FDA 510(k) Decisions During March, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K003723 03/27/2001 3M LITTMANN 3M COMPANY LINDA JOHNSEN
K010828 03/29/2001 DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP A & D ENGINEERING, INC. JERRY WANG
K001856 03/07/2001 SUPERCROSS CATHETER ABBOTT VASCULAR INC. DAUN S PUTNAM
K003746 03/13/2001 3D-DOCTOR ABLE SOFTWARE CORP. YECHENG WU
K010390 03/09/2001 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K003557 03/15/2001 ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) ACON LABORATORIES, INC. NORA C.R. YORK
K003185 03/20/2001 FS ACTIVATOR III ACTIVATOR METHODS INTERNATIONAL, LTD ARLAN W FUHR
K003965 03/16/2001 MRI SAFE INSTRUMENTS AESCULAP, INC. LISA M MILLINGTON
K010571 03/28/2001 ADC QS/IPD WORKSTATION AGFA CORP. T. WHIT ATHEY
K010453 03/02/2001 M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K000655 03/26/2001 PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE AHAVA STEIN AHAVA STEIN
K010223 03/16/2001 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) AMERICAN CONTACT LENS, INC. MARTIN DALSING
K010277 03/26/2001 AMS FASCIAL-ANCHORING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA LINKE
K002382 03/14/2001 'ALL 2000' % OXYGEN ANALYZER ANALYTICAL INDUSTRIES, INC. PATRICK J PRINDIBLE
K003787 03/08/2001 NEWTOM QR-DVT 9000 APERIO SERVICES, LLC GREGORY W BOWMAN
K003923 03/20/2001 APEX MODULAR ZIRCONIA FEMORAL HEAD APEX SURGICAL, LLC. EDWARD J CHEAL
K010182 03/09/2001 VCF PERSONAL LUBRICANT APOTHECUS PHARMACEUTICAL CORP. GARY L YINGLING
K004015 03/13/2001 BEAM BLOCK TRAYS ARPLAY MEDICAL S.A. RICHARD BORGI
K010062 03/13/2001 STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM ARPLAY MEDICAL S.A. RICHARD BORGI
K010330 03/02/2001 ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U ARROW INTL., INC. WILLIAM PAQUIN
K002507 03/21/2001 TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC. THOMAS D NICKEL
K003777 03/06/2001 CARIS SITE MARKER ARTEMIS MEDICAL, INC. ROBIN BUSH
K003816 03/09/2001 ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM ARTHREX, INC. VERNON C BROWN
K010568 03/27/2001 ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM ARTHROCARE CORP. BETTY M JOHNSON
K003971 03/21/2001 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K003975 03/19/2001 BAUMER CEMENTED HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K003976 03/19/2001 BAUMER MULLER HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K002705 03/28/2001 EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 BAXA CORP. CARL STEINECK
K003747 03/19/2001 C1-INHIBITOR MICROTITER ASSAY DEVICE BAXTER HEALTHCARE CORP. ARLENE VIDOR
K010201 03/29/2001 BAYER ADVIA IMS SYSTEM BAYER CORP. FREDICK CLERIE
K003553 03/21/2001 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K010188 03/01/2001 BD ECLIPSE HYPODERMIC NEEDLE BD MEDICAL SYSTEMS GREG W MORGAN
K010428 03/13/2001 ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 BECKMAN COULTER, INC. BRENT TABER
K010358 03/05/2001 VIGIL SEROLOGY CONTROL LEVEL C BECKMAN COULTER, INC. ANNETTE HELLIE
K010572 03/12/2001 BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE BECTON DICKINSON AND CO. JAMES STAFFIERA
K003861 03/08/2001 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) BENZ RESEARCH AND DEVELOPMENT CORP. MARTIN DALSING
K000814 03/29/2001 FINGER PULSE METER BHS INTL., INC. CHRIS REDDING
K010523 03/15/2001 MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST BINAX, INC. PAMELA S ANGELL
K003867 03/09/2001 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) BIOFILM, INC. ROBERT L DE ARMOND
K003908 03/08/2001 SEROJET BIOJECT, INC. NANCY J GERTLAR
K001353 03/13/2001 MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM BIOMEDICAL ENT., INC. W. CASEY FOX
