FDA 510(k) Decisions During June, 1998  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K981325 06/11/1998 3M M.G. MATERIAL 3M COMPANY AMY E FOWLER
K974735 06/24/1998 STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE AARON MEDICAL INDUSTRIES J. ROBERT SARON
K980335 06/15/1998 ETEST BENZYLPENICILLIN AB BIODISK ANNE BOLMSTROM
K981135 06/09/1998 ETEST BENZYLPENICILLIN AB BIODISK ANNE BOLMSTROM
K981137 06/09/1998 ETEST CEFOTAXIME AB BIODISK ANNE BOLMSTROM
K981139 06/01/1998 ETEST CEFTRIAXONE AB BIODISK ANNE BOLMSTROM
K981138 06/05/1998 ETEST CIPROFLOXACIN AB BIODISK ANNE BOLMSTROM
K981136 06/09/1998 ETEST FOSFOMYCIN AB BIODISK ANNE BOLMSTROM
K981342 06/29/1998 ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY ABBOTT LABORATORIES JANICE E BROWN
K981758 06/12/1998 ALBG ABBOTT LABORATORIES MARK LITTLEFIELD
K981806 06/22/1998 ALKP ABBOTT LABORATORIES
K981467 06/22/1998 AMM ABBOTT LABORATORIES MARK LITTLEFIELD
K981216 06/08/1998 AMY ABBOTT LABORATORIES MARK LITTLEFIELD
K981843 06/29/1998 AST ABBOTT LABORATORIES MARK LITTLEFIELD
K981578 06/16/1998 CA ABBOTT LABORATORIES MARK LITTLEFIELD
K981476 06/25/1998 CHOL ABBOTT LABORATORIES MARK LITTLEFIELD
K981652 06/29/1998 CHOL ABBOTT LABORATORIES MARK LITTLEFIELD
K981840 06/08/1998 CO2 ABBOTT LABORATORIES MARK LITTLEFIELD
K981580 06/11/1998 HDL ABBOTT LABORATORIES MARK LITTLEFIELD
K981581 06/08/1998 IRON ABBOTT LABORATORIES MARK LITTLEFIELD
K981118 06/12/1998 PHOS ABBOTT LABORATORIES MARK LITTLEFIELD
K981759 06/16/1998 PHOS ABBOTT LABORATORIES MARK LITTLEFIELD
K981766 06/19/1998 URIC ACID ABBOTT LABORATORIES MARK LITTLEFIELD
K981131 06/26/1998 PATHFINDER MOBILE C ARM ACOMA MEDICAL IMAGING, INC. JAMES LAMBRECHT
K981227 06/30/1998 SYMPHONY 360 REMOTE CONTROL TABLE ACOMA MEDICAL IMAGING, INC. JIM LAMBRECHT
K981714 06/30/1998 TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM ACROMED CORP. MARY LEWIS
K973454 06/10/1998 AD-TECH'S SPINAL ELECTRODE AD-TECH MEDICAL INSTRUMENT CORP. CURTIS VAN ALLEN
K980867 06/04/1998 3D-MSPECT ADAC LABORATORIES DENNIS W HENKELMAN
K981291 06/29/1998 VANTAGE 3.0 INSYNCH ADAC LABORATORIES DENNIS W HENKELMAN
K980659 06/11/1998 DRYALYSATE CONCENTRATE ADVANCED RENAL TECHNOLOGIES, INC. ROBIN CALLAN
K980144 06/16/1998 HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER AEROTEL, LTD. GEORGE H MYERS
K980121 06/10/1998 AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS AESCULAP, INC. LIA SPASARO
K981196 06/17/1998 MEDITEC LINK AESCULAP-MEDITEC NORTH AMERICA WILLIAM T KELLEY
K981151 06/22/1998 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 ALCON LABORATORIES RALPH H LARSEN
K981103 06/23/1998 TURBOSONICS LIMITED REUSE ULTRASONIC TIP ALCON LABORATORIES MARTIN A KAUFMAN
K981252 06/23/1998 OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) ALDEN OPTICAL LABS., INC. MARTIN DALSING
K981728 06/26/1998 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 ALEXANDER MFG. CO. KEN HEIMENDINGER
K974769 06/12/1998 COSGROVE CLAMP ALLEGIANCE HEALTHCARE CORP. PATRICIA SHARPE-GREGG
K981121 06/30/1998 AMIGO RT AMIGO MOBILITY INTL., INC. ANDREA J LUPO
