FDA 510(k) Decisions During December, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K011255 12/20/2001 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D LINE USA, INC. KAREN H RIGAMONTI
K012014 12/05/2001 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. EVE A CONNER
K013538 12/14/2001 ETHANOL ABBOTT LABORATORIES ALICIA SIMPSON
K013683 12/06/2001 MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE ABBOTT VASCULAR INC. PATTY HEVEY
K013972 12/17/2001 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 ACKARD LABORATORIES RICHARD HETTENBACH
K013380 12/18/2001 ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K013616 12/19/2001 POLARUS CAP SCREW ACUMED, INC. SHARI JEFFERS
K013302 12/17/2001 DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K012631 12/06/2001 REPROCESSED SOFT TISSUE ABLATORS ALLIANCE MEDICAL CORP. DON SELVEY
K013813 12/14/2001 MODIFICATION TO:APEX MEDICAL IF-4100 APEX MEDICAL CORP. ALAN CHANGE
K012029 12/31/2001 REMEDY MODEL 2Z12 APOLLO CORP. ADRIAN SWEEN
K012968 12/03/2001 APPLIED ACCESS SEAL APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K011212 12/20/2001 FILTERFLO H ARC MEDICAL, INC. HAL NORRIS
K013320 12/19/2001 BLUE LATEX EXAMINATION GLOVES, POWDER FREE ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K013334 12/13/2001 ENDOFLIP ARTHOCARE CORPORATION NICK WOODS
K013818 12/05/2001 AUTOGENESIS AUTOMATOR, MODEL M1000 AUTOGENESIS, INC. JAMES EDWARDS
K013231 12/03/2001 AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L AVID N.I.T., INC. SCOTT HENDERSON
K012988 12/05/2001 HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K012337 12/06/2001 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP. KENNETH T EDDS
K013568 12/21/2001 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP. KENNETH T EDDS
K013606 12/21/2001 ACS 180 HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K013406 12/18/2001 ADVIA CENTAUR HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K012183 12/27/2001 BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY BAYER DIAGNOSTICS CORP. BARBARA PREISEL-SIMMONS
K013842 12/13/2001 IMMUNO-TROL LOW CELLS BECKMAN COULTER, INC. LOURDES COBA
K014034 12/18/2001 MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) BECKMAN COULTER, INC. ANNETTE HELLIE
K013076 12/12/2001 SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K013800 12/21/2001 INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K013193 12/21/2001 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. CAROL J MORELLO
K012469 12/03/2001 RESORBABLE NO PROFILE SCREW AND WASHER BIOMET MANUFACTURING, INC. SARA B SHULTZ
K013657 12/03/2001 MODIFICATION TO: BIOMET HUMERAL CABLE PLATES BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K013534 12/17/2001 SELF-COUNTERSINKING BONE SCREW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K993836 12/19/2001 GENERATION 4 BONE CEMENT BIOMET, INC. MARY VERSTYNEN
K011139 12/20/2001 LORENZ LACTOSORB PANELS AND FASTENERS BIOMET, INC. TRACY J BICKEL
K012569 12/21/2001 MODIFICATION TO: INJECTABLE MIMIX BIOMET, INC. SARA B SHULTZ
K011451 12/10/2001 REUNITE FUSION SCREW BIOMET, INC. SARA BAILEY SHULTZ
K012572 12/03/2001 SOFT TISSUE SCREW AND WASHER BIOMET, INC. SARA B SHULTZ
K013055 12/07/2001 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K013050 12/10/2001 THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K013289 12/27/2001 BIOTEQUE VAGINAL PESSARIES BIOTEQUE AMERICA, INC. DENIS DORSEY
K013151 12/14/2001 ASMOTOM AUTOMATED TREPHINE SYSTEM BKG OPTHALMICS USA, INC. ART WARD
K013177 12/19/2001 MULTITAK SUTURE SNAP SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K013866 12/14/2001 CONVOY ADVANCED DELIVERY SHEATH KIT BOSTON SCIENTIFIC ANDREA L RUTH