K001354 03/13/2001 MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM BIOMEDICAL ENT., INC. W. CASEY FOX
K001581 03/20/2001 LACTOSORB 5.0 MM WASHER BIOMET, INC. CAROL LAUSTER
K010560 03/20/2001 PORTRAIT FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K010687 03/14/2001 BIOSORBFX AND BIOSORBPDX MESH BIONX IMPLANTS, INC. TUIJA ANNALA
K003752 03/23/2001 BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K010266 03/16/2001 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 BIOSITE INCORPORATED JEFFREY R DAHLEN
K010405 03/13/2001 7230 ULTRASOUND IMAGING SYSTEM WITH TEI BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K003362 03/01/2001 ASTRONOMER+WITH SLD BOSTON SCIENTIFIC CORP. ANDREA J BOUMIS
K003929 03/22/2001 NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. JODI L GREENIZEN
K010610 03/27/2001 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K010707 03/29/2001 ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 BOSTON SCIENTIFIC, TARGET IRENE JAWORSKI
K004034 03/08/2001 MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 BRANAN MEDICAL CORP. RAPHAEL WONG
K010505 03/09/2001 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K010649 03/20/2001 EXHALE DOPPLER SYSTEM BRONCUS TECHNOLOGIES, INC. TIMOTHY R WILLIAMS
K010567 03/28/2001 OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR C.R. BARD, INC. PEGGY KEIFFER
K002019 03/30/2001 RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K010393 03/12/2001 APOLLO MOBILE "C" ARM SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K010392 03/12/2001 ATHENA REMOTE CONTROLLED RF SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K010391 03/12/2001 ATLAS MULTI-PURPOSE DSA SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K003301 03/15/2001 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB CONSTANCE G BUNDY
K010389 03/23/2001 CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K010191 03/14/2001 Y2000 POCKET RESCUE CHEEN HOUNG ENT. CO. LTD. JAY WANG
K003345 03/26/2001 AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K010636 03/23/2001 FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT CIBA VISION CORPORATION ALICIA M PLESNARSKI
K003826 03/08/2001 FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K010126 03/12/2001 PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) CL-TINTERS MARTIN S KNOPF
K003614 03/13/2001 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM COHERENT STAR ILIRIJA ENCINAS
K003085 03/07/2001 CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 CONCENTRIC MEDICAL, INC. LINDA BRADLEY
K002254 03/16/2001 COOK PRESSURE MONITORING CATHETER COOK, INC. APRIL LAVENDER
K002286 03/22/2001 LDOB OCCLUSION BALLOON CATHETER COOK, INC. MARY A GOSSARD
K003715 03/01/2001 COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II COOLTOUCH CORP. DONALD V JOHNSON
K010445 03/16/2001 PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM CORDIS CORP. SAM MIRZA
K010511 03/01/2001 MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K001398 03/30/2001 REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K004039 03/29/2001 CYNOSURE PHOTOGENICA NEO-V CYNOSURE, INC. GEORGE CHO
K010061 03/14/2001 DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND DADE BEHRING, INC. RICHARD M VAUGHT
K010206 03/16/2001 DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 DADE BEHRING, INC. RICHARD M VAUGHT
K003503 03/13/2001 N LATEX CYSTATIN C DADE BEHRING, INC. REBECCA S AYASH
K003501 03/15/2001 N PROTEIN STANDARD UY CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K003998 03/07/2001 FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K010463 03/15/2001 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES DATEX-OHMEDA, INC. JOEL C KENT
