FDA 510(k) Decisions During June, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K011200 06/14/2001 GILB, MODEL 8010 3M COMPANY KAREN O'MALLEY
K011442 06/05/2001 ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 ABBOTT LABORATORIES FRANK POKROP
K010953 06/06/2001 CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY ABBOTT LABORATORIES JOHN DEAN
K010553 06/18/2001 PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY ABBOTT LABORATORIES JANET CONNOLLY
K011752 06/28/2001 GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY ACCUFAST, INC. DON LOGAN
K010950 06/27/2001 CYPRESS SYSTEM ACUSON CORP. HOWARD M HOLSTEIN
K010791 06/08/2001 REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) ADSIS LTD. JONATHAN S KAHAN
K010760 06/11/2001 ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS ADVANCED RENAL TECHNOLOGIES, INC. ROBIN CALLAN
K011183 06/15/2001 OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE ADVANCED SURGICAL CONCEPTS (ASC) MARY MCNAMARA-CULLINANE
K010921 06/25/2001 ADVANTAGE MARIJUANA (THC) HOME DRUG TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K003759 06/28/2001 AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR AESCULAP, INC. DAVID W SCHLERF
K010752 06/11/2001 AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY AESCULAP, INC. LESLIE YOUNG
K011375 06/29/2001 AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE AESCULAP, INC. STEVE REITZLER
K010634 06/11/2001 HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B AGILENT TECHNOLOGIES, INC. RICHARD J PETERSEN
K011578 06/08/2001 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K010965 06/27/2001 A-LINE AEP MONITOR ALARIS MEDICAL SYSTEMS, INC. RENEE FLUET
K010966 06/08/2001 MEDLEY SP02 MODULE, MODEL 8220 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K011132 06/08/2001 AIRLIFE HEPA FILTER ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K010862 06/07/2001 ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K011234 06/13/2001 BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L AMERICAN BIOCURVE, INC. MARTIN DALSING
K011316 06/13/2001 BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T AMERICAN CONTACT LENS, INC. MARTIN DALSING
K010990 06/22/2001 AMS SLING FIXATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K003999 06/28/2001 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 AMERICAN TELECARE, INC. CHARLES RICHARD ABBRUSCATO
K010884 06/20/2001 TITANIUM COMPRESSION ANCHOR SYSTEM ANCHOR MEDICAL TECHNOLOGIES GREG HOLLAND
K011593 06/21/2001 MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K011601 06/08/2001 ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX ARDO MEDICAL AG EVA KRAHENBUHL
K003778 06/08/2001 BREAST-BOARD (MULTIPLE) ARPLAY MEDICAL S.A. RICHARD BORGI
K001917 06/06/2001 PARODI CATHETER FOR ANGIOGRAPHY (PARCA) ARTERIA MEDICAL SCIENCE, INC. STEVE CHERNOFF
K011172 06/19/2001 ARTHREX BIO-TRANSFIX ARTHREX, INC. VERNON BROWN
K011007 06/12/2001 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 ARTHREX, INC. ANN WATERHOUSE
K011634 06/19/2001 ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 ARTHROCARE CORP. BETTY M JOHNSON
K011083 06/28/2001 ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND ARTHROCARE CORP. BRUCE PROTHRO
K011534 06/15/2001 EEG MIS MONITOR MODEL # A-2000; BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K010473 06/06/2001 SPARROWHAWK DISPOSABLE ATC TECHNOLOGIES, INC. PAUL KIERCE
K002409 06/28/2001 MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER AUTOMATIC MEDICAL TECHNOLOGIES, INC. MICHAEL MITSUNAGA
K010847 06/19/2001 K'FIX AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K011819 06/19/2001 RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K010029 06/29/2001 HOME HEALTH MONITORING SYSTEM AVID CARE CORP. WILLIAM GENTHE