K011889 12/21/2001 ULTRA -THIN SDS BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K013789 12/06/2001 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 BOSTON SCIENTIFIC, TARGET GEORGE J PRENDERGAST
K013928 12/03/2001 PAIN CARE 3200 BREG, INC. KATHLEEN BARBER
K011589 12/26/2001 CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M BYPASS LTD. JONATHAN S KAHAN
K012686 12/13/2001 CAIRD TECHNOLOGY HOLTER 2000 CAIRD TECHNOLOGY JAMES H BROWN
K013251 12/18/2001 SPIRIT 300 CAIRE, INC. ROGER BRIESE
K013907 12/18/2001 INVERNESS MEDICAL EARLY PREGNANCY TEST CAMBRIDGE DIAGNOSTICS IRELAND, LTD. AVRIL MURRAY
K013807 12/12/2001 MICROJET QUARK, MODEL U100 OR U40 CANE SRL DANIEL KAMM
K013753 12/10/2001 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR CANOPUS MEDICAL SUPPLY CO., LTD. ELIZABETH DENG
K013019 12/18/2001 "DATACAPTOR" CAPSULE TECHNOLOGIE DANIEL KAMM
K013901 12/20/2001 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) CARDIOFOCUS, INC. JOSEPH CURTIS
K013512 12/20/2001 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K012731 12/26/2001 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K011849 12/10/2001 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS CIRCON VIDEO WAYNE B STERNER
K013721 12/28/2001 SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC. THERESA LEINEN
K011454 12/13/2001 SPINE SCOPE, MODEL 2180 CLARUS MEDICAL, LLC. TOM BARTHEL
K013877 12/19/2001 CODMAN SLIM-LOC SYSTEM CODMAN & SHURTLEFF, INC. KATHRYN WUNDER
K013400 12/10/2001 SYNERGY FLOW COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K013804 12/10/2001 SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. DAVID U THOMAS
K013112 12/05/2001 FOCAL SIM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K011893 12/06/2001 COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES CONTACT COLOR SRL MARIA E DONAWA
K002958 12/18/2001 SHAPEABLE DOPPLER FLOW PROBE COOK VASCULAR, INC. THOMAS J KARDOS
K013916 12/20/2001 MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K981052 12/18/2001 CRESCO TI IMPLANT CONCEPT CRESCO TI SYSTEMS AB PER E NILSSON
K012327 12/20/2001 CSIST DICOM GATEWAY/IMAGE MANAGER CSIST CARL ALLETO
K013878 12/07/2001 CYBERMED, INC., V-WORKS CYBERMED, INC. GARY J ALLSEBROOK
K013423 12/12/2001 MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K013246 12/11/2001 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 DATEX-OHMEDA JOEL KENT
K001003 12/10/2001 Z-NET DEMITE LIMITED WILLIAM H.E. VON OEHSEN
K011958 12/04/2001 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT DENKA SEIKEN'S SEIYA SATO
K013430 12/17/2001 ACE BIO WIN TIBIAL NAILING SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013563 12/27/2001 LONG TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013352 12/17/2001 SUMMIT CEMENTED HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013880 12/07/2001 DAYLITE XENON LIGHT SOURCES DESIGNS FOR VISION, INC. AMY GRUMET-AVALLONE
K013178 12/18/2001 DC-UIBC-CO2-CAL, MODEL SE-153 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K013628 12/21/2001 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K013850 12/21/2001 STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K013915 12/27/2001 D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER DIDECO S.P.A. SHAWN RIEDEL
K013449 12/19/2001 MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K013786 12/17/2001 DRG ORTHOHEX SS BONE SCREW DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K013271 12/13/2001 DXS DIGITAL X-RAY SYSTEM DOUGLAS C. YOON, DDS DOUGLAS C YOON
