FDA 510(k) Applications Received During November, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K003512 11/14/2000 LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II A.R.C. LASER AG DANIEL HOEFER
K003677 11/29/2000 ABX PENTRA 60C+ HEMATOLOGY ANALYZER ABX DIAGNOSTICS BRUCE H DAVIS
K003557 11/17/2000 ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) ACON LABORATORIES, INC. NORA C.R. YORK
K003434 11/06/2000 ALLEGRO TB, ALLEGRO N ADAC LABORATORIES DAVID KOLESAR
K003670 11/28/2000 PATIENT DRAPE, SURGICAL ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K003612 11/22/2000 MICROSPEED EC MOTORSYSTEM GD650/GD653 AESCULAP, INC. JOYCE THOMAS
K003463 11/07/2000 SOCON SPINAL SYSTEM AESCULAP, INC. DAVID W SCHLERF
K003608 11/22/2000 SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY AESCULAP, INC. LISA M MILLINGTON
K003519 11/15/2000 YASARGIL PERMANENT ANEURYSM CLIPS AESCULAP, INC. JOYCE THOMAS
K003565 11/20/2000 HEARTSTREAM FR2 AED, MODEL M3860A,M3861A AGILENT TECHNOLOGIES, INC. GRETCHEN SOLBERG
K003622 11/24/2000 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K003621 11/24/2000 ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K010125 11/27/2000 INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003647 11/27/2000 INSTANT-VIEW BARBITURATE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003638 11/24/2000 MOJAVE CATARACT EXTRACTION SYSTEM ALLERGAN, INC. MARK O'DONNELL
K003509 11/14/2000 FLEXICAST AMERICAN DENT-ALL, INC. VACHAKAN H KHOIE
K003443 11/06/2000 SUCTION IRRIGATOR APPLIED MEDICAL ANIL BHALANI
K003624 11/24/2000 REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 ARTHROCARE CORP. BETTY M JOHNSON
K003651 11/27/2000 AURORA AURORA IMAGING TECHNOLOGY, INC. JAMES J ROGERS
K003570 11/20/2000 BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 BACCHUS VASCULAR, INC. ROBERT A CLARK
K003616 11/22/2000 COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K003412 11/02/2000 ADVIA CENTAUR RUBELLA IGG ASSAY BAYER CORP. WILLIAM J PIGNATO
K003553 11/17/2000 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K003461 11/07/2000 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC M. WENDY BOSSHARDT
K003488 11/13/2000 SYNCHRON CONTROL BECKMAN COULTER, INC. GAIL LEFEBVRE
K003542 11/17/2000 PREAMP CABLE, MODEL B400-1011PA BETA BIOMED SERVICES, INC. EJ SMITH
K003681 11/30/2000 BIO-LOGIC SLEEPSCAN NETLINK BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K003480 11/09/2000 BIOFIND BIO-SCAN, INC. BUTCH SMITH
K003641 11/27/2000 BIOLOK SCREW, BIOSTEON SCREW BIOCOMPOSITES LTD. J.STEPHEN BRATT
K003493 11/13/2000 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT BIOMET, INC. SARA A BAILEY
K003428 11/03/2000 ISS OFFSET HEADS BIOMET, INC. DALENE T BINKLEY
K003429 11/03/2000 MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL BIOMET, INC. DALENE T BINKLEY
K003494 11/13/2000 MIMIX BONE REPLACEMENT SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K003659 11/28/2000 PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 BIONX IMPLANTS, INC. TUIJA ANNALA
DEN000010 11/15/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFF DAHLEN
K003475 11/08/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFF DAHLEN
K003454 11/07/2000 A1-CS-SB Y-ADAPTER, MODEL 124 871 BIOTRONIK, INC. JON BURMBAUGH
K003398 11/01/2000 WIRECLIP TORQUER BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY JOCELYN KERSTEN
K003589 11/20/2000 VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT BRAINLAB AG STEFAN VILSMEIER
K003611 11/22/2000 PAIN CARE MULTI-PORT CATHETER, MODEL 2000L BREG, INC. KATHLEEN BARBER
K003492 11/13/2000 ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS CAMBRIDGE HEART, INC. JOHN GREENBAUM
K003689 11/30/2000 CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 CANON U.S.A., INC. SHEILA DRISCOLL
K003541 11/16/2000 DENLASER, MODEL 800 CAO GROUP, INC. TRACY S BEST
