FDA 510(k) Decisions During October, 1998  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K982893 10/26/1998 3M TEGASORB HYDROCOLLOID DRESSING 3M COMPANY ANNA E MCRIGHT
K982892 10/26/1998 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M COMPANY ANNA E MCRIGHT
K983027 10/02/1998 TRIMETHOPRIM/SULPHAMETHOXAZOLE AB BIODISK ANNE BOLMSTROM
K981791 10/23/1998 MG ABBOTT LABORATORIES MARK LITTLEFIELD
K981295 10/01/1998 UPRO ABBOTT LABORATORIES MARK LITTLEFIELD
K982786 10/16/1998 TRACCELL 2000 SLIDE MAPPING SYSTEM ACCUMED INTL., INC. NORMAN J PRESSMAN
K980485 10/21/1998 ISOLA SPINAL SYSTEM ACROMED CORP. WILLIAM CHRISTIANSON
K974892 10/13/1998 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 ACUTEK ADHESIVE SPECIALTIES, INC. GREG HOLLAND
K974891 10/21/1998 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 ACUTEK ADHESIVE SPECIALTIES, INC. GREG HOLLAND
K974890 10/13/1998 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 ACUTEK ADHESIVE SPECIALTIES, INC. GREG HOLLAND
K982793 10/28/1998 PIEZO TRONIC ADVANCED MEDICAL DEVICES, INC. GREG HOLLAND
K982890 10/26/1998 ADVANCED UROSCIENCE INJECTION NEEDLE ADVANCED UROSCIENCE, INC. KAREN E PETERSON
K980484 10/02/1998 AESCULAP SPINE SYSTEM EVOLUTION AESCULAP, INC. LIA SPASARO
K982914 10/02/1998 AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS AESCULAP, INC. LIA S JONES
K980186 10/07/1998 ZYMED TELEMETRY SYSTEM AGILENT TECHNOLOGIES DUDLEY HARRIS
K974248 10/07/1998 WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM AIR-SHIELDS, INC. MARCI L GOLDFINGER
K983002 10/16/1998 MYSTIQUE ULTRASONIC NEBULIZER AIRSEP CORP. EDWARD VRANA
K983053 10/21/1998 ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) ALDEN OPTICAL LABS., INC. MARTIN DALSING
K982896 10/21/1998 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 ALEXANDER MFG. CO. KEN HEIMENDINGER
K982131 10/29/1998 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE ANSELL EDMONT INDUSTRIAL, INC. MIKE W HAGANS
K982862 10/21/1998 RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE APPLICARE MEDICAL IMAGING, B.V. T. WHIT ATHEY
K982785 10/15/1998 FILM DIGITIZER MODEL 2905 ARRAY CORP. TAKASHI INAMI
K980907 10/16/1998 AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY AXIS BIOCHEMICALS, ASA RONALD G LEONARDI
K980812 10/01/1998 IMX HOMOCYSTEINE AXIS BIOCHEMICALS, ASA RONALD G LEONARDI, PH.D.
K983406 10/19/1998 SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR BANTA HEALTHCARE GROUP, LTD. RICHARD PEPPARD
K982566 10/21/1998 AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) BAR - ADVANCED CONTROL SYSTEMS LTD. AHAVA STEIN
K982690 10/06/1998 BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE BARCO NV FRANK FERGUSON
K982820 10/08/1998 BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K983321 10/06/1998 MICROFUSE DUAL RATE INFUSER BAXA CORP. WILLIAM E MCKAY
K982714 10/22/1998 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY BAYER CORP. GABRIEL J MURACA, JR.