K964332 06/01/1998 EAGLE CENTURY STEAM STERILIZER AMSCO INTL., INC. PAUL ZAMECNIK
K980929 06/05/1998 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES ANSELL PERRY JAMES R CHATTERTON
K980375 06/09/1998 WINSCAN AUTOMATED IMAGING SYSTEM APPLIED IMAGING CORP. PATRICIA A MILBANK
K980836 06/29/1998 GENIE CUP INTEGRATED SCREENING DEVICE APPLIED TECHNOLOGY VENTURES, L.L.C. RICHARD ROBLIN
K981286 06/19/1998 SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS ARMM, INC. ROGER WOOD
K970689 06/04/1998 IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U ARROW INTL., INC. THOMAS D NICKEL
K973812 06/10/1998 ARTHREX PUDDU OSTEOTOMY SYSTEM ARTHREX, INC. SCOTT M DURLACHER
K963440 06/26/1998 DIALOG DIALYSIS MACHINE B. BRAUN MEDICAL AG MARK S ALSBERGE
K974468 06/22/1998 PHOTONIC STIMULATOR BALES SCIENTIFIC, INC. MAURICE BALES
K980591 06/24/1998 RENU MULTIPLUS LUBRICATING & REWETTING DROPS BAUSCH & LOMB, INC. KIM S DEVITTO
K981312 06/05/1998 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP. GABRIEL J MURACA, JR.
K981797 06/12/1998 B-D PEN ULTRA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K974363 06/03/1998 BECTON DICKINSON BLUNT PLASTIC CANNULA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K980987 06/11/1998 BECTON DICKINSON SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY MORGAN
K980580 06/25/1998 BECTON DICKINSON SYRINGES BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURIO
K981864 06/12/1998 ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 BECKMAN COULTER, INC. ELLEN M VOSS
K981638 06/12/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K981517 06/09/1998 CEFDINIR, 5 UG, SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS VIRGINIA C WEINKNECHT
K981013 06/17/1998 VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE BECTON DICKINSON VACUTAINER SYSTEMS EILEEN SCHWEIGHARDT
K981439 06/15/1998 CCA-200 BENSON MEDICAL INSTRUMENTS CO. DAVID P MAYOU
K981184 06/22/1998 SHARPTRACK REUSABLE SHARPS CONTAINER BFI- MEDICAL WASTE SYSTEMS A W SIEGNER
K974106 06/01/1998 ICON IMPLANT SYSTEM BIO SCIENCE TECHNOLOGIES, INC. ALAN DONALD
K981590 06/10/1998 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON BIO-RAD ELIZABETH PLATT
K981230 06/01/1998 ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K980983 06/09/1998 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOMEDICS CAROL E JONES
K980927 06/05/1998 LACTOSORB PANELS AND FASTENERS BIOMET, INC. MARY VERSTYNEN
K981752 06/15/1998 I-STAT COAGULATION CONTROL SET BIOPOOL INTL., INC. MICHAEL D BICK
K981333 06/22/1998 NITRILON CORRECT-TOUCH BIOPRO (M) SDN BHD MIKE KYLE
K981293 06/30/1998 7200 ULTRASOUND IMAGING SYSTEM BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K981243 06/29/1998 BIOSTRIDE FREE T4 EIA TEST KIT BIOSTRIDE DIAGNOSTICS, INC. JANIS FREESTONE
K974885 06/17/1998 BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM BLACKSTONE MEDICAL, INC. MATTHEW LYON
K980971 06/11/1998 BODYSTAT DUALSCAN 2005 BODYSTAT LTD. I J MEEUWSEN
K980887 06/29/1998 ELECSYS CEA ON THE ELECSYS 1010 BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K980002 06/18/1998 KOALA VASCULAR CLAMPS AND INSERTS BOSS INSTRUMENTS, LTD. BURNS PHILLIPS
