FDA 510(k) Decisions During September, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K012290 09/28/2001 RAPIDIA 3D MED CO., LTD. CYNTHIA J.M. NOLTE
K011929 09/18/2001 HANDPIECE SHEATH-MODEL #A910 AARON MEDICAL, INC. RICHARD KOZLOFF
K012934 09/28/2001 CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE ABBOTT LABORATORIES JOHN DEAN
K012106 09/25/2001 ACCUIMAGE SMARTGATE UPGRADE ACCUIMAGE DIAGNOSTICS CORP. GARY J ALLSEBROOK
K012300 09/17/2001 ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K012116 09/12/2001 ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING ACRYMED, INC. BRUCE GIBBINS
K011242 09/11/2001 HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE ACUSUPPLY, INC. FERES DAGER
K012168 09/18/2001 ADVANCE MEDICAL DESIGNS FLUID POUCH ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K012190 09/24/2001 AOS MODULAR FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. GARY SOHNGEN
K012201 09/19/2001 PREMICRON NONABSORBABLE PET SURGICAL SUTURE AESCULAP, INC. STEVE REITZLER
K012093 09/21/2001 AETMED IMAGE PROCESSING SOFTWARE AETMED, S.P.A. COLLEEN HITTLE
K012010 09/20/2001 MODIFICATION TO LR 5200 FILM RECORDER AGFA CORP. T.WHIT ATHEY
K013138 09/28/2001 ADC COMPACT PLUS AGFA-GEVAERT AG T. WHIT ATHEY
K010949 09/28/2001 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K012984 09/24/2001 BREATHABLE IMPERVIOUS GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K012149 09/24/2001 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K012386 09/14/2001 ACTICLOT PROTEIN S, MODEL 843L AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K012342 09/05/2001 AMS SOFT-TISSUE APPROXIMATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K010849 09/14/2001 VERTEX ETCHANT APEX DENTAL MATERIALS, INC. SCOTT LAMERAND
K012103 09/14/2001 BANDVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD. SHOSHANA FRIEDMAN
K010592 09/28/2001 AQUA WATER TREATMENT FOR HEMODIALYSIS AQUA WATER TREATMENT, INC. ANTHONY WEATHERS
K004023 09/21/2001 INTRA OPERATIVE RADIATION THERAPY ARPLAY MEDICAL S.A. RICHARD BORGI
K003988 09/06/2001 UROSCOPE, ARTES MEDICAL, USA ARTES MEDICAL USA, INC. WILLIAM KIRKPATRICK
K010303 09/11/2001 ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE ARTSCAN MEDICAL INNOVATIONS ROBERT ANTHONY
K010844 09/21/2001 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K ASTORIA-PACIFIC,INC. RAYMOND L PAVITT
K012154 09/19/2001 AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE AURORA IMAGING TECHNOLOGY, INC. JAMES J ROGERS
K011674 09/04/2001 DC - CRISTAL AUSTENAL, INC. RONALD DUDEK
K012136 09/10/2001 AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER AVITA CORPORATION ALLEN REICH
K011975 09/19/2001 HORIZON OUTLOOK WITH DOSECOM B. BRAUN MEDICAL, INC. LINDA MORGAN
K012205 09/12/2001 GLUCOMETER DEX TEST SENSOR BAYER CORP. GEORGE M TANCOS
K012904 09/21/2001 ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K012584 09/06/2001 MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT BD PASQUALE AMATO
K012208 09/07/2001 ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 BECKMAN COULTER, INC. DENISE THOMPSON
K012351 09/18/2001 BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY BECTON DICKINSON & CO. COLLEEN A ROHRBECK
K012899 09/18/2001 GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE BEST MANUFACTURING COMPANY DAVID C YOUNG
K012084 09/26/2001 SONOREAL 3D BIO MEDI COM COLLEEN HITTLE
K010335 09/27/2001 SLENDERTONE FLEX, MODEL, 512 BIO-MEDICAL RESEARCH, LTD. ROBERT DORMER
K012656 09/06/2001 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 BIO-RAD MARIA ZEBALLOS
K012741 09/12/2001 LIQUICHEK TDM CONTROL BIO-RAD MARIA ZEBALLOS