K010037 03/22/2001 DAUM DOUBLE-SHOOT BISOPSY GUN DAUM GMBH CHRISTINA SMITH
K004031 03/28/2001 NT SWIFT; TITEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES DENTAL POWER, INC. JOHN SCHOEFFEL
K010642 03/20/2001 PLEURX PLEURAL CATHETER AND DRAINAGE KITS DENVER BIOMEDICALS, INC. NANCY SAUER
K010320 03/01/2001 MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED KAREN F JURCZAK
K010367 03/09/2001 MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K003875 03/01/2001 TI-REPLICA HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K002829 03/26/2001 DJ ORTHOPEDICS FEMORAL ANCHOR DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K003960 03/21/2001 DJ ORTHOPEDICS TIBIAL ANCHOR DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K003993 03/26/2001 DORNIER MEDILAS D SKINPULSE LASER SYSTEM ("SKINPULSE") DORNIER SURGICAL PRODUCTS, INC. WALTER PAYERL
K010082 03/12/2001 D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM DUTCH OPHTHALMIC USA, INC. MARK W FURLONG
K004016 03/27/2001 SHEER THIN AROMAS BLUE LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K004036 03/27/2001 SHEER THIN AROMAS GREEN LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K010028 03/30/2001 SHEER THIN AROMAS RED LATEX CONDOM EAGLE TWE, INC. KEITH HEINTZ
K004051 03/29/2001 SHEER THIN AROMAS YELLOW LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K010437 03/13/2001 MODIFICATION TO EBI XFIX DFS RAIL SYSTEM EBI, L.P. PATRICIA FLOOD
K010482 03/20/2001 ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 ECHOCATH, INC. DAVID LYONS
K001734 03/26/2001 FOGARTY VALVULOTOME, MODEL 700091 EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K003955 03/15/2001 LASEREX INTEGRE, MODEL LP2532 ELLEX MEDICAL PTY. LTD. KEITH DEGENHARDT
K002154 03/22/2001 K.E.A.T. EMD ELECTRONIC MEDICAL DEVICES, CORP. JEAN CLAUDE MARTY
K003897 03/22/2001 ENDIUS BIPOLAR SHEATH ENDIUS, INC. SUSAN FINNERAN
K010535 03/19/2001 TRIFIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K010339 03/07/2001 ENDOCARE PERCUTANEOUS ACCESS SET ENDOCARE, INC. VINCENT CUTARELLI
K010356 03/27/2001 LATEX EXAMINATION GLOVES-POWDER FREE ENZYMIC TECHNOLOGIES SDN BHD LEE HONG YEN
K010347 03/27/2001 LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE ENZYMIC TECHNOLOGIES SDN BHD LEE HONG YEN
K010718 03/23/2001 FLEXI-SITE SP02 EAR SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K003864 03/06/2001 INJEX 50 SYSTEM EQUIDYNE SYSTEMS, INC. JIM BARLEY
K003352 03/20/2001 ESCREEN SYSTEM ESCREEN, INC. JONATHAN S KAHAN
K003953 03/16/2001 INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 ETHICON ENDO-SURGERY, INC. JACKIE HUGHES
K003952 03/16/2001 INDIGO LASEROPTIC TREATMENT SYSTEM ETHICON ENDO-SURGERY, INC. JACQUELYN A HUGHES
K010165 03/12/2001 ERO SCAN OAE TEST SYSTEM ETYMOTIC RESEARCH STEVE ISEBERG
K010434 03/13/2001 OPTETRAK B-SERIES TOTAL KNEE SYSTEM EXACTECH, INC. LISA SIMPSON
K010085 03/15/2001 EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) EXCEL TECH. LTD. SONJA MARKEZ
K010088 03/26/2001 REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) EXCEL TECH. LTD. CAMERON MAHON
K010084 03/16/2001 REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP EXCEL TECH. LTD. DEBBIE DAVY
K010089 03/26/2001 REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) EXCEL TECH. LTD. DEBBIE DAVY
K010090 03/26/2001 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) EXCEL TECH. LTD. SONJA MARKEZ
K010087 03/19/2001 XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP EXCEL TECH. LTD. CAMERON MAHON
K010562 03/13/2001 ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K992706 03/15/2001 GALIX GBI -3S-LP GALIX BIOMEDICAL INSTRUMENTATION, INC. JORDAN GAVRIELIDES
K003947 03/13/2001 FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE MEDICAL SYSTEMS LARRY A KROGER
