FDA 510(k) Decisions During May, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K000968 05/03/2000 3181 DUO DELIVERY SYSTEM A-DEC, INC. LOVENA STANDRIDGE
K000966 05/03/2000 4631 DUO DELIVERY SYSTEM A-DEC, INC. LOVENA STANDRIDGE
K000967 05/03/2000 4635 ASSISTANT'S INSTRUMENTATION A-DEC, INC. LOVENA STANDRIDGE
K992592 05/04/2000 A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 A-MED SYSTEMS, INC. ROBERTA THOMPSON
K000596 05/22/2000 ETEST GATIFLOXACIN AB BIODISK ANNE BOLMSTROM
K000298 05/18/2000 ETEST MOXIFLOXACIN AB BIODISK ANNE BOLMSTROM
K994433 05/05/2000 CONNECT DATA MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. EVE A CONNER
K992085 05/25/2000 ABBOTT IMX GLYCATED HEMOGLOBIN II ABBOTT LABORATORIES KATHERINE M WORTLEY
K991103 05/31/2000 MODIFICATION TO ACIST CL 100H ACIST MEDICAL SYSTEMS CARL M BEAURLINE
K000932 05/17/2000 ARACHNOPHLEBECTOMY NEEDLE ADVANCED MEDICAL PRODUCTS, INC. CHARLES H KYPER
K001381 05/17/2000 CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K000547 05/03/2000 ATR TECNIKA ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. DANIELE POLI
K000775 05/17/2000 HEART 2005 AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K001330 05/30/2000 SOVEREIGN BIPOLAR INSTRUMENTS AESCULAP, INC. LIA S JONES
K001308 05/17/2000 MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW AGILENT TECHNOLOGIES GRETEL LUMLEY
K001333 05/17/2000 AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI AGILENT TECHNOLOGIES DEUTSCHLAND GMBH EGON PFEIL
K994188 05/19/2000 MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 AGILENT TECHNOLOGIES, GMBH HERBERT VAN DYK
K001057 05/03/2000 AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K001348 05/17/2000 ST/AR ST AND ARRHYTHMIA SOFTWARE AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K001013 05/16/2000 MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY AIRSEP CORP. PETER WEISENBORN
K000162 05/12/2000 METRISCAN BONE DENSITY SYSTEM ALARA, INC. DIANE M KING
K000637 05/19/2000 CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) ALCON LABORATORIES, INC. S.K. MCGARVEY
K001321 05/16/2000 ALL-PRO 2010 ALL-PRO IMAGING CORP. JOSEPH CAREY
K001141 05/09/2000 POWDER FREE STERILE LATEX EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K993278 05/17/2000 AMBU NEONATE SILICONE RESUSCITATOR AMBU, INC. SANJAY PARIKH
K994362 05/11/2000 HEADLAMP HL2000. ANGIOLAZ, INC. ROBERT ALLMAN
K001239 05/15/2000 ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) ANSELL PERRY JAMES R CHATTERTON
K000545 05/02/2000 SENTRY EXPANDING INTRODUCER SHEATH (EIS) APPLIED MEDICAL RESOURCES ANIL BHALANI
K001079 05/01/2000 RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO ARJO, INC. DAVID INSCO
K001212 05/09/2000 TROJAN EXTRA LARGE LATEX CONDOM ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K000729 05/19/2000 ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL ARROW INTL., INC. WILLIAM PAQUIN
K000506 05/01/2000 BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B ARTHREX, INC. VERNON BROWN
K001302 05/30/2000 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C ARTHROCARE CORP. BRUCE PROTHRO
K000778 05/03/2000 ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 ARTHROCARE CORP. BRUCE PROTHRO
K993592 05/17/2000 AXIOM MULTIPURPOSE WOUND DRAIN AXIOM MEDICAL, INC. RIDWAN HARDY
K000960 05/26/2000 BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 BARZELL-WHITMORE MAROON BELLS, INC. ART WARD
K993816 05/04/2000 BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD BAXTER EDWARDS DIANE PETERSON
