FDA 510(k) Applications Received During May, 1998

FDA 510(k) Number Submission Date Device Name Applicant Contact
K981647 05/11/1998 3M DENT II SYSTEM 3M COMPANY LEAL PICKETT
K981570 05/04/1998 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD AARON MEDICAL INDUSTRIES ROB SARON
K981614 05/06/1998 NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL AARON MEDICAL INDUSTRIES J.ROBERT SARON
K981639 05/08/1998 SYSTEM U3 FOR CIPROFLOXACIN AB BIODISK ANNE BOLMSTROM
K981892 05/29/1998 QUICK & SURE ONESTEP HOME PREGNANCY TEST ABACUS DIAGNOSTICS PAMELA BAGARIA
K981758 05/19/1998 ALBG ABBOTT LABORATORIES MARK LITTLEFIELD
K981814 05/22/1998 ALBP ABBOTT LABORATORIES MARK LITTLEFIELD
K981806 05/21/1998 ALKP ABBOTT LABORATORIES
K981706 05/14/1998 AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 ABBOTT LABORATORIES MARK LITTLEFIELD
K981653 05/11/1998 AMY ABBOTT LABORATORIES MARK LITTLEFIELD
K981843 05/26/1998 AST ABBOTT LABORATORIES MARK LITTLEFIELD
K981578 05/04/1998 CA ABBOTT LABORATORIES MARK LITTLEFIELD
K981652 05/11/1998 CHOL ABBOTT LABORATORIES MARK LITTLEFIELD
K981840 05/26/1998 CO2 ABBOTT LABORATORIES MARK LITTLEFIELD
K981799 05/21/1998 CREA ABBOTT LABORATORIES MARK LITTLEFIELD
K981580 05/04/1998 HDL ABBOTT LABORATORIES MARK LITTLEFIELD
K981581 05/04/1998 IRON ABBOTT LABORATORIES MARK LITTLEFIELD
K981791 05/21/1998 MG ABBOTT LABORATORIES MARK LITTLEFIELD
K981759 05/19/1998 PHOS ABBOTT LABORATORIES MARK LITTLEFIELD
K981654 05/11/1998 TIBC ABBOTT LABORATORIES MARK LITTLEFIELD
K981682 05/13/1998 UPRO ABBOTT LABORATORIES MARK LITTLEFIELD
K981766 05/19/1998 URIC ACID ABBOTT LABORATORIES MARK LITTLEFIELD
K981714 05/15/1998 TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM ACROMED CORP. MARY LEWIS
K981704 05/14/1998 AUREX-3 ADM TRONICS UNLTD, INC. JAMES E LENICK
K981625 05/07/1998 STERRAD 50 STERILIZER ADVANCED STERILIZATION PRODUCTS KEVIN CORRIGAN
K981661 05/06/1998 HEMAPROMPT AERSCHER DIAGNOSTICS ROBERT SCHREIBER
K981564 05/01/1998 AIR TECHNIQUES' AIRDENT II AIR TECHNIQUES, INC. JOSEPH CAREY
K981574 05/04/1998 OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION ALCON MICHAEL PFLEGER
K981561 05/01/1998 LIQUID ENZYME ID 90133 ALCON LABORATORIES RALPH H LARSEN
K981571 05/04/1998 MONARCH IOL DELIVERY SYSTEM ALCON LABORATORIES MARTIN A KAUFMAN
K981728 05/15/1998 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 ALEXANDER MFG. CO. KEN HEIMENDINGER
K981776 05/20/1998 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X ALEXANDER MFG. CO. KEN HEIMENDINGER
K981818 05/22/1998 CONVERTORS TRILAMINATE DRAPES ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K981891 05/29/1998 AMBU TUBECHECK AMBU, INC. SANJAY H PARIKH
K981705 05/14/1998 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K981819 05/22/1998 ANGIOLAZ VES-1CAM ANGIOLAZ, INC. JOHN D PLUMADORE
K981827 05/22/1998 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM ANGIOLAZ, INC. JOHN D PLUMADORE
K981821 05/22/1998 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR ANGIOLAZ, INC. JOHN D PLUMADORE
K981782 05/20/1998 LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM ARROW INTL., INC. BRADLEY J ENEGREN
K981870 05/28/1998 VISAGE COSMETIC SURGERY SYSTEM ARTHROCARE CORP. MARK SMUTKA
K981858 05/27/1998 ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW ATLANTIS COMPONENTS, INC. ANDREW ZIEGLER
K981715 05/15/1998 DISTAL RADIUS FRACTURE FIXATION PLATE AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K981716 05/15/1998 EXTERNAL FIXATION AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K981823 05/22/1998 OPERATING ROOM TOWELS BALDUR SYSTEMS CORP. STEVE WOODY
K981792 05/21/1998 SOLUTION ADMINISTRATION SET BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K981797 05/21/1998 B-D PEN ULTRA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K981864 05/27/1998 ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 BECKMAN COULTER, INC. ELLEN M VOSS