K012722 09/18/2001 LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 BIO-RAD MARIA ZEBALLOS
K010749 09/28/2001 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL "NMS-DIGITAL" BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K010657 09/14/2001 COPELAND MB RESURFACING HUMERAL HEADS BIOMET MANUFACTURING, INC. SARA A BAILEY
K010827 09/14/2001 COPELAND MB/HA RESURFACING HUMERAL HEADS BIOMET ORTHOPEDICS, INC. SARA A BAILEY
K012334 09/19/2001 CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 BIONX IMPLANTS, INC. TUIJA ANNALA
K011970 09/26/2001 BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K012526 09/14/2001 BIOTEQUE SCALP VEIN SET BIOTEQUE CORP. ALLEN REICH
K012180 09/05/2001 A-WEAR BISCO, INC. STEVEN J DURAY
K012032 09/17/2001 FIRST SPEP BISCO, INC. KATHY LONG
K010882 09/28/2001 BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO ALBERT ZICKMANN
K011664 09/07/2001 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC/MEDI-TECH JODI L GREENIZEN
K012564 09/06/2001 MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM BRAINLAB AG STEFAN VILSMEIER
K010602 09/12/2001 VECTORVISION HIP BRAINLAB, AG RAINER BIRKENBACH
K010612 09/06/2001 VECTORVISION KNEE BRAINLAB, AG RAINER BIRKENBACH
K012541 09/04/2001 MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET BRANAN MEDICAL CORP. RAPHAEL WONG
K010935 09/05/2001 BRITESMILE BARRIER MATERIAL BRITESMILE, INC. SHEILA HEMEON-HEYER
K012913 09/28/2001 BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. BARD, INC. CAROL VIERLING
K012902 09/10/2001 POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 C.R. BARD, INC. STEPHANIE A ERSKINE
K012223 09/10/2001 CG-2211 SELFCHECK ECG TRANSMITTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K011988 09/20/2001 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C CARDIOFOCUS, INC. JOSEPH CURTIS
K011877 09/26/2001 FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM CARL ZEISS JENA GMBH JOHNATHAN S KAHAN
K011361 09/06/2001 DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE CATHEFFECTS, LLC. SHAWN FOJTIK
K012298 09/26/2001 THE INTUITIVE COLORIMETER CERIUM OPTICAL TECHNOLOGIES, INC. SOL AISENBERG
K001687 09/13/2001 COLORMATE TLC BILITEST SYSTEM CHROMATICS COLOR SCIENCES INTL., INC. THOMAS M TSAKERIS
K012157 09/11/2001 CHURCHILL MEDICAL SYSTEMS STOPCOCK CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K011888 09/10/2001 PRESSURE ACTIVATED CHECK VALVE CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K011848 09/11/2001 CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE CIRCON VIDEO JERRY CROUTHERS
K012153 09/19/2001 LOWSLEY SUPRAPUBIC TRACTOR CIRCON VIDEO WAYNE B STGRNER
K012907 09/28/2001 LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL CLINICAL CONTROLS JAMES F GODFREY
K012898 09/17/2001 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K012814 09/21/2001 COLLAGEN NERVE CUFF COLLAGEN MATRIX, INC. SHU-TUNG LI
K010450 09/06/2001 LIVER TAMPONADE BALLOON COOK, INC. LISA HOPKINS
K012590 09/07/2001 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035" DELIVERY SYSTEM CORDIS CORP. CHARLES (CHUCK) J RYAN
K013079 09/28/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT CORGENIX, INC. NANCI DEXTER
K013080 09/28/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT CORGENIX, INC. NANCI DEXTER
K013077 09/28/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT CORGENIX, INC. NANCI DEXTER
K013018 09/20/2001 REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K010621 09/04/2001 ACCU-SPACE ABSORBABLE SEEDING SPACERS CP MEDICAL MARY ANN GREENAWALT
K011828 09/07/2001 CYNOSURE ACCLAIM DERMATOLOGY LASER CYNOSURE, INC. GEORGE CHO