K000903 05/18/2000 ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM BAYER CORP. FREDRICK CLERIE
K000921 05/18/2000 BAYER ADVIA IMS SYSTEM; 200 + 3 BAYER CORP. FREDRICK CLERIE
K000897 05/05/2000 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE BD BIOSCIENCES CINDY MORROW
K000611 05/18/2000 STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER BD BIOSCIENCES JO-ANN E FABILA
K000121 05/17/2000 IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB BECKMAN COULTER, INC. ANNETTE HELLIE
K000606 05/05/2000 SYNCHRON SYSTEMS AMPHETAMINE REAGENT BECKMAN COULTER, INC. LUCINDA STOCKERT
K000799 05/17/2000 BELMONT UNIT, MODEL 2000 SERIES BELMONT EQUIPMENT CORP. JOHN E COLLINS
K000108 05/23/2000 RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 BHK HOLDING ART WARD
K001373 05/25/2000 LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 BIO-RAD ELIZABETH PLATT
K993319 05/22/2000 VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 BIOMERIEUX, INC. ANNA DEMARINIS
K993438 05/18/2000 METAL ON METAL ACETABULAR SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K000760 05/23/2000 REACH FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K000248 05/05/2000 CARTO EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. AMY WALTERS
K000190 05/05/2000 MODIFICATION TO CARTO EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. SIGI CARON
K000332 05/04/2000 NOGA CARDIAC NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. AMY WALTERS
K001139 05/10/2000 PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M BIOSENSE WEBSTER, INC. MARY ADAMS
K000681 05/03/2000 AU5, AU6 BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K000438 05/03/2000 MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER BIOSURGICAL CORP. TERRY LAAS
K000633 05/25/2000 SYNTHETIC GLASS BONE GRAFT MATERIAL BLUE SKY BIO RITA GIEBEL
K000510 05/15/2000 ART-M1, MODEL M1-1-ART-A1 BONART CO. LTD. BANKSON TSAI
K992320 05/18/2000 MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BOSTON SCIENTIFIC CORP. RONALD W BENNETT
K000308 05/19/2000 WALLSTENT BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K000281 05/12/2000 WALLSTENT ENTERNAL PROSTHESIS BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K001083 05/03/2000 GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K000520 05/16/2000 C-IT BREGAS AB PAUL KRILL
K000519 05/01/2000 GLUCANPRO BRENNEN MEDICAL, INC. PHIL LAWIN
K000518 05/01/2000 MACROPRO GEL BRENNEN MEDICAL, INC. PHIL LAWIN
K000639 05/25/2000 VISIONARY 2000 BURTON MEDICAL PRODUCTS CORP. DORIAN SWARTZ
K994260 05/26/2000 CANDELA GENTLELASE GL DERMATOLOGICAL LASER CANDELA CORP. JAY CAPLAN
K000609 05/23/2000 CARDTEL, MODEL NT-100 CARDIAC TELECOMMUNICATIONS J. HARVEY KNAUSS
K001100 05/05/2000 BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH CARDIODYNAMICS INTERNATIONAL CORP. BRIAN PARK
K001368 05/12/2000 PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER CARMEL PHARMA AB. KJELL ANDREASSON
K000686 05/25/2000 KROM-ALGINATE AND ALGINATE PLUS CAVEX HOLLAND B.V. RICHARD WOORTMAN
K000770 05/16/2000 PROVIEW MEDICAL IMAGE DISPLAY MODULE CERNER CORP. SHELLEY LOOBY
K000607 05/15/2000 SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K000368 05/04/2000 EYECAP IMAGING SYSTEM CLEMENT CLARKE INTL., LTD. M.J. WILKINSON
K001042 05/23/2000 COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHEE YONG FOO
K001090 05/19/2000 METHAFILCON A COOPERVISION, INC. BONNIE TSYMBAL
K001089 05/19/2000 POLYMACON COOPERVISION, INC. BONNIE TSYMBAL
K000579 05/03/2000 TEMPO AQUA ANGIOGRAPHIC CATHETER CORDIS CORP. ARIEL MACTAVISH