K981669 06/04/1998 SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K972859 06/05/1998 FLUTTER D BRADSTREET CLINICAL RESEARCH ASSOC., INC. PATRICIA W BRADSTREET
K961320 06/25/1998 CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM BUCKMAN CO., INC. DAVID W SCHLERF
K974641 06/08/1998 FUTURELASE 3000/3002 ERBIUM LASER SYSTEM BUCKMAN CO., INC. DAVID W SCHLERF
K981172 06/30/1998 LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES BYRON MEDICAL STEVE BOLLINGER
K980738 06/16/1998 PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION BYRON MEDICAL STEVE BOLLINGER
K980850 06/03/1998 BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS C.R. BARD, INC. SANDRA PERREAND
K971214 06/11/1998 KILOWIN CADWELL LABORATORIES, INC. CARLTON CADWELL
K981779 06/24/1998 CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT CANTOR & SILVER LTD. MARTIN DALSING
K973298 06/26/1998 CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER CARDIMA, INC. SHELLEY TRIMM
K982174 06/24/1998 VENTURI VENTILATOR CARDIOPULMONARY CORP. JAMES W BIONDI
K981147 06/09/1998 CLEAR (TM) LICE EGG REMOVER SYSTEM CARE TECHNOLOGIES, INC. DANIEL J MANELLI
K981610 06/25/1998 CARESIDE ANALYZER CARESIDE, INC. KENNETH B ASARCH
K981588 06/23/1998 CARESIDE TOTAL BILIRUBIN CARESIDE, INC. KENNETH B ASARCH
K981604 06/25/1998 CARESIDE URIC ACID CARESIDE, INC. KENNETH B ASARCH
K981149 06/29/1998 LASETTE LASER SKIN PERFORATOR CELL ROBOTICS, INC. RONALD K LOHRDING
K981214 06/26/1998 OSTEOGRAF/N-700 CERAMED DENTAL, LLC. MARK BOWERMAN
K981126 06/25/1998 CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 CERAMOPTEC, INC. JONATHAN S KAHANM ESQ.
K980838 06/02/1998 REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC. JONATHAN S KAHAN
K981555 06/01/1998 DIASCREEN REAGENT STRIPS CHRONIMED, INC. VICKI FRAWLEY
K980826 06/01/1998 EQUIDOSE SOLID STATE DIODE DETECTORS CII MASTEK, INC. JORGE A FERNANDEZ
K980972 06/12/1998 RIGID CULDOSCOPE AND ACCESSORIES CIRCON CORP. RONALD J EHMSEN
K980960 06/10/1998 IN-CHECK INSPIRATORY FLOWMETER CLEMENT CLARKE INTL., LTD. M J WILKINSON
K981157 06/16/1998 STABLE FLOW CMED GREG HOLLAND
K974812 06/01/1998 COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K973936 06/01/1998 FOCUS RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K981906 06/29/1998 MODIFICATION FOR PTA BALLOON CATHETER COOK, INC. APRIL LAVENDER
K980653 06/09/1998 PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM CORDIS CORP. CHARLES J RYAN
K972881 06/04/1998 CES VASCULAR OCCLUSION SYSTEM CORDIS NEUROVASCULAR, INC. ELSA I CHI
K981202 06/16/1998 WATER FILLED GUM SOOTHER CORIUM CORP. JOSEPH HAKIM
K964514 06/26/1998 CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS CORPAK, INC. ROBERT E BOOTH
K981304 06/22/1998 NITRILON CORRECT-TOUCH CT INTL. MIKE KYLE
K981027 06/08/1998 E.CAM LSO 311 PET/SPECT SYSTEM CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K981990 06/22/1998 MRS-400, MAXI 400, MRSL-400, MAXI 400L D.B.I. AMERICA CORP. UBIRACI R FERNANDES
K981622 06/08/1998 DADE TRU-LIQUID CARDIAC CONTROL DADE BEHRING, INC. RICHARD D BLISS, JR.