K003642 11/27/2000 PLACEMENT-PLUS CATHETER INNOVATIONS, INC. ROGER L RICHINS
K003455 11/07/2000 MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K003467 11/08/2000 CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE HERNON
K003586 11/20/2000 FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES CIBA-GEIGY CORP. STEVEN DOWDLEY
K003458 11/07/2000 SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 CLINICAL INNOVATIONS, INC. DEAN WALLACE
K003438 11/06/2000 SMART RAD CMT MEDICAL TECHNOLOGIES, LTD. YESHAYAHU RAZ
K003549 11/17/2000 CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS CODMAN & SHURTLEFF, INC. JAMES M FLAHERTY
K003564 11/20/2000 HAKIM PROGRAMMER AND TRANSMITTER CODMAN & SHURTLEFF, INC. LAURA O'GRADY
K003481 11/09/2000 CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 CODONICS, INC. GARY J ALLSEBROOK
K003614 11/22/2000 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM COHERENT STAR ILIRIJA ENCINAS
K003661 11/28/2000 SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. DAVID THOMAS
K003431 11/03/2000 ZEUS ROBOTIC SURGICAL SYSTEM COMPUTER MOTION, INC. DAVID THOMAS
K003410 11/02/2000 CONCENTRIC RETRIEVER, MODEL 90030 CONCENTRIC MEDICAL, INC. SAM LAZZARA
K003666 11/28/2000 TAPER-FIT TOTAL HIP SYSTEM CORIN U.S.A. JOEL K BATTS
K003567 11/20/2000 SERENOCEM, MODEL BC 010 CORINTHIAN MEDICAL LTD. DAGMAR MASER
K003503 11/13/2000 N LATEX CYSTATIN C DADE BEHRING, INC. REBECCA S AYASH
K003501 11/13/2000 N PROTEIN STANDARD UY CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K003419 11/02/2000 RCRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIETRAK
K003696 11/30/2000 STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD DADE BEHRING, INC. LAURENCE A POTTER
K003619 11/22/2000 DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K003630 11/24/2000 DANMAR PRODUCTS MICHIGAN CRANIAL HELMET DANMAR PRODUCTS, INC. KAREN A LINDNER
K003598 11/21/2000 DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 DATASCOPE CORP. JOANN WOLF
K003674 11/29/2000 NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP DAVOL, INC., SUB. C.R. BARD, INC. RUTH C FORSTADT
K003518 11/15/2000 RAPIDD HIGHSPEED DENTAL HANDPIECE DENTSPLY INTL. P. JEFFREY LEHN
K003451 11/07/2000 DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T DENVER BIOMEDICALS, INC. BONNIE VIVIAN
K003397 11/01/2000 COLLES C SERIES FRAME STERILE PACK DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003421 11/03/2000 DEPUY C-STEM SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003523 11/15/2000 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K003597 11/21/2000 IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K003579 11/20/2000 NARKOMED MRI-2, MODEL NM-MRI-2 DRAEGER MEDICAL, INC. MICHAEL A KELHART
K003529 11/16/2000 SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS EDAP TECHNOMED, INC. SCOTT J MINDREBO
K003442 11/06/2000 MODIFICATION TO EDI VERIS SYSTEM ELECTRO-DIAGNOSTIC IMAGING, INC. SHEILA W PICKERING
K003688 11/30/2000 VIEW READING STATION ELECTROMED INTL., LTD. JEAN-LUC DES GROSEILLIERS
K003473 11/08/2000 DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM ELSCINTEC SYSTEMS LTD. ELLIOT MARSHALL
K003528 11/16/2000 SANARUS CORE TISSUE BIOPSY SYSTEM ENDOCARE, INC. VINCENT CUTARELLI
K003497 11/13/2000 DISPOSABLE PRESSURE MONITOR ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K003615 11/22/2000 STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. BRUCE G PIEKARSKI
K003452 11/07/2000 POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D EP TECHNOLOGIES, INC. CHRISTINA ROWE
K003462 11/07/2000 ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 ERBE USA, INC. JOHN TARTAL
K003587 11/21/2000 CLEARGLIDE PRECISION BIPOLAR DEVICE ETHICON, INC. GREGORY R JONES
K003648 11/27/2000 FREEDLAND TENSION SYSTEM ETZEM TECHNOLOGIES, INC. AHAVA SHEIN