K000500 05/26/2000 DINAMAP ADVANCED NIBP MODULE CRITIKON COMPANY, L.L.C. THOMAS J ENGLISH
K000973 05/26/2000 BEHRING COAGULATION SYSTEM (BCS) DADE BEHRING, INC. REBECCA S AYASH
K001256 05/24/2000 CONTROL PLASMA N DADE BEHRING, INC. DONNA A WOLF
K001145 05/11/2000 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 DADE BEHRING, INC. RADAMES RIESGO
K994334 05/15/2000 ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX DAIG CORP. TODD KORNMANN
K001198 05/12/2000 DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET DATASCOPE CORP. JOANN WOLF
K000706 05/11/2000 DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR DATEX-OHMEDA, INC. DANIEL KOSEDNAR
K000894 05/19/2000 C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO DENTAL VENTURES OF AMERICA, INC. ANTHONY SIRAGUSA
K000658 05/11/2000 ERS RADIAL HEAD REPLACEMENT DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K001451 05/18/2000 MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K001086 05/18/2000 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K000982 05/01/2000 A100 AESTHETIC DIODE LASER DIOMED, INC. MAUREEN O'CONNELL
K000704 05/19/2000 DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) DMC MEDICAL LTD. CHARMAINE HENDERSON
K001243 05/24/2000 DORNIER MEDILAS H DORNIER SURGICAL PRODUCTS, INC. JOE D BROWN
K001030 05/11/2000 RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S DYMEDIX, INC. GARY SYRING
K001263 05/05/2000 SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 E S C SHARPLAN ZVI LADIN
K001264 05/30/2000 EAGLE ENDO SPECIMEN RETRIEVAL BAG EAGLE ENDOSCOPIC, INC. JOHN MAYALL
K001358 05/23/2000 EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM EBI, L.P. PATRICIA FLOOD
K000556 05/17/2000 ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS ELAN DIAGNOSTICS WYNN STOCKING
K000958 05/24/2000 ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOKING
K000900 05/02/2000 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOCKING
K000480 05/02/2000 ACTIVE ELECTRODE MONITORING SYSTEM ELECTROSCOPE, INC. LYNNE ARONSON
K001253 05/26/2000 SURGITRON IEC II ELLMAN INTL., INC. FRANK LIN
K993841 05/04/2000 CEMSTOP CEMENT RESTRICTOR ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K000521 05/10/2000 KEYSTONE HIP ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K000590 05/11/2000 LATERAL PIVOT INSERT ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K001024 05/23/2000 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. DE LOS SANTOS
K000215 05/26/2000 SWIVEL ELBOW ENGINEERED MEDICAL SYSTEMS BONNIE HOLLY
K993010 05/30/2000 BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP. HOWARD M HOLSTEIN
K001220 05/16/2000 ENDOPATH SURESEAL REDUCER CAP ETHICON ENDO-SURGERY, INC. TAMIMA ITANI
K001122 05/23/2000 PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH ETHICON, INC. GREGORY R JONES
K994098 05/23/2000 VINYL PATIENT EXAMINATION GLOVES-POWDER FREE EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. DOREEN FENG
K001335 05/18/2000 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED EXACTECH, INC. LISA SIMPSON
K991293 05/05/2000 EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR FISCHER MEDICAL TECHNOLOGIES, INC. RONALD SHORES
K001232 05/15/2000 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K000896 05/03/2000 POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K000451 05/09/2000 FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K000802 05/26/2000 SPIRAL IMAGING OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K000395 05/03/2000 EINSTEIN PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS F.I. HAIFA DAN LAOR