K010697 06/06/2001 UNIQUE AMBULATORY EEG AXON SYSTEMS, INC. HOWARD BAILIN
K011417 06/08/2001 ULTRASOUND SCANNER, TYPE 2102 B-K MEDICAL A/S VILLY BRAENDER
K003570 06/06/2001 BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 BACCHUS VASCULAR, INC. ROBERT A CLARK
K011446 06/14/2001 BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES BARRIERMED, INC. CARLO PONCIPE
K011317 06/28/2001 MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP. VICKI L DREWS
K011156 06/14/2001 BCI 3403 SLEEP SCREENING PULSE OXIMETER BCI, INC. DONALD ALEXANDER
K010770 06/12/2001 BCI ADVISOR VITAL SIGNS MONITOR (9200) BCI, INC. DONALD ALEXANDER
K011103 06/13/2001 BD SPRING BASED SYRINGE BD GREG W MORGAN
K011858 06/19/2001 INTERLINK THREADED LOCK CANNULA BD GREGORY W MORGAN
K003062 06/06/2001 BACTEC MGIT 960 SIR KITS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DENNIS R MERTZ
K003259 06/13/2001 ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 BECKMAN COULTER, INC. DENISE THOMPSON
K010429 06/05/2001 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 BECKMAN COULTER, INC. BRENT TABER
K011465 06/08/2001 SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO BECKMAN COULTER, INC. MARY B TANG
K011222 06/25/2001 PORTABELL, MODEL 4200 BELL DENTAL PRODUCTS, LLC. DAN BELL
K011494 06/08/2001 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL BIO-RAD DONNA CHAPMAN
K011579 06/26/2001 LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 BIO-RAD YVETTE LLOYD
K011675 06/22/2001 THE AUTOTAC SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. DONALD E DALTON
K010209 06/12/2001 ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K011509 06/13/2001 BARRETT UNICONDYLAR TIBIAL BEARING BIOMET, INC. TRACY J BICKEL
K011554 06/26/2001 LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT BIOMET, INC. PATRICIA SANDBORN BERES
K011137 06/19/2001 RESORBABLE HAMMERTOE PIN BIOMET, INC. SARA A BAILEY
K011795 06/13/2001 WORLAND UNICONDYLAR TIBIAL BEARING BIOMET, INC. TRACY J BICKEL
K010983 06/13/2001 PLLA PIN BIONX IMPLANTS, INC. TUIJA ANNALA
K011075 06/27/2001 EASYBELL BIOPSYBELL S.A.S. LUCIO IMPROTA
K010026 06/21/2001 EMBOGOLD MICROSPHERE BIOSPHERE MEDICAL, INC. JOHN D BONASERA
K011159 06/08/2001 ONE-STEP PLUS BISCO, INC. CYNDY ORIS
K010874 06/21/2001 6F MACH 1, MODEL 34356-XXX BOSTON SCIENTIFIC CORP. TODD KORNMANN
K010856 06/06/2001 STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K011015 06/22/2001 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. PEGGY KEIFFER
K010974 06/18/2001 RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K010184 06/22/2001 CHESS HAND SURGERY SYSTEM CANICA DESIGN, INC. GEORGETTE ROY
K011389 06/21/2001 HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) CANTERBURY HEALTH LABORATORIES MAURICE OWEN
K003927 06/26/2001 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 CHEEN HOUNG ENT. CO. LTD. JAY WANG
K003035 06/06/2001 CLARREN HELMET CHILDREN'S HOSPITAL & MEDICAL CENTER DAVID J BLOCH
K011336 06/12/2001 PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK CHURCHILL MEDICAL SYSTEMS, INC. KEITH PAULCH
K011180 06/27/2001 CT/MASTER, VERSION 1.0 COLUMBIA SCIENTIFIC, INC. CHARLES D STOCKHAM
K011462 06/13/2001 OIL FOR TISSUE CULTURE CONCEPTION TECHNOLOGIES GRACE HOLLAND
K011677 06/22/2001 MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER CONTINUUM ELECTRO-OPTICS, INC. RONALD KOHLHARDT
K010055 06/14/2001 COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH COOK VASCULAR, INC. THOMAS J KARDOS
K003920 06/15/2001 CORDIS M3 PTA DILATATION CATHETER CORDIS CORP. CHARLES (CHUCK) J RYAN
K010083 06/06/2001 TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A CORDIS CORP. KAREN WILK