K003487 11/13/2000 "STIMATE N601 TENS" EVERYWAY MEDICAL INSTRUMENTS CO., LTD. DORA HSU YANG
K003627 11/24/2000 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET EXELINT INTERNATIONAL CO. ARMAND HAMID
K003644 11/27/2000 EYETECT TREMOR MONITOR UNIT (TMU) EYETECT, L.L.C. REBECCA M CUETO
K003665 11/28/2000 FADASSI MEDICAL FM-1 NO BLENDER FADASIS MEDICAL, INC. RAYMOND RIDDLE
K003540 11/16/2000 (DISPOSABLE) VAGINAL SPECULUM FEMINICA, INC. DENIS H DUBOIS
K003582 11/20/2000 FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 FLUIDSENSE CORP. THOMAS CONNELLY
K003453 11/07/2000 SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS FONAR CORP. LUCIANO BONANNI
K003498 11/13/2000 FRESENIUS OPTIFLUX 200A FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K003445 11/06/2000 FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K003613 11/22/2000 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL GE MEDICAL SYSTEMS LARRY A KROGER
K003408 11/02/2000 CT CORD IQ OPTION 1.0 GE MEDICAL SYSTEMS LARRY A KROGER
K003575 11/20/2000 MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K003573 11/20/2000 DIFFUSION TENSOR IMAGING OPTION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K003395 11/01/2000 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. E. JOSEPH MCMULLEN
K003441 11/06/2000 CASTLE MODEL 233HC STEAM STERILIZER GETINGE/CASTLE, INC. FREDERICK R CATT
K003590 11/21/2000 GRAMS POLYESTER NONABSORBABLE SUTURE GRAMSMED LLC ANTHONY J DIMERCURIO
K003495 11/13/2000 ANCURE LLIAC BALLOON CATHETER GUIDANT CARDIAC AND VASCULAR SURGERY JACQUELINE J JACKSON
K003569 11/20/2000 PLASMAKINETIC ENDOUROLOGY SYSTEM GYRUS MEDICAL LTD. DAVID KAY
K003532 11/16/2000 HARDY DISK, CEFPODOXINE, 10MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR, RAC
K003556 11/17/2000 HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003536 11/16/2000 HARDYDISK NAFCILLIN, 1 MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003537 11/16/2000 HARDYDISK RIFAMPIN, 5MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003690 11/30/2000 HARDYDISK SULFISOXAZOLE HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003686 11/30/2000 HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003554 11/17/2000 HARDYDISK TRIMETHOPRIM 5MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K003649 11/27/2000 TRITON HIP SYSTEM HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K003507 11/13/2000 MEDRELIEF HEALTHONICS, INC. T. WHIT ATHEY
K003405 11/01/2000 ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO HIGHLAND / MARIETTA, INC. JOHN NIKSA
K003403 11/01/2000 ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 HIGHLAND / MARIETTA, INC. JOHN NIKSA
K003413 11/02/2000 ALUMINA V40 HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003490 11/13/2000 OPUS ROD FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003471 11/08/2000 MAGNA TEK ESU-400 HUTTINGER MEDIZINTECHNIK GMBH & CO KG BERNHARD HUG
K003513 11/14/2000 TAXOL ADMINISTRATION SET ICU MEDICAL, INC. SALVADORE F PALOMARES
K003552 11/17/2000 ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN SA LINDA JALBERT
K003406 11/01/2000 GUARDED NEEDLE 2000 INTERNATIONAL MEDICAL DEVICE PARTNERS, INC. JAMES R GREENWOOD
K003450 11/07/2000 INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS INTRATHERAPEUTICS, INC. AMY PETERSON
K003561 11/20/2000 INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 INVACARE CORP. RAE ANN FARROW
K003646 11/27/2000 SUTUREGROOVE WEIGHT SIZING SET IOP, INC. JASON MALECKA
K003448 11/06/2000 DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K003634 11/24/2000 DW 272 #1 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003632 11/24/2000 DW 273 #1 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003635 11/24/2000 DW 276 #3 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003633 11/24/2000 DW 277 #4 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003407 11/01/2000 SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003693 11/30/2000 DIRECT BILIRUBIN JAS DIAGNOSTICS, INC. DAVID JOHNSON