K974178 06/26/1998 PASSPORT 5L-CE MODEL 0998-00-0131XXX DATASCOPE CORP. RUSSELL OLSEN
K974792 06/02/1998 CS/3(TM) MONITORS* DATEX-ENGSTROM, INC. JOEL KENT
K980362 06/30/1998 MRI COMPATIBLE MONITOR AND ACCESSORIES DATEX-ENGSTROM, INC. JOEL C KENT
K981320 06/29/1998 DAUM BONE BIOPSY SET DAUM CORP. GARY J SFEIR, RAC
K980946 06/08/1998 MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP DENTSLEEVE PTY., LTD. MARCUS TIPPETT
K981670 06/22/1998 DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DEPUY, INC. SALLY FOUST
K981167 06/18/1998 STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT DHD HEALTHCARE CORP. JEAN WALLACE
K981609 06/03/1998 BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K981872 06/29/1998 SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K981495 06/10/1998 IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K974176 06/17/1998 BABYLOG 8000 PLUS DRAGER, INC. HARALD KNEUEAR
K980779 06/26/1998 THALAFIX NATURAL SEA SALT DRESSING DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY, M.SC
K981053 06/18/1998 KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW EASTMAN KODAK COMPANY ROBERT WOLFARTH
K981769 06/29/1998 HICHEM PHOSPHORUS REAGENT KIT ELAN PHARMA, INC. WYNN STOCKING
K980170 06/29/1998 SURGITRON ELLMAN INTL., INC. FRANK LIN
K974344 06/03/1998 CT SCOPE ELSCINT, INC. STEVEN KAY
K980914 06/04/1998 EMORY CARDIAC TOOL BOX EMORY UNIVERSITY ERNEST V GARCIA
K981219 06/29/1998 OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES ENABLE MEDICAL CORP. MARK L FRIEDMAN, PHD
K965223 06/29/1998 RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM ENDOSONICS CORP. ADAM SAVAKUS
K981088 06/05/1998 MILLS COLUMELLA PROSTHESIS EXMOOR PLASTICS LTD. MARGARET BLACKEMORE
K973365 06/15/1998 AIC - CHEK (HBAIC-I) EXPRESS-MED, INC. D. ALAN SCANTLAND
K981548 06/18/1998 NFC NEEDLEFREE CONNECTOR MODEL 69900 FILTERTEK, INC. LARRY LARKIN
K981547 06/18/1998 NFC NEEDLEFREE Y-SITE, MODEL 69970 FILTERTEK, INC. LARRY LARKIN
K980728 06/19/1998 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K980979 06/12/1998 FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K981514 06/16/1998 GC FUJI BOND LC GC AMERICA, INC. TERRY L JORITZ
K981461 06/25/1998 GC FUJI ORTHO LC GC AMERICA, INC. TERRY L JORITZ
K981370 06/01/1998 MIRACLE MIX CAPSULE GC AMERICA, INC. TERRY L JORITZ
K981190 06/30/1998 HIGH IMPEDANCE CARDIAC GATING CABLE GE MEDICAL SYSTEMS LARRY KROGER
K981217 06/18/1998 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION GE MEDICAL SYSTEMS LARRY KROGER
K980959 06/04/1998 VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS F.I. HAIFA YAIR FRIEDMAN
K981422 06/10/1998 TC SERIES GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. EUGENE M NAVES
K981421 06/10/1998 TC SERIES (RECLINER) GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. EUGENE M NAVES
K981419 06/10/1998 TC SERIES (TILT RECLINER) GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. EUGENE M NAVES
K981418 06/10/1998 TC SERIES (TRANSPORT) GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. EUGENE M NAVES
K981420 06/10/1998 TC SERIES (WIDE) GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC. EUGENE M NAVES
K974583 06/09/1998 DEEGLITE GRASS-TELEFACTOR PRODUCT GROUP JAMES S BRYAN
K962959 06/05/1998 PERACIDIN DIALYZER REPROCESSING CONCENTRATE HDC MEDICAL, INC. LISA S JONES
K974879 06/29/1998 MODEL 7410 VOYAGER HEALTHDYNE TECHNOLOGIES, INC. TIMOTHY Y COWART
K981536 06/29/1998 QUANTECH MYOGLOBIN ASSAY HELLEN PROFESSIONAL SERVICES ROBIN J HELLEN
K974087 06/15/1998 MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT HEWLETT-PACKARD CO. RAY STELTING
K981265 06/23/1998 PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA HEWLETT-PACKARD CO. RENEE J THIBEAULT