K002885 06/21/2001 DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP DADE BEHRING, INC. RADAMES RIESGO
K011035 06/14/2001 DIMENSION DRUG CALIBRATOR, MODEL DC22B DADE BEHRING, INC. RICHARD M VAUGHT
K011033 06/07/2001 DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 DADE BEHRING, INC. RICHARD M VAUGHT
K010745 06/27/2001 EMS 3000 DAN MED, INC. THOMAS SANDGAARD
K011611 06/08/2001 CARDIOCAM MODEL 9CSY0799 DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS S ORENSEN
K011670 06/26/2001 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE DATEX-OHMEDA JOEL C KENT
K011179 06/05/2001 DELDENT ULTRASONIC INSERTS DELDENT LTD. ALAN EDEL
K011425 06/05/2001 CARMEN DENTAURUM, INC. THOMAS J ANDERSON
K011428 06/05/2001 TRICERAM DENTAURUM, INC. THOMAS J ANDERSON
K011831 06/28/2001 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS DENVER BIOMEDICAL, INC. BONNIE VIVIAN
K011020 06/01/2001 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMEDICALS, INC. NANCY SAUER
K010972 06/12/2001 ISOLA BAND CLAMP DEPUY ACROMED LISA GILMAN
K011367 06/15/2001 EXCEL FRACTURE CEMENTED HIP STEM DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K011047 06/28/2001 GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT DEPUY ORTHOPAEDICS, INC. MARCIA ARENTZ
K003026 06/19/2001 PFC SIGMA LUGGED TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K010780 06/12/2001 TROCHANTERIC NAIL DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003182 06/27/2001 ORTHOGENESIS LPS SYSTEM DEPUY, INC. JANET G JOHNSON
K010963 06/06/2001 STA-LIATEST FREE PROTEIN S TEST KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B LE
K010455 06/07/2001 ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN DIAGNOSTICA-STAGO ANDREW LOC B LE
K011572 06/15/2001 QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) DIGIRAD CORP. COREY STEWART
K011390 06/06/2001 BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K010988 06/19/2001 FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K010901 06/19/2001 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K011211 06/18/2001 FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW DMG USA, INC. PAMELA PAPINEAU
K011773 06/22/2001 DORNIER LITHOTRIPTER 140("DOLI 140") DORNIER SUZANNE COURTNEY
K010093 06/14/2001 NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K003068 06/25/2001 SAVINA DRAGER MEDIZINTECHNIK GMBH JIM BRENNAN
K010724 06/07/2001 SOLA 700,SOLA 500, SOLA 300 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K011119 06/25/2001 BRACHYSEED PD-103 MODELS #PD1 DRAXIMAGE, INC. RICHARD J FLANAGAN
K010703 06/25/2001 INTER-VIAL DUOJECT MEDICAL SYSTEMS, INC. DANIEL MACDONALD
K011383 06/25/2001 MICRODOSE CATH, MODELS 90121-201, -202, -203 DURECT CORP. JEFF P MILLER
K002410 06/06/2001 FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE DYSPHAGIA, L.L.C. MARCY FREED
K011697 06/27/2001 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P. FREDERIC TESTA
K011711 06/29/2001 MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM EBI, L.P. PATRICIA FLOOD
K011516 06/08/2001 INFANT FLOW SYSTEM, MODEL M672P EME (ELECTRO MEDICAL EQUIPMENT) LTD. STUART CORNER
K010903 06/06/2001 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. GENE DIPOTO
K010922 06/06/2001 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K011040 06/15/2001 CRYOCARE CARDIAC SURGICAL SYSTEM ENDOCARE, INC. VINCENT CUTARELLI
K011587 06/01/2001 SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP ENTRACON CORP. PAUL ZANNECHIA
K003741 06/01/2001 JET SYRINGE MODEL-100500 EQUIDYNE SYSTEMS, INC. JIM BARLEY
K011394 06/29/2001 LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM ESPE DENTAL AG ANDREAS PETERMANN
K010870 06/18/2001 LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 ETHICON ENDO-SURGERY, INC. DENNIS HAHN