K003603 11/21/2000 BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE JELENKO CO. RAPHAEL JUDKINS
K003683 11/29/2000 AVANTE CURELIGHT JENERIC/PENTRON, INC. ANNMARIE TENERO
K003551 11/17/2000 VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 JOSTRA AG KATHLEEN JOHNSON
K003483 11/09/2000 MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) LAKE REGION MFG., INC. JIM KLOSTERMAN
K003538 11/16/2000 TDP CQ-27 HEAT LAMP LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K003560 11/17/2000 MAR COR SERVICES BICARB SYSTEM MAR COR SERVICES, INC. MICHAEL ROBERTSON
K003521 11/14/2000 DISPO-MED 7.6 LITER SHARPS CONTAINER MASTER BENEFITS, INC. JOHNNY TABOADA
K003672 11/28/2000 MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE MEDGE PLATFORMS, INC. GUSTAVO EDUARDO ABELLA
K003685 11/30/2000 MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL MEDICAL ADVANCES, INC. MICHAEL LEIGH
K003682 11/30/2000 MEDCOMP Z-CATH MEDICAL COMPONENTS, INC. JEANNE M CUSH
K003489 11/13/2000 NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 MEDICAL ILLUMINATION INTERNATIONAL, INC. DAVID GLOVER
K003404 11/01/2000 SUPRASPERM SYSTEM MEDICULT A/S RONALD G LEONARDI
K003525 11/15/2000 VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY ALLSEBROOK
K003687 11/30/2000 VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K003667 11/28/2000 REVEAL PLUS INSERTABLE LOOP RECORDER MEDTRONIC VASCULAR STACEY P WESSMAN
K003535 11/16/2000 STYLET KIT, MODELS 6254,6282,6293 MEDTRONIC VASCULAR KAREN CLEMENT
K003695 11/30/2000 MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES MICRO-MEDICAL DEVICES, INC. GEORGE COLEMAN
K003584 11/20/2000 NEOLYNX SCREENING APPLICATION MANAGER MICROMASS, INC. DANIEL J DILLON
K003594 11/21/2000 CARRIAZO BARRAQUER SINGLE USE MICROKERATOME MORIA, INC. DAVID CONRAD
K003476 11/09/2000 MPS ACACIA PAIN KIT MPS ACACIA FERGIE F FERGUSON
K003505 11/13/2000 KFA-127 KNEE, FOOT AND ANKLE ARRAY MRI DEVICES CORP. TOM SCHUBERT
K003655 11/27/2000 PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003508 11/14/2000 NC-STAT NEUROMETRIX, INC. JAMES R VEALE
K003631 11/24/2000 SMARTWAVE IF 2000 NEWWAVE MEDICAL LLC. ROBERT ARMSTRONG
K003520 11/15/2000 NEXAN SYSTEM, MODEL NX-300 NEXAN LTD DAVID L WEST
K003444 11/06/2000 MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. ROBERT D WAXHAM
K003563 11/20/2000 POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE NING BO YUJIANG RUBBER & PLASTIC CO. JANNA P TUCKER
K003394 11/01/2000 APPALEAD GW+03XXXXXXR SERIES NIPRO MEDICAL CORP. CARY GOLDSMITH
K003620 11/22/2000 NSI HEXED AND NON-HEXED IMPLANT SYSTEM NSI GRETA M HOLS
K003643 11/27/2000 NUMED Z-MED PTV CATHERERS NUMED, INC. NICHELLE LAFLESH
K003522 11/15/2000 SALUTE ONUX MEDICAL, INC. GREGORY E SANCOFF
K003482 11/09/2000 PROCLUDE-SENSITIVE ORTEK THERAPEUTICS, INC. JULES T MITCHEL
K003609 11/22/2000 N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 OSTEOMETER BIOTECH A/S PER QVIST
K003517 11/14/2000 OTRES TOOTHBRUSH SANITIZER MODEL TB100W OTRES, LLC. DAVID BUDDINGH
K003548 11/17/2000 "PADPRO SYSTEM" DEFIBRILLATOR ELECTRODE ADAPTERS PADPRO LLC. DANIEL KAMM
K003460 11/07/2000 PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K003414 11/02/2000 VARELISA TG (THYROGLOBULIN) ANTIBODIES, PHARMACIA & UPJOHN CO. KAREN E MATIS
K003516 11/14/2000 GYROSCAN INTERA 3.0T PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K003459 11/07/2000 PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K003437 11/06/2000 ODYSSEY LX, MODEL 211320 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. RONALD J MARTONE
K003496 11/13/2000 CANNULATED SCREW SYSTEM PIONEER SURGICAL TECHNOLOGY AMY H MOMMAERTS
K003504 11/13/2000 RT-PLUS MODULAR CEMENTED KNEE COMPONENTS PLUS ORTHOPEDICS HARMTMUT LOCH