K983709 10/28/1998 SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 BECKMAN COULTER, INC. LUCINDA STOCKERT
K982935 10/14/1998 SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR BECKMAN COULTER, INC. LUCINDA STOCKERT
K982541 10/28/1998 VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 BECTON DICKINSON VACUTAINER SYSTEMS ANDREA HRONCICH
K983081 10/28/1998 BEGOPAL 300 BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
K983080 10/28/1998 AUROLLOYD KF BEGO U.S.A. WILLIAM OREMUS
K983082 10/28/1998 BEGOCER G BEGO U.S.A. WILLIAM OREMUS
K983078 10/23/1998 BEGOPAL BEGO U.S.A. WILLIAM OREMUS
K983077 10/23/1998 BIO PONTOSTAR BEGO U.S.A. WILLIAM OREMUS
K983079 10/23/1998 PLATINLLOYD 100 BEGO U.S.A. WILLIAM OREMUS
K982538 10/02/1998 BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K982441 10/09/1998 CCA-220 BENSON MEDICAL INSTRUMENTS CO. DAVID P MAYOU
K982723 10/28/1998 MAICO MA42 BERNAFON-MAICO, INC. SCOTT SAVRE
K981888 10/15/1998 SMOKE-EVAC BIO-MEDICAL DEVICES, INC. NICK HERBERT
K983162 10/09/1998 PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC BIO-VASCULAR, INC. DIANNA L GECK
K981634 10/13/1998 BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS BIOCIRCUITS CORP. SHEILA J RAMERMAN
K982778 10/21/1998 BIODERM FOAM WOUND DRESSING BIODERM, INC. GEORGE WORTHLEY
K982939 10/13/1998 BTF THIN FILM WOUND DRESSING BIODERM, INC. MARIE B TEIXEIRA
K980585 10/08/1998 MILLENNIUM BIOLASE TECHNOLOGY, INC. ANDREW I KIMMEL
K982497 10/16/1998 ARTHROTEK INTERFERENCE SCREW BIOMET, INC. MARY VERSTYNEN
K982545 10/19/1998 BMP CABLE SYSTEM BIOMET, INC. JULIE K RYAN
K982982 10/13/1998 MINI-FIXATOR FOR COLLES FRACTURES BIOMET, INC. JULIE K RYAN
K982953 10/21/1998 TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES BIOMET, INC. LONNIE WITHAM
K982245 10/06/1998 TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA BIOSITE INCORPORATED JOHN F BRUNI
K982444 10/06/1998 7250 ULTRASOUND IMAGING SYSTEM BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K982580 10/22/1998 BIRD MONITOR INTERFACE BIRD PRODUCTS CORP. NEIL BATTISTE
K983492 10/09/1998 BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K983510 10/27/1998 CHEMSTRIP 101 URINE ANALYZER BOEHRINGER MANNHEIM CORP. JENNIFER TRIBBETT
K982948 10/27/1998 ELECSYS PSA, MODEL # ELECSYS 1010 BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K982949 10/27/1998 ELECSYS PSA, MODEL 2010 BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K983416 10/21/1998 ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 BOEHRINGER MANNHEIM CORP. LUANN OCHS
K980724 10/16/1998 TINAQUANT B 2-MICROGLOBULIN ASSAY BOEHRINGER MANNHEIM CORP. JULIE LINGENFELTER
K982508 10/16/1998 FLEXIMA BOSTON SCIENTIFIC CORP. DANIEL DILLON
K982888 10/20/1998 VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM BOSTON SCIENTIFIC CORP. CHRISTINE M HARRIS
K981445 10/05/1998 ULTIMA AIRFLOW SENSOR, 0510 BRAEBON MEDICAL CORP. RICHARD A BONATO
K981508 10/29/1998 VECTORVISION SPINE MODULE BRAINLAB, AG STEFAN VILSMEIER
K981660 10/16/1998 BARD 8FR., 40CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS, BAR 7FR., 30CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS C.R. BARD, INC. SANDRA PERREAND
K974713 10/14/1998 BARD HYDROPHILLIC COATED GUIDE WIRE C.R. BARD, INC. FRED BOUCHER
K981697 10/14/1998 CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE HEART, INC. JOHN D GREENBAUM
K982835 10/29/1998 ELECTRODE SWITCHBOX, MODEL 11-081002 CARDIMA, INC. JACK P DOUGLAS
K983052 10/19/1998 PERITRON PERINEOMETER MODEL 9300V OR 9300A CARDIO DESIGN PTY. LTD. NEVILLE MOTLEY
K982487 10/14/1998 CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO CARDIOPULMONARY TECHNOLOGIES, INC. MARK S STORSVED