K974843 06/18/1998 DURACON(R) SMALL STABILIZER TIBIAL INSERT HOWMEDICA CORP. MAGARET F CROWE
K981261 06/22/1998 HOWMEDICA SCN NAIL HOWMEDICA CORP. VIVIAN KELLY
K980843 06/02/1998 EXETER INTRAMEDULLARY BONE PLUG HOWMEDICA, INC. FRANK MASS
K980813 06/26/1998 RELIANCE LONG STEM FEMORAL COMPONENTS HOWMEDICA, INC. FRANK MAAS
K981283 06/10/1998 ROGACHEFSKY DISTAL RADIUS PLATES HOWMEDICA, INC. JOHN DICHIRA
K982071 06/29/1998 I-STAT LACTATE TEST I-STAT CORP. PAUL VANDRWERF
K981062 06/01/1998 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES IDEAL QUALITY SDN., BHD. LIM LENG BUNG
K981560 06/08/1998 IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM IMPLEX CORP. JOHN A SCHALAGO
K981193 06/16/1998 INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. STEPHEN M PAGE
K981340 06/22/1998 INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM INNOVASIVE DEVICES, INC. ERIC BANNON
K981753 06/30/1998 INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING INNOVATIVE TECHNOLOGIES LTD. CHRISTOPHER OAKES
K981330 06/19/1998 QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981328 06/19/1998 QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981237 06/05/1998 QUANTA LITE RIBOSOME P ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981166 06/22/1998 ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 INRAD ANNE ARMSTRONG
K981003 06/16/1998 ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES INTERNATIONAL MEDICAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K981398 06/01/1998 ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM INTERNEURON PHARMACEUTICALS, INC. SONJA LOAR
K974761 06/16/1998 BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH JOHN O. BUTLER CO. THOMAS J MULDOON
K973251 06/22/1998 KSEA CALCUSON KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K981233 06/15/1998 KSEA CALCUSPLIT KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K980899 06/11/1998 JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID KENSHIN TRADING CORP. KUNIO SUZUKI
K980873 06/19/1998 KONICA DIRECT DIGITIZER REGIUS MODEL 330 KONICA CORP. RUSSELL D MUNVES
K980980 06/15/1998 MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 KONIGSBERG INSTRUMENTS, INC. ARLIN HANSON
K980216 06/16/1998 KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 KREATIV, INC. JOE FOREHAND
K981667 06/05/1998 HYDROPHILIC COATED GUIDEWIRE LAKE REGION MFG., INC. KIM E AVES
K981063 06/23/1998 AUTOMATED CORNEAL TREPHINE LASER CENTER DEV. CORP. FRANCIS E O'DONNELL, JR.
K981159 06/01/1998 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES LATEXX PARTNERS BHD. GOH SEE KHEK
K981767 06/11/1998 QTEXX POWDERFREE LATEX EXAMINATION GLOVES LATEXX PARTNERS BHD. GOH S KHEK
K981269 06/24/1998 UNIVERSAL DRIVE SYSTEM LINVATEC CORP. CAROL A WEDEMAN
K980957 06/10/1998 KAPLAN-SIMPSON INFUSASLEEVE II (100) OR IS-2 (100) LOCALMED, INC. AARON KAPLAN
K980785 06/10/1998 STERILE, POWDERFREE LATEX EXAMINATION GLOVE LONDON INTL. LLC. NEIL ANDERSON
K981234 06/05/1998 FLARE,FILE, FILL LONE STAR TECHNOLOGIES EDWARD SPEHAR
K980968 06/09/1998 LONE STAR IMPRESSION SYSTEMS LONE STAR TECHNOLOGIES EDWARD SPEHAR
K981893 06/22/1998 HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES M.R.G. INDUSTRIES SDN. BHD. SEE KHEK GOH
K981416 06/24/1998 MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 MAGNA ADVANCED TECHNOLOGIES, INC. ANNIE VELEZ
K981386 06/29/1998 MANAN BLUNT NEEDLE MANAN MEDICAL PRODUCTS, INC. MICHAEL PLISHKA
K982024 06/29/1998 OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. SCOT KINGHORN
K981933 06/29/1998 URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 MEDICAL ANALYSIS SYSTEMS, INC.