K001267 05/12/2000 GE SYSTEM FIVE GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K001029 05/23/2000 GEIGER NEEDLE ADAPTER, MODEL 406 GEIGER MEDICAL TECHNOLOGIES, INC. JOHN BOTTJER
K000779 05/18/2000 APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K000645 05/24/2000 GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN IAN MCDONALD
K000263 05/09/2000 GO MEDICAL BALLOON INFUSION SYSTEM GO MEDICAL INDUSTRIES PTY. LTD. GEORGE O'NEIL
K993732 05/15/2000 BVBLUE GRYPHUS DIAGNOSTICS, L.L.C. THOMAS M TSAKERIS
K001222 05/17/2000 OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 GUIDANT CORP. MARGARET ANDERSON
K001224 05/17/2000 RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 GUIDANT CORP. MARGARET ANDERSON
K001049 05/23/2000 GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K993678 05/05/2000 THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES HAEMOSCOPE CORP. ELI COHEN
K000380 05/03/2000 FOTOMASTER HAMILTON THORNE RESEARCH MEG D HAMILTON
K993760 05/15/2000 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS HARTALEGA SDN BHD KUAN KAM HON
K000303 05/16/2000 HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB HEALTHCARE SERVICE AND SUPPLY RICK ROEDER
K994243 05/05/2000 DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP HEARTPORT, INC. MARIANNE C DRENNAN
K992543 05/18/2000 HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE HEWLETT-PACKARD CO. TERESA SKARR
K993991 05/30/2000 HM-930 ELECTROSURGICAL UNIT HILL-MED, INC. JHOANA VASQUEZ
K000630 05/12/2000 MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM HOPKINS IMAGING SYSTEMS, INC. RICHARD HOPKINS
K000957 05/23/2000 HOFFMANN II EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K000965 05/11/2000 MULTI-AXIAL CROSS (MAC) CONNECTOR HOWMEDICA OSTEONICS CORP. TERRY SHERIDAN POWELL
K000636 05/11/2000 STRYKER TRAUMA PLATING SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001272 05/11/2000 XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001319 05/23/2000 XIA SPINE SYSTEM HOOKS HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K993355 05/24/2000 HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 HUDSON RESPIRATORY CARE, INC. CHARLES MIERKIEWICZ
K000915 05/12/2000 PASTEUR PIPET - STERILE 9", PASTEUR PIPET - STERILE 5 3/4", MODELS 16-PP-9, 16-PP-5.75 HUMAGEN FERTILITY DIAGNOSTICS, INC. CINDY SHOWALTER
K000472 05/10/2000 POSI-LINK ICU MEDICAL, INC. SALVADORE F PALOMARES
K001248 05/04/2000 MULTI-PULSE 2000 IMAGING SCIENCES INTL., INC. ROBERT E HAY
K001307 05/23/2000 CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ IMPLEX CORP. JOHN SCHALAGO
K992668 05/26/2000 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) INNERDYNE, INC. RICK GAYKOWSKI
K000485 05/12/2000 HYDRO2, HS-75 INNOVISION, INC. DON M WOODFORD
K001171 05/12/2000 DELTA 16 TACT INSTRUMENTARIUM IMAGING, INC. MAX LINDERT
K000405 05/17/2000 INTERCURE LTD. RESPI-LOW INTERCURE LTD. JONATHAN S KAHAN
K001257 05/18/2000 INTRACOIL STENT INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K984231 05/31/2000 ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B INVASATEC KATE ANDERSON
K000939 05/04/2000 HTF-HEPES INVITROCARE, INC. ROBERT E LOVINS
K000940 05/04/2000 HUMAN SERUM ALBUMIN (HSA) INVITROCARE, INC. ROBERT E LOVINS
K000938 05/25/2000 IVC ONE MEDIUM INVITROCARE, INC. ROBERT E LOVINS
K000937 05/25/2000 IVC TWO MEDIUM INVITROCARE, INC. ROBERT E LOVINS
K993484 05/25/2000 Q-HTF, CAT# 2001 INVITROCARE, INC. ROBERT E LOVINS
K980672 05/04/2000 SIMPLEX AIRBRATOR (SAB-7) IRT MANAGEMENT CORP. NICHOLAS G LEVANDOSKI, PH.D.