K983058 10/21/1998 CERALAS D LASER SYSTEM, MODEL # CERALAS D15 CERAMOPTEC, INC. JONATHAN S KAHAN
K982761 10/22/1998 JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 CHAMCO, INC. JIM CUMMINS
K982680 10/15/1998 CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY CHIRON DIAGNOSTICS CORP. William J Pignato
K981613 10/26/1998 COBE SMARXT TUBING AND CONNECTORS COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K982406 10/07/1998 COBE VACUUM RELIEF CHECK VALVE COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K974774 10/16/1998 ENVY GUIDING CATHETER COOK, INC. APRIL LAVENDER
K983023 10/01/1998 MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ARIEL MACTAVISH
K980799 10/28/1998 HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL COSMEDENT, INC. MICHAEL O'MALLEY
K981709 10/13/1998 COAGULATION FACTOR V DEFICIENT PLASMA DADE BEHRING, INC. MARIO A LOWE
K982871 10/13/1998 DRUG CALIBRATOR II DADE BEHRING, INC. REBECCA S AYASH
K983548 10/27/1998 FERRITIN CALIBRATOR DADE BEHRING, INC. CATHY P CRAFT
K982299 10/19/1998 SPYGLASS 5 FR ANGIOGRAPHIC CATHETER DAIG CORP. MICHAEL G SCHULTZ
K973985 10/30/1998 AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) DATEX-ENGSTROM, INC. JOEL KENT
K982593 10/22/1998 LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE DENTALEZ GROUP KEITH C PEITHMAN
K982564 10/06/1998 DELTON FS DIRECT DELIVERY SYSTEM DENTSPLY INTL. P.JEFFERY LEHN
K983265 10/26/1998 DEPUY ACE COMPOSITE LOCKING NUT DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K982585 10/05/1998 DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K982918 10/05/1998 DEPUY C-STEM SYSTEM DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K982662 10/28/1998 DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K983391 10/15/1998 IMMULITE 2000 OM-MA MODEL L2KOP2 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K981084 10/07/1998 URISCREEN DIATECH DIAGNOSTICS,INC. FRAN WHITE
K982966 10/19/1998 DISETRONIC PEN DISETRONIC MEDICAL SYSTEMS Lee Leichter
K982789 10/29/1998 MEDICAL AIR COMPRESSOR, MODEL # 8413419 DRAGER, INC. HARALD KNEUER
K982484 10/08/1998 EBI VUECATH ENDOSCOPIC SPINAL SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K982676 10/29/1998 AIRWATCH II ZONE ENACT HEALTH MANAGEMENT SYSTEMS JAMES LYON
K982675 10/29/1998 AIRWATCH II ZONELESS ENACT HEALTH MANAGEMENT SYSTEMS JAMES LYON
K983316 10/21/1998 ULTRACISION 5MM INSTRUMENTS ETHICON ENDO-SURGERY, INC. CHUCK TABRI
K982479 10/14/1998 EXCEL AMBULATORY EEG EXCEL TECH. LTD. JOHN R MUMFORD
K980828 10/22/1998 EXMOOR MYRINGOTOMY KIT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K982642 10/21/1998 ECHO-SCREEN FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. DAVID G WOOD
K982636 10/26/1998 PATIENT WARMER- MODEL PW810 FISHER & PAYKEL HEALTHCARE, LTD. CHRIS MANDER
K982576 10/22/1998 FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 FRIATEC AG EUGENE GOORCHENKO
K982818 10/21/1998 HOSPAL TIPSTOP GAMBRO HEALTHCARE JEFFREY R SHIDEMAN
K983436 10/29/1998 GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM GAMMAMED USA JOHN J MUNRO III
K982695 10/19/1998 GC RELINE GC AMERICA, INC. TERRY L JORITZ
K982196 10/06/1998 DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K982772 10/15/1998 SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K981360 10/15/1998 VINYL PATIENT EXAMINATION GLOVE, POWDERED GLORMED INTL., INC. JANNA TUCKER
K974395 10/22/1998 ATLANT'S GRAD-LINE CORP. WALTER L WASSERMAN
K982999 10/16/1998 GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K982998 10/21/1998 GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K981861 10/01/1998 LINER 1:HARD RELINE LIQUID HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K983409 10/16/1998 V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 HDC CORP. JAMES S ABILLA