K012470 09/28/2001 MODIFICATION TO N PROTEIN STANDARD SL DADE BEHRING, INC. REBECCA S AYASH
K012468 09/04/2001 MODIFICATION TO N/T PROTEIN CONTROL SL DADE BEHRING, INC. REBECCA S AYASH
K012233 09/11/2001 STRATUS CS TROPONIN I CALIBRATOR DADE BEHRING, INC. ELAINE H KINDELL
K012837 09/14/2001 MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K011868 09/04/2001 ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS DEBIOTECH S.A. SEAN CURRY
K011810 09/07/2001 ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING DEPUY, INC. JANET G JOHNSON
K012301 09/19/2001 IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012797 09/28/2001 DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012795 09/28/2001 DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K010619 09/28/2001 UCLA AND UNIVERSAL ABUTMENTS DIAMODENT JEFF RASSOLI
K010478 09/27/2001 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR DIDECO LYNNE LEONARD
K010892 09/24/2001 MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 DIGENE CORP. MARK A DEL VECCHIO
K010893 09/24/2001 MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 DIGENE CORP. MARK A DEL VECCHIO
K010891 09/25/2001 MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 DIGENE CORP. MARK A DEL VECCHIO
K012177 09/04/2001 VENTVIEW, MODEL 8414095 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K012152 09/18/2001 DS30 HCY BLOOD COLLECTION TUBES DREW SCIENTIFIC LTD. ANDREW KENNEY
K011898 09/14/2001 E-STETH ELECTRONIC STETHOSCOPE E-MED INNOVATIONS, INC. HUGH E HACKNEY
K012079 09/19/2001 GEODESIC EEG SYSTEM, MODEL 200 ELECTRICAL GEODESICS, INCORPORATED ROBERT S MCQUATE
K012926 09/28/2001 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. ERIC W KOEHLER
K012306 09/21/2001 AUDIOSCAN VERIFIT, MODEL VF-1 ETYMONIC DESIGN, INC. WILLIAM A COLE
K011387 09/06/2001 NEUROTHERM, MODEL JK4 EUROLINK LLC. WILLIAM RITTMAN
K011405 09/27/2001 EXEL INJECTION PLUG WITH CAP EXELINT INTL. CO. ARMAND HAMID
K011964 09/20/2001 INSIGHT MILLENNIUM PLUS FASSTECH LEE BRODY
K010750 09/07/2001 PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 FISHER DIAGNOSTICS NADIA GREENIDGE
K012062 09/27/2001 PF2 FIXANO SA FRANK FERGUSON
K012078 09/27/2001 RADIOFIX FIXANO SA FRANK FERGUSON
K012775 09/18/2001 GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER GE MEDICAL SYSTEMS GEOFFREY COCHRANE
K012970 09/24/2001 GE SIGNA ASSET IMAGING OPTION GE MEDICAL SYSTEMS LARRY KROGER
K012836 09/07/2001 MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K012568 09/06/2001 GE VISION NUCLEAR MEDICINE WORKSTATION GENERAL ELECTRIC CO. KEVIN M MURROCK
K012573 09/05/2001 CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC GETINGE/CASTLE, INC. FREDERICK R CATT
K012411 09/25/2001 HP-ONE GI SUPPLY FRANK CARTER
K012043 09/24/2001 VACUETTE EDTA K2 GEL TUBES GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K012050 09/06/2001 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER GUIDANT CORP. SABA MODJARRAD
K010851 09/18/2001 HARRISON HAND HELD ADJUSTING INSTRUMENT HARRISON CBP SEMINARS SANG HARRISON
K012723 09/28/2001 PLATELETWORKS HELENA LABORATORIES PATRICIA FRANKS
K012250 09/24/2001 RAICHEM MULTI-ANALYTE CALIBRATOR HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K011979 09/14/2001 ALLERSHARP ALLERGY SKIN TESTER HMB MEDICAL CONCEPTS, LTD. GAVIN MCLACHLAN
K012870 09/24/2001 XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012008 09/21/2001 STS RANGE , MODELS STS20,STS30,STS40 HUNTLEIGH HEALTHCARE, INC. AUDREY WITKO
K010973 09/11/2001 DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 HYPOGUARD USA, INC. BRUCE MACFARLANE