K010641 03/30/2001 GE CT-PET SYSTEM GE MEDICAL SYSTEMS, INC. D DUERSTELER
K003837 03/12/2001 FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM GE OEC MEDICAL SYSTEMS TED PARROT
K010329 03/01/2001 LOGIQ 500 GENERAL ELECTRIC CO. ALLEN SCHUH
K004014 03/16/2001 MD 30 COMPACT GENERAL PROJECT CORNELIA DAMSKY
K010217 03/18/2001 4 PORT, 4 WAY STOPCOCK GEORGE LOO, MD GEORGE LOO
K003803 03/07/2001 GENERAL SURGICAL LAPAROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K010686 03/21/2001 KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. GARY C BAUMAN
K003590 03/05/2001 GRAMS POLYESTER NONABSORBABLE SUTURE GRAMSMED LLC ANTHONY J DIMERCURIO
K003017 03/13/2001 GRAMSORB SYNTHETIC ABSORBABLE SUTURE GRAMSMED LLC A. J DIMERCURIO
K010425 03/15/2001 EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) HDC CORP. EARL SMART
K010442 03/08/2001 KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 HEINZ KURZ DAGMAR S MASER
K010617 03/15/2001 SPIFE IFE CALIBRATOR AND CONTROL KIT HELENA LABORATORIES PAT FRANKS
K010616 03/28/2001 DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A HMI INDUSTRIES, INC. JACQUELINE PERCELL
K010403 03/26/2001 PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K004044 03/02/2001 HOMMED SENTRY III PATIENT MONITOR SYSTEM HOMMED LLC. TOMMIE J MORGAN
K010310 03/20/2001 MODIFICATION TO TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K010402 03/14/2001 SMOOTH-FLO CIRCUIT HUDSON RESPIRATORY CARE, INC. CHARLES MIERKIEWICZ
K002548 03/06/2001 FETAL ASSIST HUNTLEIGH DIAGNOSTICS LTD. B.J. COLLEYPRIEST
K004011 03/27/2001 IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS IMPRA, INC. LORI CHAVEZ
K010352 03/14/2001 CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. HANNA MARTTILA
K010351 03/15/2001 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. HANNA MARTTILA
K003271 03/20/2001 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG CAROLYN BITETTI
K010515 03/22/2001 MODIFICATION TO SYNERGY SPINAL SYSTEM INTERPORE CROSS INTL. LYNN M RODARTI
K002489 03/02/2001 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM INTUITIVE SURGICAL, INC. DAVID CASAL
K010364 03/22/2001 MCC-MIV ONE 2 ONE SOFTWARE INVACARE CORP. RAE ANN FARROW
K003939 03/21/2001 VENTURE HOME FILL II, MODEL IOH 200 INVACARE CORP. EDWARD A KROLL
K010381 03/06/2001 D.SIGN 30 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003835 03/23/2001 JAS MAGNESIUM REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K010416 03/08/2001 HERACERAM 75 JELENKO CO. RAPHAEL JUDKINS
K010414 03/27/2001 R & D DESIGNATION AP-035 JENSEN INDUSTRIES, INC. JOHN SLANSKI
K010611 03/27/2001 R & D DESIGNATION AP-047 JENSEN INDUSTRIES, INC. JOHN SLANSKI
K010160 03/27/2001 WILLI GELLER CREAPEARL JENSEN INDUSTRIES, INC. JOHN SLANSKI
K002665 03/19/2001 WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 K-JUMP HEALTH CO., LTD. JOHATHAN S KAHAN
K003113 03/27/2001 KSEA SCB-RUI SCO KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K010040 03/09/2001 SLEEVED FILTER KING SYSTEMS CORP. CHARLES A BURT
K003765 03/06/2001 LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) LASERSCOPE PAUL H HARDMAN
K003369 03/08/2001 LIFECARE COMPACT TENS DEVICE LIFECARE LTD. AHAVA STEIN
K002088 03/06/2001 SHAVER ABLATOR LINVATEC CORP. LAURA D SENEFF
K003984 03/19/2001 SUPER REVO SUTURE ANCHOR LINVATEC CORP. LAURA D SENEFF
K004006 03/26/2001 SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER LUMENIS, INC. KAREN BAKER
K004028 03/27/2001 ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING MAERSK MEDICAL, LTD. LARA N SIMMONS
K003913 03/16/2001 HINT AUDIOMETER, OR HINT MAICO-DIAGNOSTICS DANIEL EGGAN