K983067 10/30/1998 FINE-JECT HENKE SASS WOLF OF AMERICA, INC. ELLEN J HENKE
K982670 10/02/1998 CONTEMPORARY ACETABULAR COMPONENT HOWMEDICA CORP. FRANK MAAS
K982531 10/16/1998 HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM HOWMEDICA CORP. JOHN DICHIARA
K982873 10/21/1998 ZETA MULTIZONE SCN LOCKING NAIL HOWMEDICA CORP. VIVIAN KELLY
K982824 10/29/1998 X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID I.E.D., INC. DONALD R REILLY
K982492 10/15/1998 IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES IMCOR ADRIAN COOPER
K982412 10/09/1998 MODIFICATION OF CRIT-LINE MONITOR III (CLM III) IN-LINE DIAGNOSTICS CORP. MATTHEW L HAYNIE
K982417 10/07/1998 INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP INNERDYNE, INC. RICK GAYKOWSKI
K982428 10/09/1998 CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) INNERVISION, INC. FRANK M LEWIS
K983056 10/13/1998 INNOVASIVE TIBIAL FASTENER INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K982603 10/07/1998 QUANTA LITE CHROMATIN ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981591 10/09/1998 VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT INTERNATIONAL REGULATORY CONSULTANTS DONALD F GRABARZ
K982064 10/05/1998 ACTION STORM RANGER II, ACTION STORM POWER 9000 INVACARE CORP. EDWARD A KROLL
K974581 10/28/1998 MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT INVIVO RESEARCH, INC. FRANCIS CASEY
K982255 10/22/1998 MODEL 2000 PULSE OXIMETER IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K981490 10/22/1998 WILLI GELLER CREATION PORCELAIN JENSEN INDUSTRIES, INC. JOHN SLANSKI
K980953 10/07/1998 ACCU-BITE HOME KIT DISCLUDER JEROME M. SIMON JEROME M SIMON
K983014 10/27/1998 SUMMIT ACETABULAR SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
K982905 10/05/1998 MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE KARL STORZ ENDOSCOPY KEVIN A KENNAN
K982658 10/15/1998 KSEA ENDOSCOPES FOR DENTAL PROCEDURES KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K983091 10/28/1998 ELAN-2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K982673 10/29/1998 JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM KEY WEST FRAGRANCE & COSMETIC AL WEISENBORN
K981345 10/01/1998 CHOLESTRON PRO II CHOLESTEROL TEST LIFESTREAM DIAGNOSTICS, INC. Erika B Ammirati
K983186 10/21/1998 BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR LINVATEC CORP. CAROL A WEIDEMAN
K982907 10/02/1998 MAGNATEK 40 MAGNA ADVANCED TECHNOLOGIES, INC. ANNIE VELEZ
K981024 10/06/1998 QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) MARQUETTE MEDICAL SYSTEMS, INC. KRISTIN PABST
K982624 10/26/1998 MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 MED-TEC,INC. DONALD F RIIBE
K983018 10/22/1998 ZINC PHOSPHATE CEMENT MEDENTAL INTL. DEBRA OLSON
K983109 10/06/1998 MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY MEDICAL ADVANCES, INC. THOMAS E TYNES
K983222 10/08/1998 PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 MEDICAL ADVANCES, INC. THOMAS E TYNES
K973970 10/06/1998 SPO2 FINGER PROBES MEDICAL CABLES, INC. CHRISTOPHER J FONTANA
K982548 10/19/1998 MLT 30 LASER MEDICAL LASER TECHNOLOGIES LTD. WILLIAM KELLEY
K983273 10/29/1998 XCT 2000 L PQCT BONE DENSITOMETER MEDICAL SYSTEMS, INC. TERRY SCHWALENBERG
K973198 10/14/1998 VGF-7 VASCULAR GRAFT FLOWMETER MEDICARD LTD. STEVEN A CLARKE
K981119 10/14/1998 CARDIOPAL MODEL NUMBER PM20 MEDICOMP, INC. JOSEPHUS RIFFE
K982659 10/07/1998 MEDIVISION HYSTEROSCOPE MEDIVISION SCOPE SERVICE CENTER, INC. WAYNE B STERNER
K982693 10/28/1998 MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K982916 10/29/1998 MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC MEDRAD, INC. JIM FERGUSON, JR.