K981477 06/10/1998 MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE MEDICAL BIOPSY, INC. STEPHEN M PAGE
K980904 06/08/1998 MUCHECK MONITOR UNIT VALIDATION PROGRAM MEDICAL DOSIMETRY SERVICES, INC. GREGORY MILLER
K973888 06/03/1998 SMARTLOCK SAFETY SYRINGE MEDICAL INNOVATION LTD. DANIEL A KRACOV
K981387 06/10/1998 EVANESCE SCAR MANAGEMENT SYSTEM MEDICAL SCIENTIFIC, INC. PAUL NARDELLA
K980234 06/17/1998 THE NETWORK SYSTEM MEDICAL SNI LTD. ELI M ORBACH
K981094 06/18/1998 MEDRAD NEUROVASCULAR COIL MEDRAD, INC. RODNEY J RYLANDS
K981724 06/22/1998 O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 MEDTREX, INC. WILLIAM E MCKAY
K981046 06/16/1998 MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 MEDTRONIC PS MEDICAL RICHARD M RUEDY
K980753 06/29/1998 CHROMOSCAN SCANNING SYSTEM MEHL/BIOPHILE INTL., INC. THOMAS BLAKE R.PH
K974473 06/17/1998 EASY RIDER MICRO CATHETER MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K970668 06/10/1998 THE AMPLANTZ "GOOSE NECK" MICROSNARE MICROVENA CORP. KAREN BANNICK
K981433 06/25/1998 ORTHODONTIC BRACES MIDWEST ORTHODONTIC MFG. JEFFREY L FASNACHT
K981140 06/25/1998 MINRAD DRTS LIGHT SABER SYRINGE MINRAD, INC. THOMAS L PARKER
K980948 06/25/1998 VED VALU- VACUUM ERECTION DEVICE MISSION PHARMACAL COMP ANDREW I SEALFON
K971006 06/01/1998 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) MRL DIAGNOSTICS MICHAEL J WAGNER
K971007 06/01/1998 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) MRL DIAGNOSTICS MICHAEL J WAGNER
K973096 06/12/1998 NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM NEOTONUS, INC. SHELIA HEMEON-HEYER
K981194 06/30/1998 FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT NEXA ORTHOPEDICS, INC. JAMAL D RUSHY
K980814 06/23/1998 PURESPERM NIDACON INTERNATIONAL AB DANIEL KAMM
K981447 06/05/1998 DIO-LIGHT 60 LASER SYSTEM NIDEK, INC. KEN KATO
K974292 06/08/1998 NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K980569 06/12/1998 FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS NORLAND CORP. TERRY SCHWALENBERG
K980289 06/12/1998 FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER NORLAND CORP. TERRY SCHWALENBERG
K974321 06/22/1998 HYDROTONE NORTH AMERICAN TECHNICAL SERVICES CORP. RICHARD C LANZILLOTTO
K965117 06/26/1998 LIFE SUPPORT FOR TRAUMA AND TRANSPORT NORTHROP GRUMMAN CORP. LOUIS S TOTH
K980162 06/05/1998 MACH-SIGMA HANDPIECE, ULTRAPUSH NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K981743 06/09/1998 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K982035 06/24/1998 OLYMPUS CALCIUM ARSENAZO III REAGENT OLYMPUS DIAGNOSTICA GMBH LAURA STORMS-TYLER
K981114 06/25/1998 MICROCAP ORIDION MEDICAL LTD. SANFORD BROWN
K980952 06/01/1998 SNORE-CURE ANTI-SNORING APPLIANCE ORTHO-TAIN, INC. DAVID L ROSEN
K981309 06/22/1998 OSTEO I-C HUMERAL NAIL SYSTEM OSTEONICS CORP. MARYBETH NAUGHTON
K981109 06/09/1998 QUITETIP PARADIGM MEDICAL INDUSTRIES, INC. RICHARD DIRKSON
K973864 06/17/1998 COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO PAUSCH CORP. KENNETH J H. RICE
K974880 06/08/1998 PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM PERCEPTION, INC. SUSAN D GOLDSTEIN-FALK
K981390 06/11/1998 ODONTOSURGE 2 PERIOGIENE DAVID L WEST
K981687 06/03/1998 QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 PHAMATECH CARL A MONGIOVI
K981657 06/18/1998 PHILIPS THORAVISION PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K981410 06/30/1998 HAMMERSMITH ENDOCAVITARY COILS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KELLER
K980918 06/03/1998 JPACS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K980132 06/26/1998 PHYTACARE ALGINATE HYDROGEL WOUND DRESSING PHYTATEK LABORATORIES, INC. R. ANTHONY HOWARD
K982127 06/23/1998 POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER POROUS MEDIA CORP. KEITH A ROBERTS
K981754 06/16/1998 AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 PORTER INSTRUMENT CO., INC. STEPHEN D LOEFFLER
K981015 06/16/1998 PALI-TRODE PREFERRED INSTRUMENTS CHARLES W SCOUTEN, PH.D.