K010419 03/06/2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K004050 03/15/2001 PANASONIC TELE-HOMECARE SYSTEM MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. DAVID L WEST
K002789 03/21/2001 MEDEVIEW SYSTEM MEDEVIEW.COM JEFFREY O BOILY
K000724 03/22/2001 MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 MEDICA S.R.L. JAMES DELANEY
K003344 03/15/2001 MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 MEDICAL DEPOT, INC. ART WARD
K010495 03/09/2001 CENTURA PHOTOTHERAPY SPOTLIGHT MEDICAL ILLUMINATION INTERNATIONAL, INC. DAVID GLOVER
K003156 03/22/2001 BLASTASSIST SYSTEM MEDICULT A/S RONALD G LEONARDI
K003404 03/22/2001 SUPRASPERM SYSTEM MEDICULT A/S RONALD G LEONARDI
K003163 03/22/2001 SYNVITRO FLUSH MEDICULT A/S RONALD G LEONARDI
K002153 03/13/2001 ULTRASONIC NEBULIZER, MODEL NE-520 MEDISANA USA, INC. GUENTER GINSBERG
K010338 03/07/2001 ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 MEDIVANCE, INC. LYNNE ARONSON
K003979 03/19/2001 MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K002869 03/27/2001 LOCALISA CARDIAC NAVIGATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES THOMAS PARKER
K003873 03/29/2001 MENTOR SELF-CATH CLOSED SYSTEM MENTOR CORP. DONNA A CRAWFORD
K003784 03/05/2001 MENTOR SELF-CATH PLUS MENTOR CORP. DONNA A CRAWFORD
K010609 03/16/2001 ACCUSONIC, MODEL AS-260 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K003794 03/30/2001 ELISA TEST, SEROLOGY MICRO DETECT, INC. MEDHI ALEM
K010497 03/22/2001 SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 MICRO THERAPEUTICS, INC. EBEN GORDON
K003584 03/19/2001 NEOLYNX SCREENING APPLICATION MANAGER MICROMASS, INC. DANIEL J DILLON
K003594 03/09/2001 CARRIAZO BARRAQUER SINGLE USE MICROKERATOME MORIA, INC. DAVID CONRAD
K003899 03/15/2001 IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM MRI DEVICES CORP. WILLIAM DINEHART
K010096 03/05/2001 MULTI CARE THERAPEUTIC VIBRATOR MULTICEPT A/S KLAUS VAMMEN
K010589 03/19/2001 MICROWAVAE DELIVERY SYSTEM #MW2000 MW MEDICAL, INC. GREG HOLLAND
K010298 03/16/2001 MN-4 COARSE MANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K010521 03/09/2001 NICOLET VERSALAB NICOLET BIOMEDICAL DAVID W WAGNER
K010019 03/19/2001 STERILE SUBDERMAL NEEDLE ELECTRODES NICOLET BIOMEDICAL, INC. GARY SYRING
K003299 03/09/2001 OPD-SCAN, MODELS ARK-10000 AND ARK-9000 NIDEK CO., LTD. CAROL PATTERSON
K010224 03/18/2001 NPAC MULTI-USE THERMOMETER, MODEL TD400 NORM PACIFIC AUTOMATION CORP. CHI-CHU WU CHEN
K010359 03/14/2001 INNOVO NOVO NORDISK A/S ROBERT FISCHER
K003820 03/08/2001 DISPOSABLE CB-PE MICROKERATOME BLADES OASIS MEDICAL, INC. YVONNE FERNANDEZ
K010222 03/21/2001 OHMEDA MEDICAL GIRAFFE INCUBATOR OHMEDA MEDICAL ALBERTO F PROFUMO
K000977 03/23/2001 COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS OLSON MEDICAL SALES, INC. GARY A COURTNEY
K010591 03/15/2001 OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER OLYMPUS OPTICAL CO., LTD. TSUYOSHI YANAI
K003824 03/08/2001 OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI OMNISONICS MEDICAL TECHNOLOGIES DOUG CHARLAND
K010256 03/26/2001 ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL OPTI-CENTRE LABORATORIES MARTIN DALSING
K004021 03/27/2001 F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. CONNIE WHITE-HOY
K003893 03/01/2001 VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X ORATEC INTERVENTIONS, INC. LINDA GUTHRIE
K010024 03/14/2001 O2/CO2 NASAL FILTERLINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K001535 03/20/2001 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION ORTHOTEC, L.L.C. DAVID W SCHLERF
K002150 03/09/2001 SONICAID FM820, SONICAID FM830 OXFORD INSTRUMENTS STEVE VALE
K003886 03/01/2001 PALOMAR SPALIGHT PULSED LIGHT SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K002862 03/13/2001 PRONEB ULTRA MODEL NUMBER 85B0100 PARI HOLDING CO. DEBRA A PEKAR