K982814 10/09/1998 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC. JAN E DOBSCHA
K982220 10/15/1998 MODEL 2872 BIPOLAR LEAD ADAPTOR KIT MEDTRONIC VASCULAR BRIAN J EDWARDS
K982606 10/15/1998 AUROFLUID CPF METALOR DENTAL USA CORP. KENNETH A PUTNEY
K982013 10/21/1998 MGB LAPALUX TELESCOPE MGB ENDOSKOPISCHE GERATE GMBH BOB LEIKER
K982984 10/21/1998 ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS MICROLINE PENTAX, INC. JACQUELINE E MASSE
K983122 10/30/1998 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT MILL-ROSE LABORATORY ALAN C POJE
K983124 10/30/1998 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT MILL-ROSE LABORATORY ALAN C POJE
K983184 10/28/1998 MEPILEX MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K981048 10/07/1998 HYDRAGEL 6 CSF KIT MORAX BOREK JANIK, PH.D.
K974854 10/07/1998 HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 MORAX BOREK JANIK
K982970 10/28/1998 MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER MRI MANUFACTURING AND RESEARCH, INC. ED RANSON
K982082 10/28/1998 HANDISOL WOUND HEALING NATIONAL BIOLOGICAL CORP. FRANCIS D LAMM
K981958 10/19/1998 LEISEGANG VIDEO COLPOSCOPE NETOPTIX CORP. MARY MCNAMARA-CULLINANE
K982359 10/02/1998 NC-STAT NEUROMETRIX, INC. RENEE J THIBEAULT
K982577 10/21/1998 NEUFINISH RESURFACING CREAM NEUTROGENA CORP. YOHINI APPA
K982866 10/16/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K982766 10/30/1998 PASTE OPAQUE EX-3 NORITAKE CO., INC. MARSHA C WERTZBERGER
K982499 10/16/1998 COSMO PLUS WITH NICO, MODEL 8200 NOVAMETRIX MEDICAL SYSTEMS, INC. ROBERT H SCHIFFMAN
K981323 10/09/1998 COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE NOVARTIS NUTRITION CORP. ROBERT J LANG
K983785 10/29/1998 AUTOVENT 1000 O-TWO SYSTEMS INTL., INC. KEVIN BOWDEN
K983705 10/29/1998 EMT RESUSCITATOR O-TWO SYSTEMS INTL., INC. KEVIN BOWDEN
K983643 10/29/1998 GENESIS BLS O-TWO SYSTEMS INTL., INC. KEVIN BOWDEN
K982725 10/23/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE OLYMPUS AMERICA, INC. LAURA STORMS-TAYLOR
K982689 10/23/1998 WINSTATION RETINAL IMAGER OPHTHALMIC IMAGING SYSTEMS BETH A SOPER
K982358 10/02/1998 HISTOFREEZER DEVICE ORASURE TECHNOLOGIES, INC. R.SAM NIEDBALA
K982389 10/07/1998 ODC B2 BIPOLAR CUP ORTHO DEVELOPMENT CORP. CAROL FREASIER
K982598 10/02/1998 OTI FEMORAL LOCK TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K982886 10/05/1998 OTI MODULAR SHOULDER SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K983339 10/27/1998 OSTEO DYNATROC PROXIMAL FEMORAL NAIL OSTEONICS CORP. KATE SUTTON
K982936 10/21/1998 OSTEONICS EXTENDED FEMORAL BEARING HEAD OSTEONICS CORP. MARYBETH NAUGHTON
K980078 10/16/1998 PENETREASE P.T. PANCA PUSAKA DELI JANE CAMPBELL
K983381 10/19/1998 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS PARAGON TRADE BRANDS, INC. ROBERT J STAAB
K982691 10/09/1998 MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) PERUSAHAAN INTAN EMAS SDN. BHD. BIEN LONG NIEN