K010311 06/29/2001 LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE EUROMI SA JOSEPH M AZARY
K011617 06/08/2001 LIFEJET PRINTER 400 FERRANIA S.P.A. STABILIMENTO DI FERRANIA RICCARDO GENTA
K011309 06/22/2001 LUTE VLC; CORE VLC FIRST SCIENTIFIC LIMITED ADE AKINMADE
K011295 06/27/2001 RESTORE-PF VIC; RESTORE-PF VLC CAPSULE FIRST SCIENTIFIC LIMITED ADE AKINMADE
K003894 06/25/2001 ORACLE ORAL MASK FISHER & PAYKEL HEALTHCARE, LTD. DARRYN ALEXANDER
K003973 06/01/2001 RESPIRATORY HUMIDIFIER, MODEL HC150 FISHER & PAYKEL HEALTHCARE, LTD. CHRIS MANDER
K011485 06/06/2001 PINNACLE MAGNETIC RESONANCE IMAGING SCANNER FONAR CORP. LUCIANO BONANNI
K010122 06/04/2001 CONTINUOUS FLOW Y-TUBING G.U.-TEK ANTHONY SOLAZZO
K010667 06/04/2001 GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R GAMBRO RENAL PRODUCTS JEFFREY R SHIDEMAN
K011624 06/08/2001 EXPEDIO 500D R&F X-RAY SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K011433 06/12/2001 BALLERT CRANIAL MOLDING HELMET GEMA, INC. GENE BERNARDONI
K010301 06/11/2001 IMMUNOWELL EA (D) IGG TEST GENBIO BRYAN KIEHL
K011000 06/29/2001 TRAM 2001 MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K001281 06/12/2001 GERATHERM BABYWATCH TEMPERATURE MONITOR GERATHERM AG ED HOLTER
K011055 06/06/2001 THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS GO MEDICAL INDUSTRIES PTY. LTD. GEORGE O'NEIL
K011699 06/28/2001 VACUETTE EVACUATED BLOOD COLLECTION TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA JUDI SMITH
K010831 06/13/2001 AVIATOR PERIPHERAL DILATATION CATHETER GUIDANT CORP. MERRITT GIRGIS
K011506 06/15/2001 OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORP. CURTIS TRUESDALE
K011384 06/13/2001 HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 HARDY DIAGNOSTICS MELISSA M TRAYLOR, RAC
K002846 06/06/2001 HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR HEADSTAR MEDICAL PRODUCTS CO., LTD
K011413 06/05/2001 POWDER-FREE VINYL EXAM GLOVE, YELLOW HEYUAN HONGLI INDUSTRIES, INC. JANNA TUCKER
K011414 06/05/2001 POWDERED VINAL EXAM GLOVES HEYUAN HONGLI INDUSTRIES, INC. JANNA TUCKER
K011435 06/22/2001 HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM HMT, INC. SEUNG K MO
K010866 06/06/2001 TEMP-A-SURE HOMECARE TECHNOLOGIES LTD. ELI M ORBACH
K003180 06/28/2001 HOMMED OBSERVER, MODEL I HOMMED LLC. TOMMIE J MORGAN
K011623 06/15/2001 EXETER HIP SYSTEM WITH V40 TAPER HOWMEDICA OSTEONICS CORP. NANCY J RIEDER
K011622 06/15/2001 OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K011643 06/28/2001 SCORPIO CR SUPERFLEX TIBIAL INSERT HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K011529 06/12/2001 T2 HUMERAL NAIL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K011125 06/13/2001 NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI HUDSON RESPIRATORY CARE, INC. JEANNIE L DENNING
K011134 06/13/2001 OXYGEN SUPPLY TUBING, MODEL 1115 HUDSON RESPIRATORY CARE, INC. JEANNIE K DENNING
K010875 06/07/2001 HYCARE LATEX EXAMINATION GLOVE, POWDERED HYCARE INTL. CO., LTD. JOHN GRASSI
K011612 06/22/2001 MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM HYDROCISION, INC. DEBBIE IAMPIETRO
K011181 06/25/2001 ICS MEDICAL CHARTR OAE WITH TYMP ICS MEDICAL CORP. DELMAR F BLOEM
K010775 06/12/2001 BIOCELLECT IMTEC CORP. M.K. PATTERSON
K010422 06/28/2001 ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER INNERSPACE, INC. DONALD E BOBO
K003905 06/15/2001 ACTI-ICP MONITORING SYSTEM INNERSPACE, INC. DONALD E BOBO
K010919 06/15/2001 MALE NATURAL RUBBER LATEX CONDOM INNOLATEX SDN. BHD CHANG AH-KAU
K010945 06/12/2001 HEARTCARD, MODEL 5258 INSTROMEDIX ALDEN KAY