K981638 05/08/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K981816 05/22/1998 CUE AMBULATORY VOLUMETRIC INFUSION PUMP BECTON DICKINSON CURLIN, LLC. CHARLES J WELLE
K981877 05/28/1998 NITRILE POWDERFREE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K981674 05/12/1998 POWDERED GREEN NITRILE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K981879 05/28/1998 POWDERED NITRILE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K981673 05/12/1998 POWDERFREE GREEN NITRILE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K981675 05/12/1998 POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K981878 05/28/1998 POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K981802 05/21/1998 ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 BIO-DETEK, INC. MICHAEL R DUPELLE
K981888 05/29/1998 SMOKE-EVAC BIO-MEDICAL DEVICES, INC. NICK HERBERT
K981665 05/11/1998 SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE BIO-MEDICAL SCIENCES, INC. MARK E DILLON
K981590 05/04/1998 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON BIO-RAD ELIZABETH PLATT
K981563 05/01/1998 BIOPAK MEASUREMENT SYSTEM BIO-RESEARCH ASSOCIATES, INC.
K981624 05/07/1998 FLO-THRU BIO-VASCULAR, INC. D.E. GARDNER
K981634 05/08/1998 BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS BIOCIRCUITS CORP. SHEILA J RAMERMAN
K981666 05/11/1998 2.5 MM LACTOSORB SCREWS BIOMET, INC. MARY VERSTYNEN
K981798 05/21/1998 LACTOSORB POP RIVET BIOMET, INC. JULIE K RYAN
K981752 05/18/1998 I-STAT COAGULATION CONTROL SET BIOPOOL INTL., INC. MICHAEL D BICK
K981651 05/11/1998 AB FLU OIA BIOSTAR, INC. ROGER C BRIDEN
K981824 05/22/1998 OPTICOAT T3 EIA KIT BIOTECX LABORATORIES, INC. MOHAN MEHRA
K981883 05/29/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 BOEHRINGER MANNHEIM CORP. LUANN OCHS
K981669 05/12/1998 SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K981808 05/21/1998 BREATHAID TONGUE SCRAPER BREATHAID, LLC. J. DOUGLAS NUNN, JR.
K981660 05/11/1998 BARD 8FR., 40CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS, BAR 7FR., 30CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS C.R. BARD, INC. SANDRA PERREAND
K981628 05/07/1998 BARD QUANTUM SVR MODEL NUMBER H-6440VR C.R. BARD, INC. KAREN HEFFERNAN
K981601 05/04/1998 CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K981697 05/11/1998 CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE HEART, INC. JOHN D GREENBAUM
K981846 05/26/1998 PARENCHYMAL BOLT PRESSURE MONITORING KIT CAMINO NEUROCARE, INC. JODY J FLEMING
K981556 05/01/1998 CANON X-RAY DIGITAL CAMERA CXDI-11 CANON U.S.A., INC. GLENN IMPAL
K981779 05/20/1998 CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT CANTOR & SILVER LTD. MARTIN DALSING
K981588 05/04/1998 CARESIDE TOTAL BILIRUBIN CARESIDE, INC. KENNETH B ASARCH
K981568 05/01/1998 MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 CDC TECHNOLOGIES, INC. GEORGE J WALLACE
K981746 05/18/1998 CELL ROBOTICS' LASETTE CELL ROBOTICS, INC. CONNIE WHITE
K981698 05/14/1998 ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) CHIRON CORP. NANCY A HORNBARKER
K981592 05/04/1998 ACS:CENTAUR AFP CHIRON DIAGNOSTICS CORP. THOMAS F FLYNN
K981839 05/26/1998 ACS:CENTAUR PSA2 IMMUNOASSAY CHIRON DIAGNOSTICS CORP. WILLIAM J PIGNATO
K981555 05/01/1998 DIASCREEN REAGENT STRIPS CHRONIMED, INC. VICKI FRAWLEY
K981611 05/06/1998 SNAP-N-PEEL INTRODUCERS CIRCON CORP. RONALD J EHMSEN
K981613 05/06/1998 COBE SMARXT TUBING AND CONNECTORS COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K981804 05/21/1998 XENON LIGHT SOURCE MODEL LS6000 CONTEC MEDICAL VISION, LTD. ALBERT E AUSTIN
K981589 05/04/1998 ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES CONWAY STUART MEDICAL, INC. THOMAS WEHMAN
K981886 05/29/1998 VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER COOK, INC. APRIL LAVENDER
K981709 05/04/1998 COAGULATION FACTOR V DEFICIENT PLASMA DADE BEHRING, INC. MARIO A LOWE
K981622 05/07/1998 DADE TRU-LIQUID CARDIAC CONTROL DADE BEHRING, INC. RICHARD D BLISS, JR.