K003951 03/21/2001 PECTOFIX STERNAL REPAIR WIRE PECTOFIX, INC. ERIC BANNON
K010645 03/30/2001 AT HOME DRUG TEST, MODEL 9063 T PHAMATECH CARL A MONGIOVI
K010650 03/30/2001 AT HOME DRUG TEST, MODEL 9073 T PHAMATECH CARL A MONGIOVI
K010646 03/30/2001 AT HOME DRUG TEST, MODEL 9083 T PHAMATECH CARL A MONGIOVI
K010651 03/30/2001 AT HOME DRUG TEST, MODEL 9133 T PHAMATECH CARL A MONGIOVI
K010435 03/12/2001 PHILIPS BV PULSERA/ENDURA PHILIPS MEDICAL SYSTEMS, INC. MARCIA JONES
K003705 03/01/2001 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. AL MEMMOLO
K003725 03/01/2001 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS PIE MEDICAL COLLEEN J HITTLE
K010116 03/15/2001 PLANMED SOPHIE, PLANMED SOPHIE CLASSIC PLANMED OY BOB PIENKOWSKI
K001412 03/20/2001 PM 1800 CONSERVING DEVICE PRECISION MEDICAL, INC. CONLEY WALLACE
K002907 03/08/2001 PVS 1300 NEURO GUIDE WIRE PRECISION VASCULAR SYSTEMS, INC. JOHN R RAGAZZO
K003058 03/08/2001 LASER 3 SPSC300 PRIDE MOBILITY PRODUCTS CORP. GENE R KULON
K003059 03/01/2001 LASER 4SPSC340 PRIDE MOBILITY PRODUCTS CORP. GENE R K ULON
K010608 03/20/2001 MODIFICATION TO LAP TOP VENTILATOR (LTV) PULMONETIC SYSTEMS, INC. DARRYL SHELBY
K010598 03/23/2001 SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL QUANTIMETRIX CORP. EVA LASZLO
K002689 03/06/2001 SWABSITE SWABBABLE VALVE, MODEL 245000 QUEST MEDICAL, INC. DOUG BRYAN
K010409 03/16/2001 CBC-SF R & D SYSTEMS, INC. KENNETH T EDDS
K010548 03/12/2001 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K003346 03/15/2001 RANDOX GLUCOSE (GOD/PAP) RANDOX LABORATORIES, LTD. P. ARMSTRONG
K010606 03/16/2001 SAFARI RANGER ALL SEASON CORP. RON STEWART
K994381 03/30/2001 PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY
K010538 03/30/2001 PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E RD MEDICAL MFG., INC. CARLOS A RODRIGUEZ-GARCIA
K004040 03/29/2001 REDTECH GIPC 2000 RED-TECH, INC. GARY MOCNIK
K001708 03/01/2001 PROFOX SOFTWARE, MODEL 920M-41 RESPIRONICS GEORGIA, INC. GERRY RICHARDSON
K010263 03/29/2001 REMSTAR PLUS CPAP SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K010052 03/19/2001 RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER RESPIRONICS, INC. DAVID J VANELLA
K000180 03/02/2001 TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K010240 03/27/2001 POLYCARBOXYLATE (PCA) CEMENT RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K010362 03/07/2001 ACCU-CHEK COMFORT CURVE TEST STRIP ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003846 03/19/2001 ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003411 03/01/2001 ELECSYS TESTOSTERONE CALSET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K010588 03/28/2001 ELECSYSCA 15-3 II ASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K002706 03/16/2001 ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K010498 03/20/2001 WRISTWATCH BLOOD PRESSURE MONITOR A46 ROSSMAX INTERNATIONL LTD. MICHAEL YEH
K002468 03/02/2001 SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 SAN UP S.A. SUSAN D GOLDSTEIN-FALK
K003382 03/30/2001 SARSTEDT NEEDLE PROTECTOR SARSTEDT, INC. PETER RUMSWINKEL
K010289 03/07/2001 SCIMEDX PHASE II MPO IGG ANTIBODY EIA SCIMEDX CORP. GARY LEHNUS
K010287 03/16/2001 SCIMEDX PHASE II PR3 IGG ANTIBODY EIA SCIMEDX CORP. GARY LEHNUS
K010285 03/01/2001 CONTOUR PROFILE LASER SCITON, INC. PETER N ALLEN
K010382 03/01/2001 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I SENSIDYNE, INC. GEORGE MASON
K010097 03/30/2001 POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) SHEN WEI (USA), INC. BELLE L CHOU
K010721 03/30/2001 AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM SIEMENS MEDICAL CORP. PRAVEEN NADKARNI