K011424 06/25/2001 IL TEST PROS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K011168 06/22/2001 NEUROGEN NERVE GUIDE INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K010193 06/06/2001 HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K011437 06/06/2001 SYNERGY 4.0 MM, 4.5 MM VLS SCREWS INTERPORE CROSS INTL. LYNN RODARTI
K011148 06/13/2001 ULTRACONCENTRATOR SYSTEM INTERPORE CROSS INTL. PROSIE REY-FESSLER
K011616 06/21/2001 INDUO BLOOD GLUCOSE METER INVERNESS MEDICAL INNOVATIONS, INC. CAROL A ADILETTO
K011095 06/13/2001 MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM IODP SA DANIEL KAMM
K010471 06/06/2001 AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 IRVINE BIOMEDICAL, INC. JAMES FARNWORTH
K011598 06/13/2001 WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K010315 06/01/2001 ISCREEN VISION SCREENER ISCREEN, LLC. PETER THRALL
K010951 06/11/2001 ISLAND WOUND DRESSING WITH MICROBAN ISLAND DRESSING, LLC. JOHN A DOBOS
K011490 06/27/2001 MODIFICATION TO EXCITE IVOCLAR NORTH AMERICA, INC. DONNA MARIE HARTNETT
K011331 06/22/2001 JP CAST 40 JENERIC/PENTRON, INC. ANNMARIE TENERO
K011330 06/22/2001 JP CAST 50 JENERIC/PENTRON, INC. ANNMARIE TENERO
K010957 06/25/2001 QUELL DESENSITIZER JENERIC/PENTRON, INC. ANNMARIE TENERO
K010406 06/20/2001 JMS A.V. FISTULA NEEDLE SET "WING EATER", MODEL 14G-18G JMS CO., LTD. KEISUKE URATOMI
K010410 06/20/2001 JMS APHERESIS NEEDLE "WING EATER", MODEL 14G-18G JMS CO., LTD. KEISUKE URATOMI
K010838 06/21/2001 FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 JOMED AG GLENN BYRD
K010987 06/19/2001 KSEA MINIATURE TELESCOPE AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K011359 06/28/2001 MODIFICATION TO KSEA ENDOTIP SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K011860 06/27/2001 KEYST0NE MEDICAL PICC CATHETER KEYSTONE MEDICAL ALAN P SCHWARTZ
K010139 06/29/2001 ZURICH DISTRACTION SYSTEM KLS-MARTIN L.P. ART WARD
K010998 06/27/2001 LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 LANGHAM OPHTHALMIC TECHNOLOGIES MAURICE E LANGHAM
K003538 06/04/2001 TDP CQ-27 HEAT LAMP LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K010049 06/14/2001 PULSECO HEMODYNAMIC MONITOR CM71 LIDCO LTD. GREGORY SPELLER
K010986 06/13/2001 LUNAPADS LUNAPADS INTERNATIONAL PRODUCTS LTD SUZANNE SIEMENS
K011071 06/07/2001 PARADIGM QUICK-SET INFUSION SET MAERSK MEDICAL A/S GERDA RESCH
K010802 06/08/2001 CARDIAC VIEW, MODEL 2001 MAGNA LAB, INC. LYNN CARTER
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K011704 06/27/2001 NPAC EAR THERMOMETER MODEL TD 402 NORM PACIFIC AUTOMATION CORP. CHI-CHU WU CHEN
K011450 06/13/2001 SILICONE IMPRESSION MATERIAL NORTHEAST RESINS & SILICONES, LLC. SIVANANDA S JADA
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K010233 06/22/2001 POWDER FREE NITRILE EXAMINATION GLOVES P.T. HEALTHCARE GLOVINDO ELLEN HUTAPEA
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K003992 06/01/2001 PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM PERCUSURGE, INC. MATTHEW J MOON
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K011619 06/29/2001 PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT PLANMECA OY BOB PIENKOWSKI
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K011270 06/22/2001 AUTOMATED CORE BIOPSY DEVICE PROMEX, INC. JOSEPH L MARK
K010854 06/13/2001 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) PROTECTION GLOVES SDN. BHD. RICHARD CHOOI
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K010916 06/20/2001 PTW DOSIMETRY DIODE, T60008 PTW-NEW YORK CORP. STEPHEN R SZEGLIN
K011486 06/20/2001 Q-RAD RADIOGRAPHIC SYSTEM QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
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K011523 06/14/2001 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K011277 06/26/2001 HARD RELINER S & C POLYMER GMBH JURGEN ENGELBRECHT