K012047 09/19/2001 3I CALCIUM SULFATE BONE CEMENT IMPLANT INNOVATIONS, INC. MARY L VERSTYNEN
K012911 09/28/2001 3I LOCATER ABUTMENT SYSTEM IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K012866 09/26/2001 THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 IMPLEX CORP. ROBERT A POGGIE
K012901 09/27/2001 COLOR-MONOGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K012768 09/18/2001 HEMOSIL RECOMBI PLASTIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K012871 09/13/2001 SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 INTERPORE CROSS INTL. LYNN M RODARTI
K012927 09/19/2001 M71 POWER WHEELCHAIR INVACARE CORP. RAE ANN FARROW
K012332 09/06/2001 JAS CARBON DIOXIDE LIQUID REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K002352 09/06/2001 JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE JMS CO., LTD. KEISUKE URATOMI
K002394 09/05/2001 JMS APHERESIS NEEDLE SET ACCORDION TYPE JMS CO., LTD. KEISUKE URATOMI
K012124 09/19/2001 MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP JOHNSON & JOHNSON MEDICAL (CHINA) LTD. BEN TANG
K011841 09/10/2001 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY JAMES A LEE
K011943 09/19/2001 IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR KENSEY NASH CORP. JULIE N BRODERICK
K011908 09/06/2001 OPTIBOND SOLO PLUS 3 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K012730 09/13/2001 CLEARFIL PORCELAIN BOND ACTIVATOR KURARAY MEDICAL INC. MASAYA SASAKI
K012733 09/14/2001 CARIES DETECTOR KURARAY MEDICAL INC. MASAYA SASAKI
K012737 09/14/2001 CHROMA ZONE COLOR STAIN KURARAY MEDICAL INC. MASAYA SASAKI
K012740 09/14/2001 CLEARFIL AP-X KURARAY MEDICAL INC. MASAYA SASAKI
K012703 09/10/2001 CLEARFIL CORE NEW BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012735 09/14/2001 CLEARFIL DC CEMENT KURARAY MEDICAL INC. MASAYA SASAKI
K012734 09/14/2001 CLEARFIL NEW BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012705 09/11/2001 CLEARFIL PHOTO CORE KURARAY MEDICAL INC. MASAYA SASAKI
K012729 09/13/2001 CLEARFIL REPAIR KURARAY MEDICAL INC. MASAYA SASAKI
K012704 09/10/2001 CLEARFIL ST OPAQUER KURARAY MEDICAL INC. MASAYA SASAKI
K012707 09/13/2001 ESTENIA KURARAY MEDICAL INC. MASAYA SASAKI
K012436 09/04/2001 MODIFICATION TO ALLOY PRIMER KURARAY MEDICAL INC. MASAYA SASAKI
K012440 09/05/2001 MODIFICATION TO CLEARFIL LINER BOND 2V KURARAY MEDICAL INC. MASAYA SASAKI
K012432 09/04/2001 MODIFICATION TO CLEARFIL PHOTO BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012442 09/10/2001 MODIFICATION TO CLEARFIL SE BOND KURARAY MEDICAL INC. MASAYA SASAKI
K012438 09/05/2001 MODIFICATION TO PANAVIA 21 KURARAY MEDICAL INC. MASAYA SASAKI
K012441 09/06/2001 PANAVIA F KURARAY MEDICAL INC. MASAYA SASAKI
K012742 09/14/2001 TEETHMATE F-1 KURARAY MEDICAL INC. MASAYA SASAKI
K010431 09/06/2001 LEAD-LOK REUSABLE TENS/ NMES ELECTRODES LEAD-LOK, INC. CHRIS HEALY
K011340 09/21/2001 LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT LH MEDICAL PRODUCTS, INC. LONNIE HUTSON
K011343 09/21/2001 LH 500 ENTERAL FEEDING GRAVITY BAG SET LH MEDICAL PRODUCTS, INC. LONNIE HUTSON
K011341 09/21/2001 LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET LH MEDICAL PRODUCTS, INC. LONNIE HUTSON
K003191 09/28/2001 MIS IMPLANT SYSTEM DECIVE M.I.S. IMPLANTS TECHNOLOGIES LTD. AHAVA STEIN
K012413 09/18/2001 MACROPORE FX, PS, NS, LP MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K011785 09/04/2001 NOVEL PRINT CYAN ALGINATES MANUFACTURERA DENTAL CONTINENTAL GARY S MOCNIK
K012009 09/13/2001 MX8000 IDT CT SYSTEM MARCONI MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K012558 09/17/2001 POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS MATANG MFG. SDN. BHD. KOK-KEE HON