K981771 06/12/1998 ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP PRINCETON BIOMEDITECH CORP. JEMO KANG
K981443 06/25/1998 BIOSIGN HCG I - ONE STEP PREGNANCY TEST PRINCETON BIOMEDITECH CORP. JEMO KANG
K981822 06/24/1998 DRS SYSTEM PROFESSIONAL DISTRIBUTION SYSTEMS, INC. DAVID WILLIAMS
K980074 06/12/1998 56 SERIES AEROSOL GENERATOR PROJECT MARKETING TERRY O'BRIEN
K980540 06/15/1998 SERAQUEST ANTI-SM QUEST INTL., INC. ROBERT A CORT
K980639 06/15/1998 SERAQUEST ANTI-SSB QUEST INTL., INC. ROBERT A CORT
K981722 06/03/1998 QUIDEL HOME PREGNANCY TEST QUIDEL CORP. E. JOSEPH MCMULLEN
K981770 06/05/1998 RAPIDHCG PREGNANCY TEST RAPID DIAGNOSTICS, INC. CHARLES YU
K982056 06/24/1998 RAICHEM CO2 REAGENT REAGENTS APPLICATIONS, INC.
K981506 06/25/1998 RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) REPRO-MED SYSTEMS, INC. ANDREW I SEALFON
K974417 06/24/1998 SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM RESMED CORP. SCOTT DUDEVOIR
K980996 06/05/1998 COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) ROCHE DIAGNOSTIC SYSTEMS, INC. JAMES W HAYNES
K981632 06/15/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH LUANN OCHS
K964153 06/11/1998 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K981203 06/05/1998 RUSCH BLAKEMORE 3 LUMEN, STERILE RUSCH INTL. JAMES R WHITNEY
K980870 06/09/1998 RUSCH SILICONE FOLEY CATHETER RUSCH, INC. JAMES R WHITNEY
K973201 06/05/1998 PROVI CEMENT S & C POLYMER GMBH JURGEN ENGELBRECHT
K981375 06/10/1998 ACE T UPTAKE REAGENT TU CALIBRATORS SCHIAPPARELLI BIOSYSTEMS, INC. STEVEN DALESSIO
K981377 06/10/1998 ACE T4 REAGENT T4 CALIBRATORS SCHIAPPARELLI BIOSYSTEMS, INC. STEVEN DALESSIO
K981124 06/04/1998 ACCUDEXA BONE DENSITOMETER SCHICK TECHNOLOGIES, INC. T. WHIT ATHEY
K982009 06/25/1998 ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE SCITECH SOLUTIONS, INC. CLIVE M DEFTY
K973914 06/30/1998 SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR SENSE TECHNOLOGY, INC.
K981496 06/15/1998 COLOR-SLIDE RF SERADYN, INC. MARTIN J WEINSTEIN
K981133 06/05/1998 POWDERED NITRILE EXAMINATION GLOVES SERVICOM SERVICES SDN BHD N.S. KUMAR
K981430 06/05/1998 UNION MEDICAL UM-D30 COAGULATOR SHE MEDICAL, INC. ANNIE VELEZ
K974914 06/03/1998 SHELHIGH NO-REACT PERICARDIAL PATCHES SHELHIGH, INC. SHLOMO GABBAY
K980882 06/05/1998 SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE E.M. EMERY
K981302 06/25/1998 SMC 28MM CERAMIC FEMORAL HEADS SIGNAL MEDICAL CORP. LOUIS A SERAFIN, JR.