K003550 03/07/2001 INFINITY ETCO2 + RESPIRATORY MECHANICS POD SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GREEN
K010640 03/20/2001 SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K003328 03/01/2001 ACCUCLOT CONTROL I, MODEL A4089 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K003267 03/15/2001 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K010652 03/30/2001 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K003329 03/01/2001 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K010158 03/22/2001 THROMBOMAX-HS WITH CALCIUM, MODEL T6540 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K010426 03/08/2001 PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER SIMS DELTEC, INC. LISA J STONE
K002274 03/07/2001 SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW SMITH & NEPHEW, INC. TEDD GOSIAN
K002095 03/02/2001 SNAP MODEL 6 SNAP LABORATORIES, L.L.C. GIL RAVIV
K010176 03/27/2001 CALEX CONDITIONER STEPHEN M. KORAL, D.M.D. STEPHEN M KORAL
K010373 03/13/2001 SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) STERLING MEDIVATIONS, INC. JOEL DOUGLASS
K003758 03/07/2001 ALLOFIT ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K010622 03/29/2001 PRESSURE TRAK, MODEL 222-B SUNTECH MEDICAL INSTRUMENTS, INC. DAVID GALLICK
K010041 03/07/2001 SLT DIFFUSER FIBER SURGICAL LASER TECHNOLOGIES, INC. DAVIS WOODWARD
K003808 03/01/2001 TAKE 1 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003717 03/01/2001 INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. HARALD JUNG
K003911 03/13/2001 TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) TERRAY CORP. STEVE WANG
K010103 03/15/2001 SURSHIELD WINGED INFUSION SET TERUMO MEDICAL CORP. BARBARA SMITH
K010147 03/01/2001 ENA EIA KIT THE BINDING SITE, LTD. JAY H GELLER
K010146 03/01/2001 ENA EIA KIT RANGE THE BINDING SITE, LTD. JAY H GELLER
K002901 03/28/2001 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER THE KENDALL COMPANY PAUL EVANS
K010663 03/30/2001 POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE TONG RUHN MEDICAL PRODUCTS CO., LTD. ANTONIO L GIACCIO
K010631 03/15/2001 NEMIO TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K004045 03/06/2001 SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003995 03/16/2001 SPECULITE/ORALLITE TRYLON CORP. MARTIN LONKY
K003449 03/16/2001 E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) ULRICH ALBER GMBH & CO. SUSAN D GOLDSTEIN-FALK
K010070 03/15/2001 ULTRAPAK NEHA ULTRADENT PRODUCTS, INC. MARKUS R GEE
K002297 03/15/2001 YORAMED, MODEL T-202 UNITED YORAM DISTRIBUTORS, INC. MORRIS MIZRAHI
K010013 03/26/2001 LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 VALLEYLAB, INC. KEVIN RANDALL
K003173 03/13/2001 ASPIRE COVERED STENT AND DELIVERY CATHETER VASCULAR ARCHITECTS, INC. KEVIN F MACDONALD
K010218 03/16/2001 VISTAKON (HEFILCON C) CONTACT LENSES VISTAKON MICHAEL J TERSAK
K002454 03/07/2001 BREAS HA50 HUMIDIFIER, MODEL HA50 VITAL SIGNS, INC. THOMAS W DIELMANN
K000881 03/08/2001 PERFADEX SOLUTION FOR ORGAN PRESERVATION VITROLIFE SWEDEN AB KARL A POSSELT
K010427 03/15/2001 LORENZ FIDUCAIL SCREW WALTER LORENZ SURGICAL, INC. KIM REED
K010031 03/20/2001 NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM WESCOR, INC. WAYNE K BARLOW
K010447 03/15/2001 MODIFICATION TO ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC. STEVE CHARTIER
K002696 03/21/2001 WHITTLESTONE BREASTPUMP WHITTLESTONE, INC. BRUCE MCKENDRY
K002315 03/15/2001 WISEBANDS SKIN CLOSURE DEVICE WISEBANDS LTD. MARY PAGE
K010058 03/21/2001 IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK WITT BIOMEDICAL CORPORATION LORRAINE R FREDES
K003910 03/19/2001 NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN MCKELVEY


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