K010793 12/20/2001 OXYLOG 1000, MODEL 2M86840 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K012390 12/18/2001 NO STEP ON SITE DEUG TEST CUP DRUG FREE ENTERPRISES PERRY RUCKER
K013686 12/07/2001 KODAK DIRECTVIEW TABLETOP CASSETTE EASTMAN KODAK COMPANY JUDITH A WALLACE
K013739 12/13/2001 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K010526 12/13/2001 MODIFICATION TO THE GRIP ELCARE INNOVATIONS, INC. ELROY T CANTRELL
K013861 12/06/2001 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE ELEKTA INSTRUMENT AB CAROL PATTERSON
K003324 12/06/2001 PLASMA SPRAYED SHOULDER ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K013493 12/13/2001 INDIGO OPTIMA LASER SYSTEM ETHICON ENDO-SURGERY, INC. LINDA HILL
K013413 12/03/2001 MICROMARK II TISSUE MARKER,MODEL C1535 ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K013226 12/20/2001 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT EVENFLO COMPANY, INC. MATTHEW G MCCARTY
K013211 12/05/2001 MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS EXACTECH, INC. ROBERT PAXSON
K013037 12/07/2001 EXCEL A.V FISUTAL NEEDLE SET EXELINT INTL. CO. ARMAND HAMID
K013256 12/07/2001 BI-3M NEEDLE-FREE INJECTOR SYSTEM FELTON INTERNATIONAL, INC. ALAN FELTON
K014024 12/18/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K013445 12/26/2001 OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES FLORIDA OPTICAL ENGINEERING, INC. RICHARD A GRIFFIN
K011939 12/27/2001 FOTONA DUALIS, FOTONA DUALIS PLUS FOTONA D.D. MOJCA VALJAVEC
K013438 12/20/2001 FRIALIT-2 ESTHETICBASE ABUTMENT FRIADENT GMBH CAROL PATTERSON
K013218 12/20/2001 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., INC. JOSEPH M AZARY
K013273 12/20/2001 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE FUKUDA DENSHI USA, INC. LARRY WALKER
K014058 12/21/2001 ENTEGRA PE PERSONAL DIGITAL ASSISTANT GENERAL ELECTRIC MEDICAL SYSTEMS D. DUERSTELER
K012660 12/20/2001 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES GIMMI GMBH DAGMAR MASER
K013446 12/20/2001 GLUSITE, MODEL GLU002 GLUSTITCH, INC. DON BLACKLOCK
K012258 12/03/2001 COMPANION MODEL 221, 321, 421 GOLDEN TECHNOLOGIES, INC. FRED KIWAK
K013092 12/13/2001 HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. JENNIFER P RIGGS
K013638 12/04/2001 MODIFICATION TO VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. NANCY E RALSTON
K013069 12/12/2001 BIOSPEED H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013070 12/12/2001 JAMSHIDI BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013071 12/12/2001 SECURCUT ASPIRATION BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013424 12/20/2001 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND HAND INNOVATIONS, INC. AL WEISENBORN
K013466 12/21/2001 SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 HELENA LABORATORIES PATRICIA FRANKS
K012583 12/11/2001 ACUGLIDE BRAND ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. YI FEN CHANG
K004008 12/13/2001 STRESS GUARD, MODEL HERDEV1 HERBO MEDEX INTERNATIONAL, INC. RICHARD KEEN
K013141 12/19/2001 MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC. JOSEPH S TOKARZ
K013772 12/03/2001 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K013688 12/05/2001 MODIFICATION TO XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K013676 12/05/2001 TRIDENT HEMISPHERICAL ACETABULAR SHELLS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K013475 12/20/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K013823 12/19/2001 XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012199 12/19/2001 DIGICAP HUMANA USA, INC. H.N. DUNNING
K012501 12/11/2001 H.M.T. ACUPUNCTURE NEEDLE HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. GEOFFREY HSU
