARL ALLETTO
K992760 10/25/1999 SELECT-SUTTER MICRO BIPOLAR FORCEPS SELECT MEDIZINTECHNIK HERMANN SUTTER GMBH ANITA THIBEAULT
K992272 10/01/1999 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI COSMOS CORP. SUSAN D GOLDSTEIN-FALK
K992271 10/01/1999 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES SHANGHAI COSMOS CORP. SUSAN D GOLDSTEIN-FALK
K983613 10/27/1999 PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES SHANGHAI JIATAI PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K992861 10/06/1999 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD SUSAN D GOLDSTEIN-FALK
K992555 10/14/1999 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT KAREN ABEL
K992922 10/06/1999 SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. GUI-XI LIU
K993240 10/27/1999 SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K993231 10/27/1999 SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K992880 10/19/1999 P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC. LISA J STONE
K992471 10/22/1999 SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 SIMS PORTEX, INC. TIMOTHY J TALCOTT
K990233 10/27/1999 ST-302 INFRAREX SKYLARK DEVICE CO., LTD. GEORGE K. C CHEN
K993269 10/27/1999 IQ NASAL MASK, MODEL P/N 50160 SLEEPNET CORPORATION PAUL R CHIESA
K990723 10/05/1999 DYONICS VARICOSE VEIN ABLATION BLADE SMITH & NEPHEW, INC. DEBORAH CONNORS
K991026 10/22/1999 REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS SMITH & NEPHEW, INC. EHAB M ESMAIL
K992269 10/25/1999 VENTIL-A ORAL PROTECTOR SOMATICS, INC. RICHARD ABRAMS
K993265 10/22/1999 SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 SORING GMBH MEDIZINTECHNIK CARL ALLETTO
K991280 10/20/1999 125 IMPLANT SEEDS, MODEL STM1251 SOURCETECH MEDICAL, L.L.C. DAVID T SIERACKI
K992127 10/04/1999 CARDIOQUANT TROPONIN I TEST SPECTRAL DIAGNOSTICS, INC. FRANCEE S BOCHES
K990713 10/22/1999 SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER SPECTRANETICS CORP. MICHAEL J QUINN
K992522 10/26/1999 SPECTRUM DESIGNS SPECTRAGEL SPECTRUM DESIGNS, INC. JIM DISHMAN
K992460 10/05/1999 CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY STARION INSTRUMENTS GEORGE HERMANN
K992698 10/25/1999 STENTOR, PAGEVIEW STENTOR, INC. GARY J ALLSEBROOK
K993045 10/27/1999 BARIATRIC LAPAROSCOPE, MODEL 367 STRYKER ENDOSCOPY ROBERT H DAHLA
K991696 10/25/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K993148 10/15/1999 STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA STRYKER INSTRUMENTS SUZANNE VELAZQUEZ
K992056 10/12/1999 ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 SULZER CARBOMEDICS, INC. ROBERT M WOLFARTH
K992276 10/01/1999 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM SULZER SPINE-TECH JANELL A COLLEY
K993258 10/27/1999 SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES SUPERMAX SDN BHD STANLEY THAI
K992354 10/12/1999 SNT IMAGE ANALYSIS SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K992195 10/08/1999 QUANTEC-E IRRIGATION SYSTEM 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K992837 10/25/1999 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) SYNTHES (USA) ANGELA J SILVESTRI
K990637 10/22/1999 SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD SYNTHES (USA) ANGELA SILVESTRI
K993491 10/29/1999 QUICKPAC II ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K993490 10/29/1999 QUICKSTRIP ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K992907 10/05/1999 INTRADUCER TAUT, INC. RONALD KENSETH
K992904 10/05/1999 MINI-PORT TAUT, INC. RONALD KENSETH
K992536 10/08/1999 TECHNOSANAT KRYO TSK 2005 TECHNOSANAT INNOVATIVE MEDIZINTECHNIK GMBH WILLIAM KELLEY
K992627 10/25/1999 FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 TEFTEC CORP. THOMAS E FINCH
K992628 10/25/1999 FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 TEFTEC CORP. THOMAS E FINCH
K992425 10/19/1999 TES-20 TES ELECTRICAL ELECTRONIC CORP. MIKE Z CHEN
K992841 10/29/1999 TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES TG MEDICAL SDN BHD WEE-CHAI LIM
K992360 10/12/1999 TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES TG MEDICAL SDN BHD WEE-CHAI LIM
K992372 10/13/1999 THE LEADAWAY THERAPY EQUIPMENT, INC. GLENN BUCHAN
K993038 10/07/1999 TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIANA THORSON
K992723 10/18/1999 ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM TRANSFUSION TECHNOLOGIES CORP. JOHN J SOKOLOWSKI
K992574 10/29/1999 OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A TRIMEDYNE, INC. SUSAN H GAMBLE
K992416 10/15/1999 PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE U.S. BIOMATERIALS CORP. ALBERT FOSMOE
K992380 10/13/1999 ENDO-EZE MOTOR AND HANDPIECE ULTRADENT PRODUCTS, INC. SCOTT E MOORE
K992097 10/26/1999 ENDOREZ ULTRADENT PRODUCTS, INC. SCOTT E MOORE
K993055 10/05/1999 DEXIDE BIPOLAR FORCEPS II** DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER A GRAHAM
K992784 10/27/1999 NEXT GENERATION RODDING SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC LUIS NESPRIDO
K992442 10/05/1999 V.T.S., INC. (V.T.-3) V.T.S.,INC. DENNIS BELL
K991918 10/29/1999 NUTRISAFE EXTENSION TUBE VYGON CORP. ROBERT SCHIFF
K992679 10/21/1999 SURGEON "POWDER-FREE" GLOVES, LATEX, STERILE WEAR SAFE MALAYSIA SDN. BHD. CLAUDE COTTET
K992560 10/29/1999 MAPS 10000 WEB LINK MEDICAL MELISSA MAHALL
K990750 10/15/1999 DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE WRP SPECIALTY PRODUCTS SDN. BHD. CHENG HEAN KHOO
K990752 10/18/1999 DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE WRP SPECIALTY PRODUCTS SDN. BHD. CHENG HEAN KHOO
K992603 10/25/1999 XRT 600 R/F, WRF 0600 WUESTEC MEDICAL, INC. BRENDA S DAVIS
K992869 10/07/1999 XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE XOMED, INC. MARTIN D SARGENT
K992667 10/27/1999 ZMR HIP SYSTEM-REVISION TAPER ZIMMER, INC. KAREN CAIN
K991556 10/21/1999 ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL MEDICAL CORP. PAUL DIAS


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