K981582 05/04/1998 SURGILON, DERMALON, & OPHTHALON DAVIS & GECK, INC. VANADA JOHNSON
K981680 05/13/1998 ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS DAYTON WATER SYSTEMS CINDY HELTON
K981734 05/18/1998 VTEC-RPLA "SEIKEN" DENKA SEIKEN'S KEVIN MANGAN
K981620 05/06/1998 MTA MATERIAL II DENTSPLY INTL. JEFFERY P LEHN
K981775 05/20/1998 DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE DEPUY ACE MEDICAL CO. PAUL DONER
K981670 05/12/1998 DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DEPUY, INC. SALLY FOUST
K981609 05/05/1998 BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K981872 05/28/1998 SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K981607 05/05/1998 ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K981871 05/28/1998 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K981812 05/22/1998 EBV-VCA IGG ELISA TEST SYSTEM DIAMEDIX CORP. NORMAN JENKINS
K981831 05/22/1998 IS EBV-EA-D IGG ELISA TEST SYSTEM DIAMEDIX CORP. NORMAN JENKINS
K981829 05/22/1998 IS EBV-EBNA-1 IGG ELISA TEST SYSTEM DIAMEDIX CORP. NORMAN JENKINS
K981729 05/15/1998 IS-RUBELLA IGG TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K981867 05/28/1998 IS-VZU IGG TEST SYSTEM DIAMEDIX CORP. LYNN STIRLING
DEN980003 05/18/1998 DIAMOND PROBE/PERIO 2000 SYSTEM DIAMOND GENERAL DEVELOPMENT CORP. DALE E SEAMON
K981567 05/01/1998 HYBRID CAPTURE II CT/GC TEST DIGENE CORP. MARK A DEL VECCHIO
K981663 05/11/1998 DIGITAL DOC DIGITAL DOC LLC W. EDWARD JOHANSEN
K981881 05/28/1998 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K981718 05/15/1998 DORNIER MEDILAS H DORNIER SURGICAL PRODUCTS, INC. CAROL WERNECKE
K981773 05/20/1998 DRAGER-VAPOR 19.3 DRAEGER MEDICAL, INC. J. TERESA DORRIETY
K981769 05/19/1998 HICHEM PHOSPHORUS REAGENT KIT ELAN PHARMA, INC. WYNN STOCKING
K981790 05/20/1998 IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW ELEKTA ONCOLOGY SYSTEMS, LTD. PAUL L SUMNER
K981800 05/21/1998 SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 EQUAL DIAGNOSTICS, INC. BRENDA Y KAN
K981579 05/04/1998 ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG ETHICON, INC. GREGORY R JONES
K981813 05/22/1998 PERMACEM AUTOMIX LUTING CEMENT SYSTEM FOREMOST DENTAL MFG., INC. AN-SHIH CHENG
K981681 05/13/1998 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO HEALTHCARE WILLIAM M TOWNSEND
K981693 05/13/1998 SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 GEBAUER CO. DENISE E SPELLMAN
K981575 05/04/1998 TYMPANOSTOMY TUBE GRACE MEDICAL, INC. ANTHONY D PRESCOTT
K981856 05/27/1998 MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) GREATBATCH SCIENTIFIC GARY J SFEIR
K981619 05/06/1998 VACUETTE MULTIPLE SAMPLE LUER ADAPTER GREINER MEDITECH, INC. DOUGLAS L HARRIS
K981861 05/13/1998 LINER 1:HARD RELINE LIQUID HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K981618 05/06/1998 LIQUID A HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K981862 05/05/1998 RESIN 4 HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K981691 05/13/1998 SILICONE SOFT RELINE HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K981751 05/18/1998 SINUSCOPE AND ACCESSORIES HENKE SASS WOLF OF AMERICA, INC. ELLEN J HENKE