K013060 12/10/2001 ICS MEDICAL MODEL VG-30 VIDEO GOGGLES ICS MEDICAL ROBERT M SIMENSON
K010166 12/03/2001 IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM IMAGYN MEDICAL TECHNOLOGIES, INC. JULIE POWELL
K013570 12/17/2001 OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K004047 12/18/2001 HOME-AWAY SYSTEM IN-X CORP. CHARLIE HENRY
K013333 12/07/2001 LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM INNOVATIVE GLOVES CO; LTD RAJEEV K SOOD
K013798 12/19/2001 PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K013516 12/13/2001 INVACARE ELEVATING SEAT OPTION ESS6 INVACARE CORP. RAE A FARROW
K013017 12/06/2001 MEDIGROUP KEY TUBE JANIN GROUP, INC. JOHN A NAVIS
K013698 12/21/2001 AST (SGOT) JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K013939 12/14/2001 JOSTRA FLOWPROBE FP-32E JOSTRA AG KATHLEEN JOHNSON
K013401 12/14/2001 K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 K-SYSTEMS, KIVEX BIOTEC LTD. JACOB MOLLENBACH
K011691 12/27/2001 KIMSTIM AURICULAR ELECTRODE KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. DONALD F GRABARZ
K013537 12/07/2001 ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) KOON SENG SDN.BHD LIM WENG HENG
K011960 12/21/2001 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "POCKETPRO OR POCKETPRO S4") LARES RESEARCH, INC. THOMAS H LOUISELL
K013553 12/19/2001 PRE-LOADED ULTRAFIX RC LINVATEC CORP. LAURA D SENEFF
K011197 12/14/2001 DERMACLEAR UV-B PHOTOTHERAPY SYSTEM LUMENIS C. ROBERT PAYNE JR.
K012025 12/03/2001 MACROPORE SURGIWRAP (TS) MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K003075 12/11/2001 KNIGHTSTAR 330 VENTILATOR MALLINCKRODT, INC. ANTHONY MULLIN
K013792 12/11/2001 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K012186 12/07/2001 MASTER & FRANK SURGICAL GOWNS (STERILE) MASTER & FRANK ENT. CO., LTD. JENNIFER REICH
K011845 12/04/2001 MILLCOMP MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K013244 12/07/2001 COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE MED GEN, INC. THEDORE BARASH
K013225 12/26/2001 INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE MEDAFOR, INC. PHILIP B JARVI
K013734 12/07/2001 MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K013995 12/21/2001 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K013098 12/07/2001 KIMAX REMOTE VIEWING STATION MEDICAL METRICS, INC. ANN TUNSTALL
K011202 12/31/2001 MSI BIPOLAR SHEATH MEDICAL SCIENTIFIC, INC. PAUL NARDELLA
K013761 12/06/2001 MEDLINE EXCEL RECLINCER WHEELCHAIR MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K013815 12/13/2001 MEDRAD QWIK-FIT SYRINGE MEDRAD, INC. FRANK W PELC III
K013013 12/04/2001 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. MEDTRONIC CARDIAC SURGICAL PRODUCTS ROGER W BRINK
K013063 12/11/2001 GRIP LOCK ANCHOR, MODEL 411374 MEDTRONIC NEUROLOGICAL MONAYA LEE
K013000 12/05/2001 MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 MEDTRONIC NEUROSURGERY JANET MCAULEY
K011144 12/03/2001 LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K013663 12/05/2001 CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K013829 12/19/2001 MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICK W TREHARNE
K014076 12/27/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K011406 12/27/2001 SPINAL MESH SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K011500 12/03/2001 MENTOR CONTOUR PROFILE TISSUE EXPANDER MENTOR CORP. DONNA CRAWFORD
K013788 12/11/2001 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 MERITS HEALTH PRODUCTS CO., LTD. WINSTON ANDERSON
K013505 12/19/2001 AUROFLUID PLUS METALOR TECHNOLOGIES USA BRUCE BARTON
K002113 12/04/2001 CTXA HIP; CTXA; QCT PRO CTXA HIP MINDWAYS SOFTWARE, INC. CHRISTOPHER CANN