K011790 09/05/2001 MICROCRUISER PLUS INTRODUCER SET MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K012352 09/21/2001 SQA, SPERM QUALITY ANALYZER MEDICAL ELECTRONIC SYSTEMS, LLC ERIKA B AMMIRATI
K012030 09/24/2001 PORTABLE INTENSIVE CARE UNIT MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K012887 09/12/2001 SA6000II DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K012867 09/12/2001 SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K011240 09/13/2001 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC. STACEY L BOLEN
K010981 09/20/2001 GSA GENITO SENSORY ANALYZER MEDOC LTD. ADVANCED MEDICAL SYSTEMS ANN QUINLAN-SMITH
K013084 09/27/2001 AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K012747 09/14/2001 TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K012743 09/14/2001 TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K012428 09/28/2001 MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K003780 09/28/2001 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K012802 09/18/2001 MP3CF ELECTRIC WHEELCHAIR MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K011981 09/05/2001 MHS 5000 MICRO HEALTH SYSTEMS INC. ROBERT BARNES
K012540 09/26/2001 BLY-501 ADAPTOR MICROMEDICAL INDUSTRIES, LTD. STEPHEN CRESSWELL
K010712 09/27/2001 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES MOLDED PRODUCTS INC. ELISE JOHNSTON
K012939 09/28/2001 AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER MONAGHAN MEDICAL CORP. JAMES A COCHIE
K011816 09/07/2001 MINI MULTILEAF COLLIMATOR, MODEL KMI MRC SYSTEMS GMBH JORG STEIN
K013099 09/25/2001 MODIFICATION TO: QWH-420 WRIST ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K011926 09/11/2001 ELEC-MATE E NAKANISHI, INC. HIROJI SEKIGUCHI
K012262 09/12/2001 BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012259 09/12/2001 MEDFUSION 2001 & 2010, MODEL N7215IWC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012229 09/10/2001 SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012266 09/12/2001 SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 NATIONAL CUSTOM ENT., INC. DON PELLETIER
K011820 09/05/2001 DENTORIUM CONVERTIBLE ACRYLIC NATS CORP. RICHARD C LANZILLOTTO
K000122 09/20/2001 COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) NEUCOLL, INC. ANNE WORDEN
K011241 09/19/2001 NEUROSOFT'S SOURCE NEUROSOFT, INC. ELVIRA GARCIA
K011821 09/06/2001 MODIFICATION TO THE I.C.O.S SCREW NEWDEAL S.A. NORMAN F ESTRIN
K011875 09/06/2001 MODIFICATION TO THE TAC' PIN NEWDEAL S.A. MORGANE GRENIER
K010424 09/04/2001 NEXAN SYSTEM, MODEL NX-301 NEXAN LTD DAVID L WEST
K011128 09/06/2001 NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K011823 09/06/2001 BIOREHAB SYSTEM NICOLET BIOMEDICAL, INC. GARY J SYRING
K011818 09/06/2001 STERILE EMG ELECTRODES NICOLET BIOMEDICAL, INC. GARY SYRING
K011918 09/12/2001 NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
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K012082 09/20/2001 OPTIBOND SOLO PLUS ACTIVATOR SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K011857 09/12/2001 SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM SYNTHES (USA) BONNIE J SMITH
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K011434 09/18/2001 G7 AUTOMATED HPLC ANALYZER TOSOH MEDICS, INC. LOIS NAKAYAMA
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K012539 09/06/2001 VERASTEP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHESTER MCCOY
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K011800 09/27/2001 VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
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