K981576 05/04/1998 MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A HEWLETT-PACKARD GMBH EGON PFEIL
K981794 05/21/1998 HICHEM CALCIUM REAGENT KIT HICHEM DIAGNOSTICS WYNN STOCKING
K981781 05/20/1998 ELECTROSURGICAL UNIT HILL-MED, INC. ERNESTO ACKERMAN
K981876 05/28/1998 SYNTHETIC EXAMINATION GLOVE, POWDERED HSING YI PLASTICS PROCESSING CO, LTD. JANNA P TUCKER
K981560 05/01/1998 IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM IMPLEX CORP. JOHN A SCHALAGO
K981631 05/07/1998 INFLUENCE CLIP SYSTEM INFLUENCE, INC. JONATHAN S KAHAN
K981677 05/12/1998 REPOSE BONE SCREW SYSTEM INFLUENCE, INC. JONATHAN S KAHAN, ESQ.
K981753 05/18/1998 INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING INNOVATIVE TECHNOLOGIES LTD. CHRISTOPHER OAKES
K981857 05/27/1998 QUANTA LITE TPO ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981721 05/15/1998 C0-AXIAL INTRODUCER NEEDLE INRAD ANNE ARMSTRONG
K981641 05/08/1998 MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ INSTRUMENTARIUM CORP. MAX LINDERT
K981817 05/22/1998 COAMATIC PLASMIN INHIBITOR INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K981696 05/14/1998 IL TEST PLASMIN INHIBITOR INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K981591 05/04/1998 VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT INTERNATIONAL REGULATORY CONSULTANTS DONALD F GRABARZ
K981703 05/14/1998 KSEA UNIMAT 45 KARL STORZ ENDOSCOPY KEVIN KENNAN
K981615 05/06/1998 KSEA UROPUMP KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K981737 05/18/1998 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 KATECHO, INC. LORNE S CHARNBERG
K981667 05/11/1998 HYDROPHILIC COATED GUIDEWIRE LAKE REGION MFG., INC. KIM E AVES
K981767 05/19/1998 QTEXX POWDERFREE LATEX EXAMINATION GLOVES LATEXX PARTNERS BHD. GOH S KHEK
K981755 05/18/1998 LM ANCHOR LI MEDICAL TECHNOLOGIES, INC. RHODEMANN LI
K981764 05/19/1998 LM ANCHOR LI MEDICAL TECHNOLOGIES, INC. RHODEMANN LI
K981636 05/08/1998 INTEGRATED DRIVE/PUMP SYSTEM LINVATEC CORP. CAROL A WEIDEMAN
K981637 05/08/1998 INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY LINVATEC CORP. CAROL A WEIDEMAN
K981692 05/13/1998 MENISCAL REPAIR DEVICE LINVATEC CORP. CAROL A WEIDEMAN
K981893 05/29/1998 HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES M.R.G. INDUSTRIES SDN. BHD. SEE KHEK GOH
K981772 05/19/1998 HALOLITE AAD SYSTEM MEDIC-AID LTD. PAUL E DRYDEN
K981845 05/26/1998 HAWK ANAESTHESIA INDUCTION UNIT MEDICAL INDUSTRIAL EQUIPMENT HENRY MARSHALL
K981598 05/04/1998 HERNIA MESH STABILIZER MEDIVICES CO. JOHN BELKNAP
K981724 05/15/1998 O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 MEDTREX, INC. WILLIAM E MCKAY
K981815 05/22/1998 HEPTRAC ELECTRONIC QUALITY CONTROL MEDTRONIC BLOOD MANAGEMENT JOYCE THOMAS
K981642 05/08/1998 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS MEDTRONIC CARDIORHYTHM KRISTEN HONL
K981733 05/18/1998 DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S ANN-CHRISTINE JONSSON
K981554 05/01/1998 MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) MICRA INSTRUMENTS LTD. JOHN A.K. BASKERVILLE
K981796 05/21/1998 LIGHT SABER CORE TISSUE NEEDLE MINRAD, INC. THOMAS L PARKER
K981741 05/18/1998 CARRIAZO BARRAQUER MICROKERATOME MORIA, INC. ALAIN DUPRAT
K981742 05/18/1998 ONE UP DISPOSABLE KERATOME HEAD MORIA, INC. ALAIN DUPRAT