K982621 10/16/1998 QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 PHAMATECH CARL A MONGIOVI
K982533 10/22/1998 UNICAP GLIADIN IGA ASSAY PHARMACIA & UPJOHN CO. KAREN E MATIS
K982701 10/22/1998 UNICAP GLIADIN IGG ASSAY PHARMACIA & UPJOHN CO. KAREN E MATTIS
K982834 10/29/1998 RESTGRID PACKAGE/GYROSCAN NT PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K980820 10/13/1998 PHILIPS EASYGUIDE PHILIPS MEDICAL SYSTEMS, INC. FRANK GIANELLI
K982631 10/06/1998 PHILIPS TOMOSCAN CS PHILIPS MEDICAL SYSTEMS, INC. FRANK GIANELLI
K982128 10/23/1998 SHIKANI-FRENCH SPEAKING VALVE PILLING WECK SURGICAL ELIZABETH LAZARO
K982425 10/07/1998 CODA MPX30 MOTION ANALYSIS SYSTEM PINSCO INC. DBA B & L ENGINEERING LEE A BARNES
K980977 10/27/1998 PIOLAX HYDROPHILIC GUIDEWIRE PIOLAX MEDICAL DEVICES, INC. ELIZABETH BIERMAN
K983211 10/09/1998 CENTAURI PREMIER LASER SYSTEMS, INC. LISA MOJICA
K965136 10/16/1998 UROSURGE UROTHERM FLUID WARMING SYSTEM PRINCETON REGULATORY ASSOC. THOMAS BECZE
K981371 10/30/1998 LTV 1000 VENTILATOR PULMONETIC SYSTEMS, INC. DOUGLAS DEVRIES
K973138 10/28/1998 SPIROCARD QRS DIAGNOSTIC, LLC. KEVIN J DRISCOLL
K982281 10/16/1998 SERAQUEST RUBELLA IGM QUEST INTL., INC. ROBERT A CORT
K981597 10/09/1998 RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY RADIONICS, INC. LISA MISTERKA BENATI
K982489 10/05/1998 RFG-3C PLUS RADIONICS, INC. JEFFREY R MANNION
K981208 10/21/1998 TFR RAMCO LABORATORIES, INC. JEFFREY B GRUBB
K983107 10/22/1998 VFE RAMCO LABORATORIES, INC. JEFFREY B GRUBB
K982563 10/06/1998 ULTRAPRO MODEL 98 RAMSOFT, INC. NAGANATHA S RAMANATHAN
K982530 10/16/1998 SULLIVAN MIRAGE FULL FACE MASK RESMED LTD. SCOTT DUDEVOIR
K981841 10/13/1998 BREATHE EASY, MODELS AD AND CD RESPIRAID LTD. SHOSHANA FRIEDMAN
K982550 10/05/1998 BROWSER (EVENT SOFTWARE) MODEL # 4500E RESPIRONICS, INC. BETSY CORTELLONI
K982848 10/01/1998 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC. MARIA FEIJOO
K983387 10/09/1998 ONTRAK TESTCUP AND TESTSTIK CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC. MARIA FEIJOO
K983037 10/20/1998 ROEKO SEAL ROEKO ULM, ROESCHEISEN GMBH & CO. JAMES DELANEY
K981630 10/01/1998 VYGON DOUBLE LUMEN UMBILICAL CATHETER SCHIFF & CO. ANNE M CESARIO
K982592 10/21/1998 DOCKING-EXTENSION WIRE SCHNEIDER (EUROPE) GMBH THOMAS THALER
K982913 10/19/1998 ZINFOS ZINC PHOSPHATE CEMENT SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K983447 10/29/1998 WISE (II) IMAGE MANAGEMENT SYSTEM SECTRA-IMTEC AB HERMAN OOSTERWIJK
K981096 10/29/1998 SEMPERMED SURGEONS' GLOVES - SUPREME SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT RICHARD EHRENFELDNER
K981366 10/30/1998 STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES SENSORMEDICS CORP. LARRY MURDOCK
K982931 10/21/1998 THREADED FIXATION PIN SGARLATO LABORATORIES, INC. THOMAS SGARLATO
K982687 10/09/1998 DISPOSABLE VINYL EXAM GLOVES, POWDERED SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K982810 10/28/1998 SHELHIGH NO-REACT VASCUPATCH SHELHIGH, INC. SHLOMO GABBAY