K013040 12/07/2001 LIGHT SABER INTRODUCER NEEDLE MINRAD, INC. HOWARD M HOLSTEIN
K013047 12/06/2001 FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM MOJCA VALIJAVEC MOJCA VALJAVEC
K012088 12/18/2001 NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT NASTECH PHARMACEUTICAL COMPANY, INC. PETER C APRILE
K013024 12/04/2001 SELECTIVA GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K013992 12/13/2001 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS ROBERT SCHMIDT
K013419 12/20/2001 NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM NICOLET BIOMEDICAL DAVID W WAGNER
K013293 12/14/2001 NIPRO HYPODERMIC NEEDLE NIPRO MEDICAL CORP. KAELYN B HADLEY
K013287 12/03/2001 NIPRO SAFELET CATH NIPRO MEDICAL CORP. KAELYN B HADLEY
K013036 12/07/2001 NOMOS MOTORIZED CRANE II NOMOS CORP. FRANCIS X DOBSCHA
K013436 12/21/2001 NORMATEC PCD NORMATEC, INC. JONATHAN S KAHAN
K013377 12/20/2001 BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC. RICHARD LIPPMAN
K010850 12/17/2001 POLESTAR N-10 ODIN MEDICAL TECHNOLOGIES LTD. ADI ICKOWICZ
K010388 12/11/2001 SONDREX P.A.L. SYSTEM OHMEDA MEDICAL ALBERTO F PROFUMO
K013066 12/11/2001 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K013591 12/26/2001 XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K013110 12/19/2001 ANISEIKONIA INSPECTOR OPTICAL DIAGNOSTICS, INC. JOYCE DE WIT
K013900 12/21/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS MARLENE A SHULMAN
K011887 12/27/2001 AVALON CUP SYSTEM ORTHOPEDIC SOURCE INC. STEVEN L MANDELL
K013094 12/14/2001 ORTHOSONIX ENERGEX ORTHOSONIX, INC. RUSSELL PAGANO
K012762 12/11/2001 MJS POSTERIOR STABILIZED KNEE SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K013371 12/21/2001 UBIT-IR300 INFRARED SPECTROMETRY SYSTEM OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K012588 12/10/2001 OXOID PYLORI TEST KIT, MODEL DR0130M OXOID, LTD. ANDY HOLLINGSWORTH
K013028 12/06/2001 PALOMAR SLP 1000 PALOMAR MEDICAL PRODUCTS, INC. MARCY MOORE
K013410 12/06/2001 AT HOME DRUG TEST, MODEL 9064 PHAMATECH INC. CARL MONGIOVI
K013412 12/06/2001 AT HOME DRUG TEST, MODEL 9069 PHAMATECH INC. CARL MONGIOVI
K013409 12/06/2001 AT HOME DRUG TEST, MODEL 9074 PHAMATECH INC. CARL MONGIOVI
K013408 12/06/2001 AT HOME DRUG TEST, MODEL 9079 PHAMATECH INC. CARL MONGIOVI
K013407 12/06/2001 AT HOME DRUG TEST, MODEL 9084 PHAMATECH INC. CARL MONGIOVI
K013344 12/11/2001 INTERA I/T PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PETER ALTMAN
K013624 12/03/2001 MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH DENISE HALEY
K013451 12/18/2001 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K013340 12/20/2001 RT-PLUS KNEE ADDITIONAL COMPONENTS PLUS ORTHOPEDICS HARTMUT LOCH
K014099 12/21/2001 BIOSCANNER PLUS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K012108 12/19/2001 MEDPOR COATED TEAR DRAIN POREX SURGICAL, INC. HOWARD MERCER
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K013708 12/10/2001 REFERENCE CHECK, CATALOG NUMBER-RCN-10 PRECISION BIOLOGIC STEPHEN L DUFF
K013411 12/12/2001 PULPDENT CAVITY PREPARATION IV PULPDENT CORP. KENNETH J BERK
K013358 12/13/2001 DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. ROBERT DUFFY
K013943 12/18/2001 RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K013660 12/05/2001 GENETRA RADIOMED CORPORATION GORDON ROBERTS
K013661 12/03/2001 XPLAN 2.2 WITH THE BODY SYSTEM RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K011393 12/04/2001 RANDOX PHENYTOIN RANDOX LABORATORIES, LTD. P. ARMSTRONG
K013328 12/03/2001 REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 REMINGTON PRODUCTS COMPANY, L.L.C. PAMELA J FURMAN