K981837 05/26/1998 TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS MOTION CONCEPTS DAVID HARDING
K981828 05/22/1998 GALILEO DISPOSABLE HYSTEROSCOPES NETOPTIX CORP. MARY MCNAMARA-CULLINANE, RAC
K981702 05/14/1998 AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 NIHON SEIMITSU SOKKI CO., LTD. ROBERT D WAXHAM
K981730 05/15/1998 DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 NK BIOTECHNICAL CORP. KAREN GOTFREDSON
K981679 05/13/1998 TCM 3000 AND TCM ENDO NOUVAG AG MARGIT ESCHBAUMER
K981640 05/08/1998 S2LO ODYSSEY OPTICAL SYSTEMS, LLC. MAUREEN O'CONNELL
K981743 05/18/1998 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K981854 05/26/1998 OLYMPUS SERUM PROTEIN MULTICALIBRATOR, OLYMPUS DIAGNOSTICA GMBH LAURA STORMS-TYLER
K981725 05/15/1998 OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 OPTOVENT, INC. CLAES RYMOND
K981736 05/18/1998 BACT/ALERT 3D MICROBIAL DETECTION SYSTEM ORGANON TEKNIKA CORP. REBECCA A RIVAS
K981700 05/14/1998 VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM ORIGIN MEDSYSTEMS, INC. CYNTHIA G ROYSTER
K981860 05/27/1998 A P HARNESS PARAWORKS ENTERPRISE, LTD. MICHAEL C CAMPBELL
K981834 05/26/1998 PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM PERCEPTION, INC. JORGE MILLAN
K981687 05/13/1998 QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 PHAMATECH CARL A MONGIOVI
K981559 05/01/1998 UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY PHARMACIA & UPJOHN CO. KAREN E MATIS
K981930 05/01/1998 UNICAP THYROID PEROXIDASE IGG PHARMACIA & UPJOHN CO. KAREN E MATIS
K981657 05/11/1998 PHILIPS THORAVISION PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K981760 05/19/1998 PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 PLAYTIME PRODUCTS, INC. MARK ROSENGARTEN
K981865 05/28/1998 MTM BIOSCANNER K TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K981754 05/18/1998 AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 PORTER INSTRUMENT CO., INC. STEPHEN D LOEFFLER
K981805 05/21/1998 POS T-7000 POS TECHNOLOGIES, INC. MICHAEL BRODY
K981855 05/26/1998 PRINCE MEDICAL CEMENT PLUG PRINCE MEDICAL, INC. MICHAEL PRINCE
K981771 05/19/1998 ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP PRINCETON BIOMEDITECH CORP. JEMO KANG
K981801 05/21/1998 ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA PRINCETON BIOMEDITECH CORP. JEMO KANG
K981882 05/28/1998 CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST PRINCETON BIOMEDITECH CORP. JEMO KANG
K981869 05/28/1998 PRO-FLEX DISPOSABLE PROPHY ANGLE PROFESSIONAL DENTAL MFG., INC. BOB ZAHRADNIK
K981822 05/22/1998 DRS SYSTEM PROFESSIONAL DISTRIBUTION SYSTEMS, INC. DAVID WILLIAMS
K981774 05/20/1998 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE PWA INDUSTRIES SDN. BHD. AZMAN ISMAIL
K981722 05/15/1998 QUIDEL HOME PREGNANCY TEST QUIDEL CORP. E. JOSEPH MCMULLEN
K981643 05/08/1998 RTM DVT PROSOFT CUFF MODEL NUMBER PS100 R.T. MEDICAL SERVICES, INC. KAREN L DIEHL
K981820 05/22/1998 NEUROMAP RADIONICS, INC. JEFFREY R MANNION
K981597 05/04/1998 RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY RADIONICS, INC. LISA MISTERKA BENATI
K981672 05/12/1998 RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR RADIOTHERAPEUTICS CORP. COLIN J NICHOLS