K000587 05/04/2000 SHUTTLE STOP ISOTIS NV CYNTHIA J.M. NOLTE
K000078 05/15/2000 JETLITE 4000 J. MORITA USA, INC. KEITH A BARRITT
K001260 05/17/2000 ALLROUND 55 LF J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K001196 05/11/2000 JEL BIOS 90 (CODE NAME RD-2401) J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K000738 05/26/2000 WHEELCHAIR, MODELS H001A, 4422 JACKSON COMPANY LLC. DEBORAH WEIMAN
K000805 05/04/2000 KAVO K.E.Y. LASER 1242 KAVO AMERICA JOHN FRANZ
K001043 05/19/2000 KAWASUMI LABORATORY BLOOD DRAWING KIT KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K000948 05/12/2000 OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. ROGER GRAY
K990614 05/23/2000 HME-BOOSTER KING SYSTEMS CORP. CHARLES A BURT
K001190 05/23/2000 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM KWAN HWA
K000320 05/02/2000 SONOS AIRES 600 (SA-600) KPI ULTRASOUND, LLC. STEVEN S MINN
K000663 05/02/2000 KRONNER LOW PROFILE SCOPE HOLDER KRONNER PROTOTYPES, INC. RICHARD KRONNER
K000950 05/12/2000 EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 LABOTECT LABOR-TECHNIK GOTTINGEN ANGELIKA ALBRECHT
K001144 05/05/2000 ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS LASERSIGHT TECHNOLOGIES, INC. SAM MIRZA
K001428 05/26/2000 OPTIMUM WETTING AND REWETTING DROP LOBOB LABORATORIES, INC. DANIEL J MANELLI
K001115 05/17/2000 ULTRA CATHETER SET LYCO ENTERPRISES, INC. ROBERT L CHILD
K000503 05/15/2000 MEDART 520 COOLING SYSTEM MEDART CORP. JAN K ENEMAERKE
K993815 05/11/2000 UNI-LASER 430 MEDART CORP. JAN K ENEMAERKE
K000328 05/09/2000 MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP MEDEX, INC. CATHY CHENETSKI
K000926 05/15/2000 EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER MEDICA CORP. PHOTIOS MAKRIS
K993758 05/19/2000 PROAIR 3000 COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. SHOSHANA FRIEDMAN
K000693 05/16/2000 UMECO OPTIMA MULTILINE LASER SYSTEM MEDICAL LASER SOLUTIONS LLC. IAIN D MILLER
K991471 05/09/2000 MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) MEDICULT A/S RONALD G LEONARDI
K991472 05/09/2000 MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 MEDICULT A/S RONALD G LEONARDI
K991327 05/04/2000 MEDI-CULT FLUSHING MEDIUM MEDICULT A/S RONALD G LEONARDI
K991332 05/04/2000 MEDI-CULT SPERM PREPARATION - MEDIUM; MEDICULT A/S RONALD G LEONARDI
K001293 05/05/2000 MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE MEDIMOP MEDICAL PROJECTS, LTD. BRUCE F MACKLER
K000669 05/26/2000 MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY MEDIVISION ENDOSCOPY WAYNE B STERNER
K000386 05/05/2000 POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K001153 05/03/2000 MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM MEDTRONIC SURGICAL NAVIGATION VICTORIA RENDON
K000233 05/19/2000 MENICON SF-P MENICON CO. LTD. BEVERLEY D VENUTI
K000133 05/19/2000 MENICON Z MENICON U.S.A., INC. BEVERLY D VENUTI
K000563 05/17/2000 MODIFICATION TO ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. KENNETH RAICHMAN
K001237 05/18/2000 EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K994380 05/02/2000 CEDIA DAU AMPHASSURE ASSAY MICROGENICS CORP. NEAL BELLET
K993699 05/16/2000 THE STRIPPER MID-ATLANTIC DIAGNOSTICS, INC. TERRANCE J FORTINO
K000680 05/25/2000 VISION ESTHETIC PORCELAIN SYSTEM MIDATLANTIC DIVISION OF DENTREX, INC. LAURANCE W POWELL
K000690 05/17/2000 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE MINNESOTA MINING AND MFG. CO. LINDA JOHNSON
K000999 05/22/2000 MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MULTISAFE SDN BHD ABD. HADI BIN HUSIN
K992178 05/12/2000 BALLOON FOR ULTRASONIC ENDOSCOPES N.M. BEALE CO. INC. NATHANIEL M BEALE
K000604 05/23/2000 NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT NATUROPATHIC LABORATORIES INTERNATIONAL, INC. EMALEE G MURPHY