K013200 12/14/2001 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 RENNELS MEDICAL CORP. DAVID LEE
K013027 12/06/2001 MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 RESPIRONICS HEALTHSCAN, INC. SUSAN D GOLDSTEIN-FALK
K012323 12/20/2001 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K012040 12/18/2001 RAMP MYOGLOBIN ASSAY RESPONSE BIOMEDICAL CORP. WILLIAM J RADVAK
K013367 12/13/2001 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH REYNOLDS MEDICAL LTD. GEORGE MYERS
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K013482 12/21/2001 ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K012324 12/05/2001 ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP. MIKE FLIS
K013379 12/12/2001 SAS STREPALERT SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K013801 12/13/2001 ULTRASAFE DENTAL INJECTION SYSTEM SAFETY SYRINGES, INC. THOMAS L HALL
K011323 12/17/2001 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 SALIMETRICS LLC. EVE SCHWARTZ
K013703 12/14/2001 SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M SANYO NORTH AMERICA CORP. SACHI KATAOKA
K013649 12/26/2001 SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS SAUFLON PHARMACEUTICALS, LTD. LIGIA DELACRUZ
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K013288 12/03/2001 NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E SGMP CO., LTD. JANNA TUCKER
K013327 12/14/2001 CTS-415 SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K010925 12/18/2001 SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E SIEMENS ELEMA AB DIANE WURZBURGER
K013586 12/28/2001 MAGNETOM TRIO SYSTEM SIEMENS MEDICAL SYSTEMS, INC. JAMIE YIEH
K013549 12/26/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K011907 12/18/2001 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM SIMS LEVEL 1, INC. GABRIEL J MURACA, JR.
K013056 12/21/2001 GELCLAIR CONCENTRATED ORAL GEL SINCLAIR PHARMACEUTICALS, LTD. PRISCILLA COX
K013659 12/06/2001 MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K013650 12/06/2001 ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH SHEILA M HEMEON-HEYER
K013727 12/07/2001 STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G SMART GLOVE CORP. SDN BHD NG YEW SOON
K012378 12/13/2001 3D HUMERAL HEADS SMITH & NEPHEW, INC. DAVID HENLEY
K013658 12/05/2001 MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS SMITH & NEPHEW, INC. DAVID HENLEY
K013989 12/19/2001 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. JANET JOHNSON GREEN
K013817 12/21/2001 GLO-SPEC SOL WEISS MD INC SOL WEISS
K014116 12/20/2001 HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL HOFFMAN
K013090 12/13/2001 SOPRO 67D OPERATING ROOM CAMERA SOPRO PIERRE MONTILLOT
K012268 12/03/2001 TRIMAX STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K013139 12/18/2001 STELLARTECH COAGULATION SYSTEM STELLARTECH RESEARCH CORP. JAMES R SANTOS
K013630 12/05/2001 ISITE RADIOLOGY STENTOR, INC. GARY J ALLSEBROOK
K013242 12/13/2001 AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS CORPORATION ROBERT H MCCALL
K013502 12/03/2001 SIMPLICITY CLASSIC WING QD INFUSION SET STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K013767 12/12/2001 SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K014091 12/31/2001 STRYKER PAINPUMP STRYKER CORP. NICOLE PETTY
K012380 12/03/2001 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY STRYKER LEIBINGER ROBIN L ROWE
K013935 12/13/2001 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K013031 12/07/2001 MOST OPTIONS SYSTEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K013132 12/20/2001 SIGN IM NAIL SURGICAL IMPLANT GENERATION NETWORK (SIGN) DOUG DONNELLY