K003656 11/27/2000 X-POSURE SYSTEM VERSION 2 MAMMO PRONOSCO A/S JONATHAN S KAHN
K003576 11/20/2000 Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 QUINTON, INC. DAVID HIMES
K003534 11/16/2000 PENTRA 5D R & D SYSTEMS, INC. KENNETH T EDDS
K003500 11/13/2000 REBSTOCK YASARGIL ANEURYSM CLIP REBSTOCK - INSTRUMENTE GMBH DIETER REBSTOCK
K003499 11/13/2000 REMVIEW SLEEP RECORDER, MODEL 320 RESPIRONICS, INC. DAVID J VANELLA
K003417 11/02/2000 MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K003676 11/29/2000 RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR RITA MEDICAL SYSTEMS ERIN MAZZONE
K003426 11/03/2000 ALGINATE IMPRESSION MATERIAL RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K003427 11/03/2000 ZINC PHOSPHATE CEMENT RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K003400 11/01/2000 CRP HS TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003409 11/02/2000 ELECSYS FSH CALSET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003411 11/02/2000 ELECSYS TESTOSTERONE CALSET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003484 11/09/2000 NETRA WORKSTATION AND NETRAMD SOFTWARE SCIMAGE, INC. MICHAEL PETER
K003472 11/08/2000 INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM SEQUAL TECHNOLOGIES, INC. RON HALL
K003675 11/29/2000 SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. LEE HUNG TE CHE
K003515 11/14/2000 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 SHIMADZU MEDICAL SYSTEMS MASAAKI SHIBATA
K003514 11/14/2000 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 SHIMADZU MEDICAL SYSTEMS MASAAKI SHIBATA
K003559 11/17/2000 TCI (TINNITUS CONTROL INSTRUMENT) SIEMENS HEARING INSTRUMENTS, INC. DAVID S SLAVIN
K003558 11/17/2000 TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) SIEMENS HEARING INSTRUMENTS, INC. DAVID S SLAVIN
K003550 11/17/2000 INFINITY ETCO2 + RESPIRATORY MECHANICS POD SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GREEN
K003623 11/24/2000 INTERACTIVE REAL TIME SCANNING PACKAGE SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K003628 11/24/2000 MAGNETOM RHAPSODY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K003566 11/20/2000 COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS SMITH & NEPHEW, INC. DAVID HENLEY
K003572 11/20/2000 DYONICS CONTROL RF SYSTEM SMITH & NEPHEW, INC. MARK KIERAS
K003596 11/21/2000 SMITH & NEPHEW RESTIM SMITH & NEPHEW, INC. CORDELL C HOFFINS
K003599 11/21/2000 SMITH & NEPHEW SUTURE ANCHOR SMITH & NEPHEW, INC. WILLIAM MCCALLUM
K003399 11/01/2000 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL A HOFFMAN
K003663 11/28/2000 SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE SPACELABS MEDICAL, INC. IRENE JAWORSKI
K003526 11/16/2000 SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) SPECIALTY ULTRAVISION, INC. GAROLD L EDWARDS
K003555 11/17/2000 SOLO-SAFE SAFETY SYRINGE, SIZE-3CC SPECTRUM BIOTECH, INC. IAN MCDOUGALL
K003662 11/28/2000 SPINE WORKS COLLAR SPINE WORKS DAN FARLEY
K003423 11/03/2000 ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. FRANCIS HONG
K003446 11/06/2000 SYMMETRY AORTIC CLIP SYSTEM ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC. ROBERT L SHERIDAN
K003447 11/06/2000 PROTRACT PRESS FIT HIP STEM STELKAST COMPANY DONALD A STEVENS
K003577 11/20/2000 STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT STERIS CORPORATION RAYMOND URSICK
K003533 11/16/2000 CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L STERITEC PRODUCTS, INC. LINDA NELSON
K003433 11/06/2000 NEURO-TRAIN III (3) STERNE EQUIPMENT CO., LTD. THOMAS WALLACE
K003660 11/28/2000 LEIBINGER NEURO CLIP SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
K003486 11/13/2000 STEREOTACTIC FRAME BASED SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
K003543 11/17/2000 STRYKER PAINPUMP PCA STRYKER INSTRUMENTS NICOLE PETTY