K011431 06/11/2001 RESIN CEM S & C POLYMER GMBH CHRISTIAN BOTTCHER
K002543 06/14/2001 COMOACT ULTRASONIC NEBULIZER, MODEL 3060 SAN UP S.A. SUSAN D GOLDSTEIN-FALK
K002427 06/22/2001 SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 SANDHILL SCIENTIFIC, INC. LIUNDA L DIEDERICH
K011001 06/07/2001 TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM SATELEC JEAN-LUC BOULNOIS
K010824 06/05/2001 PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT SCIENCE INCORPORATED LYNN S WEIST
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K011113 06/13/2001 HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) SEBIA BOREK JANIK
K003472 06/04/2001 INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM SEQUAL TECHNOLOGIES, INC. RON HALL
K011371 06/07/2001 NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW SGMP CO., LTD. JANNA P TUCKER
K011370 06/07/2001 NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG SGMP CO., LTD. JANNA P TUCKER
K011377 06/07/2001 NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 SGMP CO., LTD. JANNA P TUCKER
K011364 06/07/2001 CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) SIEMENS HEARING INSTRUMENTS, INC. DAVE SLAVIN
K011366 06/01/2001 CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) SIEMENS HEARING INSTRUMENTS, INC. DAVE SLAVIN
K010938 06/26/2001 SYNGO MULTIMODALITY WORKSTATION SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
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K011299 06/27/2001 SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR SMITH & NEPHEW, INC. TIM CRABTREE
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K011528 06/06/2001 EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 SYVA CO. SUSAN COLLINS
K011620 06/18/2001 EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 SYVA CO., DADE BEHRING, INC. CYNTHIA ARREDONDO
K011605 06/12/2001 EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K011701 06/22/2001 BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD. JEN KE-MIN
K011018 06/22/2001 TAUT BALLOON CATHETER, MODEL 50640 TAUT, INC. RON KENSETH
K002405 06/01/2001 SPINAL EPIDURAL NEEDLES TE ME NA S.A.R.L. ART WARD
K011396 06/18/2001 IBD-CHEK TECHLAB, INC. DAVID M LYERLY
K010239 06/25/2001 COCAINE DIPSTICK TEST, MODEL D747-A TECO DIAGNOSTICS DINDO CARRILLO
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K010669 06/04/2001 NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 THURIS CORP. GRACE BARTOO
K011567 06/19/2001 TORNIER TOTAL ELBOW PROSTHESIS TORNIER IRENE GOSSET
K010545 06/06/2001 TBW TRI-MED, INC. ROBERT J MEDOFF
K011693 06/13/2001 TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 TRUMPF MEDICAL SYSTEMS, INC. WILLIAM APPERSON
K011563 06/05/2001 POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM U.O.P. RUBBER PRODUCTS SDN BHD CHUA BENG CHUAN
K011464 06/13/2001 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN VASCULAR INTERVENTION JENNIFER PAE RIGGS
K010937 06/25/2001 SEP-10S PLUS, AND SP-12S PRO. VILTECHMEDA KOBY BEN-BARAK
K011061 06/28/2001 SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 W & H DENTALWERK BUERMOOS GMBH HERBERT TRASCHWANDTNER
K010326 06/25/2001 WAKO AUTOKIT C3 WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010325 06/25/2001 WAKO AUTOKIT C4 WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010334 06/25/2001 WAKO LIPID CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010186 06/08/2001 WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM WELCH ALLYN, INC. DAVID A YOUNG II
K002727 06/13/2001 YOUNG-HEALTH SUPER EAR THERMOMETER YOUNG HEALTH IND. CO., LTD. YANG RONK-JEH
K011292 06/20/2001 ZIEHM VISION ZIEHM INTERNATIONAL, INC. LANELL SAMANIEGO


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