K981770 05/19/1998 RAPIDHCG PREGNANCY TEST RAPID DIAGNOSTICS, INC. CHARLES YU
K981720 05/05/1998 IQ SYSTEM RENAISSANCE TECHNOLOGY, INC. PHILIP E HAMSKI
K981841 05/26/1998 BREATHE EASY, MODELS AD AND CD RESPIRAID LTD. SHOSHANA FRIEDMAN
K981558 05/01/1998 MYCYCLE HANDMASTER, LIGHT RICHVALE LTD. SUSAN MAYS
K981557 05/01/1998 MYCYCLE, HANDMASTER, VICTORY RICHVALE LTD. SUSAN MAYS
K981844 05/26/1998 SLEEP MANAGEMENT SYSTEM RMP, INC. TERRY G MAHN
K981584 05/04/1998 ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K981585 05/04/1998 ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K981632 05/08/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH LUANN OCHS
K981612 05/06/1998 ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER ROCHESTER MEDICAL CORP. MARY WILEN
K981678 05/12/1998 STRATA, MODEL V.O.95 ROSSES MEDICAL SYSTEMS RENE SPECTOR
K981629 05/07/1998 NUTRISAFE ENTERAL FEEDING TUBE SCHIFF & CO. ANNE M CESARIO
K981630 05/07/1998 VYGON DOUBLE LUMEN UMBILICAL CATHETER SCHIFF & CO. ANNE M CESARIO
K981788 05/20/1998 SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER SCIMED LIFE SYSTEMS, INC. MELANIE RASKA
K981756 05/18/1998 SHELHIGH NO-REACT PNEUMOPLEDGETS SHELHIGH, INC. SHLOMO GABBAY
K981807 05/21/1998 CARDIOVISION SOFTWARE, MODEL S-CV5-96 SHL TELEMEDICINE INTERNATIONAL LTD. ALROY YARIV
K981626 05/07/1998 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. STEVE HESLER
K981850 05/26/1998 SILIMED CHIN IMPLANTS SILIMED, LLC. E.J. SMITH
K981835 05/26/1998 SILIMED MALAR IMPLANT SILIMED, LLC. E.J. SMITH
K981833 05/26/1998 SILIMED NASAL "L" SHAPED IMPLANT SILIMED, LLC. E.J. SMITH
K981851 05/26/1998 SILIMED SILICONE CARVING BLOCK SILIMED, LLC. E.J. SMITH
K981852 05/26/1998 SILIMED TISSUE EXPANDER SILIMED, LLC. E.J. SMITH
K981847 05/26/1998 BIOLOX ALUMINA CERAMIC FEMORAL HEAD SMITH & NEPHEW, INC. JOANN KUHNE
K981713 05/15/1998 CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 SMITH & NEPHEW, INC. JIM G IRVIN
K981676 05/12/1998 CD HORIZON SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K981655 05/11/1998 SPACELABS MEDICAL DISPOSABLE SP02 SENSOR SPACELABS MEDICAL, INC. NANCY GERTLAR
K981717 05/15/1998 STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR STRYKER INSTRUMENTS NICOLE PETTY
K981562 05/01/1998 SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT SULZER CALCITEK, INC. FOSTER BOOP
K981602 05/05/1998 DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR SUNRISE MEDICAL HHG, INC. ALLAN R JONES
K981885 05/29/1998 SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE SUNRISE MEDICAL, INC. REBECCA ANDERSEN
K981747 05/18/1998 BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX SUNSCOPE INTL., INC. JOHN SHULZE
K981745 05/18/1998 BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX SUNSCOPE INTL., INC. JOHN SHULZE
K981621 05/06/1998 ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS SURETEX PROPHYLACTICS (INDIA) LTD. V V RAMANA RAO
K981686 05/13/1998 STEALTHSTATION SYSTEM DIGITIZER CHANGE SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER WHITE