K982879 10/15/1998 SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY SHIELD DIAGNOSTICS, LTD. EILEEN A MCCAFFERTY
K983207 10/30/1998 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD SUSAN D GOLDSTEIN-FALK
K982583 10/05/1998 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL SHIMADZU CORP. MICHAEL FISHBACK
K983327 10/09/1998 ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. DURKHANI ROSHAN
K982387 10/06/1998 E.CAM EXTRA HIGH ENERGY COLLIMATOR SIEMENS MEDICAL SOLUTIONS USA, INC. ANDREA DISANTI
K981528 10/28/1998 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. STEVE C HESLER
K982209 10/15/1998 ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 SIGMA DIAGNOSTICS, INC. WILLIAN R GILBERT
K983057 10/22/1998 ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH SHEILA M HEMEON-HEYER
K981034 10/30/1998 SILENT NIGHT II SLEEP SOLUTIONS, INC. LISA S JONES
K982849 10/05/1998 PANTHER WHEELCHAIR SNUG SEAT, INC. KIRK MACKENZIE
K982490 10/05/1998 TENOR SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K982990 10/21/1998 TSRH SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K982671 10/19/1998 SECURALLOY SPECIALITES SEPTODONT PETER S REICHERTZ
K980410 10/22/1998 SLE ELECTRODES AND ACCESSORIES SPECIALIZED LABORATORY EQUIPMENT, LTD. FRANK FERGUSON
K981004 10/21/1998 SLE EMG ELECTRODES AND ACCESSORIES SPECIALIZED LABORATORY EQUIPMENT, LTD. FRANK FERGUSON
K982679 10/07/1998 MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST SPECTRAL DIAGNOSTICS, INC. JOSEPH LAURINE
K982688 10/13/1998 SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK SPECTRUM DESIGNS, INC. JIM DISHMAN
K983258 10/21/1998 MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. TEENA M AUGOSTINO
K983260 10/21/1998 MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. TEENA M AUGOSTINO
K982225 10/28/1998 SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 SPIRACLE TECHNOLOGY GUY GANSEL
K982099 10/05/1998 MOMENTUM NO. FS008 WHEELCHAIR SRIRAM ENTERPRISES D.B.A. MOMENTUM GROUP RON MOSETICH
K982547 10/08/1998 STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR STERITEC PRODUCTS MFG. CO., INC. TOM ROLL
K981497 10/29/1998 STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS STERITEC PRODUCTS MFG. CO., INC. TOM ROLL
K982692 10/22/1998 STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC STERNGOLD/IMPLAMED PAMELA PAPINEAU
K982895 10/09/1998 STERNOMEGA COMPOMER CEMENT STERNGOLD/IMPLAMED PAMELA PAPINEAU
K982375 10/02/1998 STRYKER HIP ARTHOROSCOPY SET Stryker Endoscopy BALTAZAR ACOUSTA
K982903 10/21/1998 SULZER ORTHOPEDICS FLUTED STEMS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K982989 10/05/1998 QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR SUNRISE MEDICAL, INC. REBECCA ANDERSEN
K983639 10/25/1998 ZIPPIE GS, MODEL # EIZGS SUNRISE MEDICAL, INC. REBECCA ANDERSEN
K982917 10/16/1998 B-SYSTEM SILICONE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K982590 10/08/1998 TEMPBOND CLEAR-2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K983121 10/05/1998 NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 SYNTEC SCIENTIFIC CORP. TED Y SHI