K993921 05/23/2000 NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 NDD MEDICAL TECHNOLOGIES OSCAR KAELIN
K993877 05/25/2000 NELSON WATER SYSTEMS FOR HEMODIALYSIS NELSON ENVIRONMENTAL TECHNOLOGIES, INC. BURKE A WEST
K000812 05/17/2000 NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) NEUROSOFT, INC. DAVID B JONES
K994140 05/09/2000 NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K001085 05/01/2000 MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 NONIN MEDICAL, INC. RICHARD P BENNETT
K993337 05/16/2000 APOLLO MULTI-RACIAL REFERENCE POPULATION NORLAND MEDICAL SYSTEMS, INC. TERRY SCHWALENBERG
K000710 05/11/2000 MD 10, SEM, SM 12, CBM NOUVAG AG MARGIT ESCHBAUMER
K001339 05/17/2000 MRI FASTSYSTEM RETRACTOR SYSTEM OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. CATHERINE MILLER
K001169 05/16/2000 OPTIVU HDVD SYSTEM OPTIMIZE, INC. KEN GONG
K001197 05/11/2000 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K000399 05/15/2000 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 ORASURE TECHNOLOGIES, INC. R. SAM NEIDBALA
K000691 05/04/2000 VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS ORATEC INTERVENTIONS, INC. JENNIFER BRENNAN
K001310 05/05/2000 VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A SHULMAN
K001266 05/02/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE PHILLIPS
K000930 05/22/2000 GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K000928 05/15/2000 QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K994225 05/18/2000 PALOMAR SLP 2000 PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K993586 05/22/2000 SPORTSIGHT GP PARAGON VISION SCIENCES WILLIAM E MEYERS
K000694 05/11/2000 PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) PECTOFIX, INC. ERIC BANNON
K001397 05/26/2000 QUICKSCREEN PRO DRUG CUP, MODEL 9195X PHAMATECH CARL MONGIOVI
K000819 05/12/2000 PHILIPS CT SECURA MV PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FRANK GIANELLI
K000514 05/10/2000 RUMBAR DRAINAGE SYSTEM PHOENIX BIOMEDICAL CORP. COURTNEY SMITH
K001055 05/11/2000 MODEL 4300 PSARRAY EEG ELECTRODE SET PHYSIOMETRIX, INC. DAWN E FRAZER
K000734 05/05/2000 PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 PIONEER SURGICAL TECHNOLOGY AMY MOMMAERTS
K000771 05/03/2000 DIMAX 2 PLANMECA OY BOB PIENKOWSKI
K001221 05/19/2000 MALE LATEX COMDOM WITH DOTTED SURFACE PLEASURE LATEX PRODUCTS SDN. BHD. KOI-YONG LIM
K994126 05/04/2000 MODULAR-PLUS REVISION STEM PLUS ORTHOPEDICS HARTMUT LOCH
K000795 05/26/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY DEBRA L.B. KETCHUM
K991894 05/24/2000 BIOSCANNER TRIGLYCERIDES TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K001327 05/23/2000 POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) PREMIER PATHWAY SDN. BHD. JANNA P TUCKER
K001108 05/30/2000 PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL PRIME DENTAL MANUFACTURING, INC. ROLANDDO MARASIGAN
K993131 05/22/2000 NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY PRIMUS, INC. JIMMIE K NOFFSINGER
K001225 05/17/2000 ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. PRINCETON BIOMEDITECH CORP. JEMO KANG
K001098 05/18/2000 PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 PRO. DUCT HEALTH, INC. ANGELA B SOITO
K001132 05/01/2000 BONE BIOPSY NEEDLE PROMEX, INC. JOSEPH L MARK
K000216 05/09/2000 PSK ENDOSCOPE CLEANING SYSTEM PSK CONNECTORS PTY LTD BRIAN NEWTON
K994426 05/23/2000 GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) PT. WRP BUANA MULTICORPORA NG POY SIN
K991886 05/11/2000 PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR PULSION MEDICAL SYSTEMS, INC. ULF BORG
K994274 05/31/2000 QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) QUEST MEDICAL, INC. MALCOLM LEWIS