K003626 11/24/2000 DEVILBISS HUMIDIFIER SUNRISE MEDICAL HHG, INC. ALLAN R JONES
K003422 11/03/2000 EDTA ROOT CANAL CLEANSER SUPER GLIDE, INC. VICTOR L RATKUS
K003436 11/06/2000 SURGI-VISION GUIDEWIRE COIL SURGI-VISION, INC. NANCY E TALOR
K003640 11/27/2000 MINIENDO III SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSELL
K003650 11/27/2000 PERMLASTIC 3 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003658 11/28/2000 TEMP-BOND NE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003393 11/01/2000 MAXILLARY DISTRACTOR SYNTHES (USA) THOMAS M MAGUIRE
K003527 11/16/2000 MODIFICATION TO SYNTHES (USA) POLYPIN SYNTHES (USA) THOMAS M MAGUIRE
K003591 11/21/2000 TENSCARE, MODEL TENS XL-2 TENS CARE LTD. BERNARD J TREMAINE
K003547 11/17/2000 NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD CHIN-GUAN LOW
K003545 11/17/2000 NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE TERANG NUSA SDN BHD CHIN-GUAN LOW
K003629 11/24/2000 MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 TERRAY CORP. STEVE WANG
K003604 11/21/2000 ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K003425 11/03/2000 CLIRANS E-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORP. YUK-TING LEWIS
K003424 11/03/2000 PINNACLE R/O II OR RADIFOCUS INTRODUCER II TERUMO MEDICAL CORP. YUK-TING LEWIS
K003571 11/20/2000 SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE TERUMO MEDICAL CORP. BARBARA SMITH
K003669 11/28/2000 KAPPA IMMAGE FREELITE KIT THE BINDING SITE, LTD. JAY H GELLER
K003671 11/28/2000 LAMBDA IMMAGE FREELITE KIT THE BINDING SITE, LTD. JAY H GELLER
K003511 11/14/2000 KENDALL-LTP TURNER SAVE-A-LINE THE LUDLOW COMPANY, LP KATHLEEN M MURPHY
K003583 11/20/2000 LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 TRACE AMERICA, INC. THOMAS DOLLAR
K003470 11/08/2000 EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 TUTTNAUER CO. LTD. MARK YACURA
K003479 11/09/2000 U-SYSTEMS ULTRASOUND SYSTEM USI-2000 U-SYSTEMS, INC. SHEILA W PICKERING
K003449 11/07/2000 E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) ULRICH ALBER GMBH & CO. SUSAN D GOLDSTEIN-FALK
K003457 11/07/2000 UNIGRAFT UNICARE BIOMEDICAL STAN YANG
K003580 11/20/2000 UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER UNISENSOR AG ROBERT N CLARK
K003636 11/24/2000 PORTALVISION VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K003469 11/08/2000 EECP THERAPY SYSTEM, MODEL TS3 VASOMEDICAL, INC. THOMAS R VARRICCHIONE
K003510 11/14/2000 INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 VISUALIZATION TECHNOLOGY, INC. NORMA LEMAY
K003639 11/24/2000 VITREA 2 CT PERFUSION OPTION VITAL IMAGES, INC. ROBERT C SAMEC
K003439 11/06/2000 VIVANT BREAST LESION LOCALIZATION DEVICE VIVANT MEDICAL, INC. GEORGE HERMANN
K003607 11/22/2000 ONYX-RAD TELEMEDICINE PACS VIZTEK, INC. JOSIP CERMIN
K003684 11/29/2000 PERCUSSIVENEB, MODEL PN-2001 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K003668 11/28/2000 AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 WALLAC OY GUNNEL LAAKSONEN
K003664 11/28/2000 DELFIA NEONATAL IRT KIT, MODEL A005-110 WALLAC OY GUNNEL LAAKSONEN
K003415 11/02/2000 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE WANG & LI, INC. ANN D MCGONIGLE
K003396 11/01/2000 BURN JEL PLUS WATER-JEL TECHNOLOGIES, LLC. MICHAEL PISANI
K003402 11/01/2000 WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION WELCON, INC. PAMELA PAPINEAU
K003618 11/22/2000 WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 WHITESIDE BIOMECHANICS, INC. DEBRA MEYER
K003653 11/27/2000 STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K003568 11/20/2000 XISCAN 6000 IMAGING SYSTEM XITEC, INC. SHEILA M HEMEON-HEYER
K003440 11/06/2000 SOFTLASE - SURGICAL DIODE LASER SYSTEM ZAP LASERS, INC. DAVID W SCHLERF
K003478 11/09/2000 TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 ZIMMER, INC. KAREN CAIN


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