K982732 10/08/1998 SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) SYNTHES SHERI L MUSGNUNG
K982987 10/21/1998 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES SPINE JONATHAN M GILBERT
K982470 10/14/1998 ECG ELECTRODES APRON TAPUZ MEDICAL TECHNOLOGY LTD. SHOSHANA FRIEDMAN
K971549 10/05/1998 VMT SYSTEM TARGET HEALTH, INC. JULES T MITCHEL
K972960 10/07/1998 HEALTH CHECK URI-TEST PROTEIN IN URINE TCPI, INC. FRAN WHITE
K982683 10/06/1998 TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION TELEX COMMUNICATIONS, INC. TOM SCHELLER
K982872 10/15/1998 TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TG MEDICAL SDN BHD W.C. LIM
K982991 10/21/1998 ANSPACH ACCESS CRANIAL PERFORATOR THE ANSPACH EFFORT, INC. LISA KREIDER
K981209 10/22/1998 MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS THE BINDING SITE, LTD. JAY H GELLER
K982133 10/22/1998 OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. RUTH C FORSTADT
K982733 10/28/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE THE OLYMPUS OPTICAL CO. LAURA STORMS-TAYLOR
K982734 10/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE THE OLYMPUS OPTICAL CO. LAURA STORMS-TAYLOR
K982787 10/21/1998 ASTEION CT SCANNER, TSX-021A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K981522 10/08/1998 AIA-PACK TGAB ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K981521 10/08/1998 AIA-PACK TPOAB ASSAY TOSOH MEDICS, INC. LON ROBINSON
K980906 10/06/1998 TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO TRANSONIC SYSTEMS, INC. CORNELIS J DROST
K983175 10/13/1998 EXTRA-CARE POWDER-FREE EXAMINATION GLOVE ULTRAWIN SDN BHD SIEW HOE MAH
K982699 10/20/1998 UNIGRAFE UNICARE BIOMEDICAL STAN YANG
K981207 10/28/1998 CLEARPLAN EASY FERTILITY MONITOR UNIPATH LTD. Louise Roberts
K983197 10/26/1998 SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON L MURPHY
K982783 10/05/1998 VAIL 1000 ENCLOSED BED VAIL PRODUCTS, INC. NANCY VAIL
K980601 10/21/1998 VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER VARIAN ASSOC., INC. LINDA NASH
K980590 10/22/1998 VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC. CHARLES H WILL
K981645 10/13/1998 TITANIUM HEMOSTATIC CLIP VITALITEC INT'L., INC. ELLEN HENKE-KNUPP
K973410 10/08/1998 ULTRACAM W. EDWARD JOHANSEN W. EDWARD JOHANSEN
K981744 10/14/1998 COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER W. KEITH THORNTON, D.D.S. W.KEITH THORNTON
K981565 10/15/1998 BIOCLEAR CONCENTRATE WAGGONER PRODUCT DEVELOPMENT MARK WAGGONER
K982604 10/23/1998 LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K982436 10/08/1998 RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R WOODSIDE BIOMEDICAL, INC. CAROL PATTERSON
K981880 10/20/1998 DX-480, ADD ON DIGITAL IMAGER WUESTEC MEDICAL, INC. DAVID ANDRESS
K983224 10/21/1998 XPS DRILL SYSTEM XOMED, INC. DAVID TIMLIN


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