K993777 05/25/2000 DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES R-GROUP INTL. KERRY A KAHN
K001431 05/17/2000 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. KEVIN J O'CONNELL
K000783 05/04/2000 DIRECT TIBC CALIBRATOR REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K000781 05/02/2000 DIRECT TIBC KIT REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K001208 05/12/2000 ESPIRT RESPIRONICS, INC. KATHY MOORE
K000420 05/08/2000 SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 RETINALABS.COM FRANK TIGHE
K000416 05/08/2000 TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 RETINALABS.COM FRANK TIGHE
K000457 05/09/2000 VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES RETINALABS.COM FRANK TIGHE
K000752 05/09/2000 RHIGENE MESACUP2 TEST- RNP RHIGENE, INC. DAVE KOLESAR
K000750 05/09/2000 RHIGENE MESACUP2 TEST- SCL-70 RHIGENE, INC. DAVE KOLESAR
K000755 05/09/2000 RHIGENE MESACUP2 TEST- SM RHIGENE, INC. DAVE KOLESAR
K000749 05/09/2000 RHIGENE MESACUP2 TEST- SSA RHIGENE, INC. DAVE KOLESAR
K000751 05/09/2000 RHIGENE MESACUP2 TEST- SSB RHIGENE, INC. DAVE KOLESAR
K000673 05/26/2000 HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K000905 05/12/2000 URETHROTOME 8667.XXX AND 8670.XXX RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K000155 05/17/2000 ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K000784 05/18/2000 THE CARDIAC READER SYSTEM ROCHE DIAGNOSTICS CORP. SUSAN D GOLDSTEIN-FALK
K000723 05/19/2000 HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) ROCHESTER MEDICAL CORP. MARY WILEN
K001119 05/19/2000 ROVERS ENDOCERVEX-BRUSH ROVERS MEDICAL DEVICES B.V. TODD M GATES
K993528 05/31/2000 RUSCH EMERGENCY MASK RUSCH, INC. RONALD YOUNG
K001429 05/26/2000 MODIFICATION TO ACCUDEXA BONE DENSITOMETER SCHICK TECHNOLOGIES, INC. DANIEL MICHAELI
K992823 05/12/2000 SPIROVIT SP-2, PNEUMOCHECK II SCHILLER AG MARKUS BUETLER
K001140 05/03/2000 IDS5 IMAGE DISPLAY SYSTEM SECTRA AB HERMAN OOSTERWIJK
K000578 05/05/2000 SERIM LEUKOCYTE ESTERASE TEST STRIPS SERIM RESEARCH CORP. ROBERT J CARRICO
K993520 05/03/2000 H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS SERV-A-PURE CO. RICHARD C HERZBERGER
K001128 05/23/2000 NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K001065 05/23/2000 DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR SHEEN MORE ENT. CO., LTD. KEN HUANG
K001155 05/23/2000 DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR SHEEN MORE ENT. CO., LTD. KEN HUANG
K982101 05/02/2000 SHELHIGH NO-REACT DURA SHIELD SHELHIGH, INC. SHLOMO GABBAY
K991422 05/03/2000 POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) SHEN WEI (USA), INC. BELLE L CHOU
K001315 05/26/2000 MODIFICATION TO KION ANESTHESIA SYSTEM SIEMENS ELEMA AB DAVE SIMARD
K000672 05/02/2000 HELIODENT VARIO SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K994350 05/23/2000 NEER III TOTAL SHOULDER SYSTEM SMITH & NEPHEW, INC. NEAL DEFIBAUGH
K991031 05/10/2000 COLORADO II SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K000720 05/30/2000 SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE SOMNUS MEDICAL TECHNOLOGIES, INC. STEVEN J OJALA
K001438 05/16/2000 SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR SOMNUS MEDICAL TECHNOLOGIES, INC. STEVEN J OJALA, PH.D
K992819 05/11/2000 WAND PLUS SPINTECH, INC. DANIEL J MANELLI
K001367 05/31/2000 FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX ST. JUDE MEDICAL, INC. PAUL CORNELISON
K001346 05/24/2000 ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX ST. JUDE MEDICAL, INC. PAUL CORNELISON
K983068 05/31/2000 RELIANCE FAMILY OF WASHER-DISINFECTORS STERIS CORPORATION RAYMOND URSICK
K001444 05/15/2000 STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 STERITEC PRODUCTS, INC. LINDA NELSON