K013337 12/13/2001 PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI SURGIN INC DON HAAR
K012415 12/18/2001 AURIS AEP SYNAPSYS, INC. JULIEN CHAUSSY
K013527 12/21/2001 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM SYNTHES (USA) BONNIE J SMITH
K011897 12/20/2001 NORIAN SRS BONE VOID FILLER SYNTHES (USA) ANGELA J SILVESTRI
K012945 12/03/2001 SYNTHES 2.4 MM CANNULATED SCREW SYNTHES (USA) MATTHEW M HULL
K013044 12/03/2001 SYNTHES 3.9 MM PELVIC SCREWS SYNTHES (USA) MATTHEW M HULL
K013248 12/19/2001 SYNTHES LCP DISTAL TIBIA PLATES SYNTHES (USA) MATTHEW M HULL
K013323 12/05/2001 TCI-31 LIFELONG OVULATION TESTER TCI NEW YORK ERIKA B AMMIRATI
K013317 12/17/2001 TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TEKMEDIC (M) SDN BHD KOK-KEE HON
K010443 12/11/2001 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K013849 12/03/2001 TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS TETRAD CORP. CHARLES F HOTTINGER
K012820 12/14/2001 AIA-PACK CTNI 2ND-GEN ASSAY TOSOH MEDICS, INC. LOIS NAKAYAMA
K013580 12/12/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013925 12/21/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013903 12/17/2001 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 TRIAD MEDICAL, INC. RITA GIEBEL
K013086 12/13/2001 WET LIGHT PERSONAL MOISTURIZER TRIGG LABORATORIES, INC. W. PATRICK NOONAN
K012514 12/21/2001 DIGIPAN / DPI TROPHY RADIOLOGIE MARIE-PIERRE LABAT-CAMY
K013556 12/31/2001 MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE TYCO HEALTHCARE DAVID A OLSON
K012071 12/03/2001 ENT LASERVISION UNION MEDICAL USA ANNIE VELEZ
K013860 12/19/2001 AUTO SUTURE SURGICAL STAPLES UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHESTER MCCOY
K013890 12/11/2001 SURGICAL DYNAMICS MENISCAL STAPLE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER SCHUCK
K013528 12/13/2001 CRYSTAL 5000 PHASES ARRAY TMJ COIL USA INSTRUMENTS, INC. RONY THOMAS
K011683 12/10/2001 NURVO 9000 ENDOCAVITARY COILS USA INSTRUMENTS, INC. RONY THOMAS
K013541 12/14/2001 SHOULDER COIL USA INSTRUMENTS, INC. RONY THOMAS
K011832 12/21/2001 VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012256 12/20/2001 GELBISH VASCULAR DILATOR VASCUMETRIX, LLC MIKE HAMMONS
K013308 12/20/2001 VENTLAB HYPERINFLATION BAG SYSTEM VENTLAB CORP. MARGE WALLS-WALKER
K011702 12/21/2001 VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX VERTIS NEUROSCIENCE, INC. LORI GLASTETTER
K013146 12/07/2001 VIATRONIC V3D CALCIUM SCORING VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K013702 12/27/2001 VICTORCH HCG TEST STRIP VICTORCH MEDITEK, INC. PIERCE LIU
K013678 12/27/2001 VICTORCH MEDITEK'S HCG TEST CARD VICTORCH MEDITEK, INC. PIERCE LIU
K012587 12/11/2001 RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE VIDAMED, INC. YI CHEN
K013282 12/14/2001 GORE INTRODUCER SHEATH W. L. GORE & ASSOCIATES, INC. R. LARRY PRATT
K013346 12/19/2001 GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W.L. GORE & ASSOCIATES,INC JACQUELINE KALBACH
K012839 12/31/2001 AUROPAL, ORDER-NO.: 2101 WIELAND EDELMETALLE GMBH & CO. GERHARD P0LZER
K013652 12/21/2001 WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K011953 12/21/2001 WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013035 12/07/2001 GUARDIAN LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K013942 12/31/2001 POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) WRP SPECIALTY PRODUCTS SDN. BHD. MOHD H HUSSEIN
K011244 12/10/2001 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K013991 12/27/2001 PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN H MCKELVEY


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