K981833 06/26/1998 SILIMED NASAL "L" SHAPED IMPLANT SILIMED, LLC. E.J. SMITH
K981115 06/25/1998 RADIO-PLAST SMITH & NEPHEW, INC. CORDELL C HOFFINS
K981150 06/22/1998 SOLOSITE GEL CONFORMABLE DRESSING SMITH & NEPHEW, INC. JIM G IRVIN
K981383 06/16/1998 ALLOYBOND SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K981902 06/25/1998 SPENCO SILICONE GEL SHEET SPENCO MEDICAL CORP. BRENDA HUNT
K980829 06/02/1998 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP STERIPAK, LTD. JASON A GROSS
K980970 06/08/1998 IIRAD DIRECTRAY OPERATOR CONSOLE STERLING DIAGNOSTIC IMAGING, INC. JEAN E BARTLETT
K980100 06/01/1998 STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK STORZ INSTRUMENT CO. PATRICK G BALSMANN
K981717 06/30/1998 STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR STRYKER INSTRUMENTS NICOLE PETTY
K980494 06/09/1998 SUPERGLOVES SUPERMAX SDN BHD STANLEY THAI
K981621 06/19/1998 ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS SURETEX PROPHYLACTICS (INDIA) LTD. V V RAMANA RAO
K981448 06/16/1998 KERR HARD DENTURE RELINE MATERIAL SYBRON DENTAL SPECIALTIES, INC. WENDY A URTEL
K981075 06/22/1998 SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET SYNTHES (USA) SHERI L MUSGNUNG
K981362 06/29/1998 SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR SYNTHES (USA) SHERI L MUSGNUNG
K981275 06/25/1998 SYNTHES (USA) RATCHETING DISTRACTOR SYNTHES (USA) SHERI L MUSGNUNG
K981197 06/16/1998 ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST TCPI, INC. JACK L ARONOWITZ .
K981650 06/29/1998 AST/SGOT LIQUID REAGENT - KINETIC METHOD TECO DIAGNOSTICS RHODA FILIPINA
K981543 06/08/1998 OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K981795 06/12/1998 CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO THERMO BIOANALYSIS CORP. JANET A MCGRATH
K974595 06/24/1998 CUSHING BAYONET, INSULATED BIPOLAR FORCEP TITAN MFG., INC. DONALD SEAVEY
K974594 06/24/1998 SEMKIN BIPOLAR FORCEP TITAN MFG., INC. DONALD SEAVEY
K974593 06/24/1998 SEMKIN INSULATED BIPOLAR FORCEP TITAN MFG., INC. DONALD SEAVEY
K981080 06/17/1998 SCOOP 1 TRANSTRACHEAL SYSTEMS LESIS WARD
K981271 06/25/1998 CLEARPLAN EASY OVULATION TEST UNIPATH LTD. LOUISE ROBERTS
K981935 06/25/1998 POLYSORB SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JAMIE YIEH
K981838 06/25/1998 ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 UNOTECH DIAGNOSTICS, INC. KEN WU
K980915 06/29/1998 VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM VALLEYLAB, INC. CHARLES M COPPERBERG
K981056 06/12/1998 VARIAN XIMATRON SCAN VISION CT VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K973013 06/19/1998 OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER VAS-CATH, INC. DONNA J WILSON
K973975 06/12/1998 RESPIRTECHPRO VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K981859 06/26/1998 SURGIFLATOR-20 ECU W.O.M. WORLD OF MEDICINE, GMBH ROBERT P REZNICK
K982097 06/25/1998 WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY LAMOUREUX
K981470 06/19/1998 WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY A LAMOUREUX
K974251 06/22/1998 X-CELL WOUND DRESSING XYLOS CORPORATION ERIC FLAM
K980047 06/10/1998 URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER YEONGDONG PHARMACEUTICAL CORP. THOMAS J BOUCHARD
K981021 06/02/1998 ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981014 06/02/1998 ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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