K000493 05/15/2000 STRYKER IRRIGATION TUBE SET STRYKER ENDOSCOPY MARK KUIPER
K000348 05/03/2000 COLORADO MICRODISSECTION NEEDLE STRYKER LEIBINGER KRISTYN R KELLEY
K000349 05/03/2000 MOTORIZED MICRO MULTILEAF COLLIMATOR STRYKER LEIBINGER KRISTYN R KELLEY
K000530 05/17/2000 BELLEGLASS HP ENAMEL SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K000682 05/01/2000 SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K000816 05/04/2000 SHARP BRAND ACUPUNCTURE NEEDLES TCM SUPPLY CORP. WILLIAM HUNG LEE
K000179 05/15/2000 NUZONE NITRILE SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD CHIN-GUAN LOW
K000178 05/23/2000 NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN TERANG NUSA SDN BHD CHIN-GUAN LOW
K994329 05/26/2000 IIVS INTEGRATED IMAGE VIEWING STATION TERARECON, INC. DAVID W SCHLERF
K000665 05/02/2000 TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER TFX MEDICAL, INC. KARENANN J BROZOWSKI
K991803 05/05/2000 BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. THE BINDING SITE, LTD. JAY H GELLER
K991802 05/05/2000 BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K991801 05/05/2000 BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K991804 05/05/2000 BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. THE BINDING SITE, LTD. JAY H GELLER
K001241 05/09/2000 EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K001203 05/26/2000 OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K000140 05/03/2000 CLINI-DENT THE PRECIDENT GROUP WENDY BEDALE
K000577 05/05/2000 YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA THE YOSHIDA DENTAL MFG. CO., LTD. KIYOSHI YOSHIDA
K992192 05/12/2000 AIRPILOTMASK, MODEL TMS-900 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K000745 05/03/2000 SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM TILLOTSON HEALTHCARE CORP. THOMAS N TILLOTSON
K000849 05/19/2000 SOFTFORM FACIAL IMPLANT TISSUE TECHNOLOGIES, INC. JESSE KRAMER
K990331 05/31/2000 SURGEN VALVE TIVA MEDICAL JIM CAPUTO
K001035 05/23/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K000333 05/03/2000 STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD TRIAD SURGICAL TECHNOLOGIES, INC. BRIAN MCGAVIN
K000189 05/11/2000 PQ1 ULTRADENT PRODUCTS, INC. SCOTT E MOORE
K000993 05/26/2000 LIBERTY 9000 BREAST COIL USA INSTRUMENTS, INC. RONY THOMAS
K000974 05/23/2000 FOWLER ENDOCURETTE, MODEL CUR-XXX UTAH MEDICAL PRODUCTS, INC. KEVIN L CORNWELL
K000922 05/24/2000 PROTON VISION VARIAN ASSOC., INC. LINDA S NASH
K000597 05/17/2000 VITA RESPONSE VIDENT BARBARA J LEWANDOWSKI
K000327 05/02/2000 WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 VISX, INCORPORATED DAVID M PATINO
K000623 05/16/2000 SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY Y YINGLING
K000625 05/23/2000 SCANDINAVIAN IVF SCIENCES AB, G1.2 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY Y YINGLING
K000626 05/23/2000 SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000621 05/16/2000 SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000618 05/17/2000 SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K991348 05/17/2000 IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 VITROLIFE SWEDEN AB EILER ANDERSON
K001002 05/24/2000 WAKO LIPASE CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K001238 05/03/2000 LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K000719 05/30/2000 NEOCARE 20 MICRON BLOOD FILTER WHATMAN, INC. RANDALL D BATH
K001041 05/23/2000 AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K001280 05/15/2000 COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K000880 05/22/2000 THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K000879 05/22/2000 THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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