K981684 05/13/1998 STEALTHSTATION TREATMENT GUIDANCE PLATFORM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K981768 05/19/1998 STEALTHSTATION TREATMENT GUIDANCE PLATFORM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K981809 05/21/1998 CAROLINE GUIDE SURGICAL SOLUTIONS, INC. MATTHEW A HOWARD, III
K981757 05/19/1998 SYNTHES (USA) DHS HELIX SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K981890 05/29/1998 SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES SYNTHES (USA) SHERI L MUSGNUNG
K981761 05/19/1998 SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER SYSMEX CORP. NINA GAMPERLING
K981650 05/11/1998 AST/SGOT LIQUID REAGENT - KINETIC METHOD TECO DIAGNOSTICS RHODA FILIPINA
K981688 05/11/1998 ANSPACH SUTURE ANCHOR THE ANSPACH EFFORT, INC. WILLIAM E ANSPACH, III
K981644 05/08/1998 BINDAZYME ANTIGLIADIN IGG THE BINDING SITE, LTD. JAY H GELLER
K981929 05/08/1998 BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT THE BINDING SITE, LTD. JAY GELLER
K981783 05/20/1998 C3 MININEPH ANTISERUM THE BINDING SITE, LTD. JAY H GELLER
K981785 05/20/1998 C4 MININEPH ANTISERUM THE BINDING SITE, LTD. JAY H GELLER
K981786 05/20/1998 IGA MININEPH ANTISERUM THE BINDING SITE, LTD. JAY H GELLER
K981784 05/20/1998 IGM MININEPH ANTISERUM THE BINDING SITE, LTD. JAY H GELLER
K981795 05/21/1998 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
K981596 05/04/1998 ULTRAPAK E ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K981573 05/04/1998 UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE UNITED BIOTECH, INC. SHARON SUN
K981838 05/26/1998 ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 UNOTECH DIAGNOSTICS, INC. KEN WU
K982229 05/15/1998 BI-DENT VALLEY FORGE SCIENTIFIC CORP. THOMAS J GILLOWAY
K981683 05/13/1998 HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y VENUSA LTD. NEIL KULKARNI
K981668 05/11/1998 SMARTVENT 201 PORTABLE VENTILATOR VERSAMED LTD. SHOSHANA FRIEDMAN
K981645 05/08/1998 TITANIUM HEMOSTATIC CLIP VITALITEC INT'L., INC. ELLEN HENKE-KNUPP
K981726 05/15/1998 PERCUSSIVETECH HF, MODEL 2001 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K981744 05/18/1998 COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER W. KEITH THORNTON, D.D.S. W.KEITH THORNTON
K981859 05/27/1998 SURGIFLATOR-20 ECU W.O.M. WORLD OF MEDICINE, GMBH ROBERT P REZNICK
K981565 05/01/1998 BIOCLEAR CONCENTRATE WAGGONER PRODUCT DEVELOPMENT MARK WAGGONER
K981853 05/26/1998 BONE INJECTION GUN (B.I.G.) DEVICE WAISMED LTD. AHAVA STEIN
K981789 05/20/1998 LORENZ PECTUS SUPPORT BAR STABILIZER WALTER LORENZ SURGICAL, INC. DIANE PRESTON
K981748 05/18/1998 WIELISA ANCA SCREENING KIT TEST SYSTEM WIESLAB AB WILLIAM L BOTELER, JR.
K981750 05/18/1998 WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM WIESLAB AB WILLIAM L BOTELER JR.
K981553 05/01/1998 AUTOMATED MEDICAL REPORT WRITER WOODSON AND ASSOCIATES, LLC. GRATTAN WOODSON, III
K981889 05/29/1998 WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY A LAMOUREUX
K981880 05/28/1998 DX-480, ADD ON DIGITAL IMAGER WUESTEC MEDICAL, INC. DAVID ANDRESS
K981627 05/07/1998 PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) XINTEC CORPORATION MARILYN M CHOU
K981600 05/04/1998 LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED YOUNG INNOVATIONS LLC DBA PLAK SMACKER JOHN A TAPOCIK


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