FDA 510(k) Applications Received During August, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K012472 08/02/2001 A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. JERRY WANG
K012934 08/31/2001 CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE ABBOTT LABORATORIES JOHN DEAN
K012701 08/14/2001 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) ACCUMETRICS, INC. RHONDA MOE
K012824 08/23/2001 ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K012595 08/10/2001 ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K012655 08/13/2001 CONGRUENT BONE PLATE SYSTEM ACUMED, INC. SHARI JEFFERS
K012693 08/14/2001 MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES ACUTRONIC MEDICAL SYSTEMS AG TERRY TORZALA
K012691 08/14/2001 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES ACUTRONIC MEDICAL SYSTEMS AG TERRY TORZALA
K012534 08/06/2001 HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING ADVANCED CARDIOVASCULAR SYSTEMS, INC. JOANNA MROZ
K012928 08/31/2001 ABI VEST AIRWAY CLEARANCE SYSTEM ADVANCED RESPIRATORY ERIC J LARSON
K012694 08/14/2001 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS ADVEN MEDICAL MARK W ALDANA
K012675 08/14/2001 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS ADVEN MEDICAL MARK W ALDANA
K012676 08/14/2001 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS ADVEN MEDICAL MARK W ALDANA
K012750 08/16/2001 ADC PEDIATRIC AGFA CORP. T. WHIT ATHEY
K012941 08/31/2001 DRYSTAR, MODEL 4500M AGFA CORP. T. WHIT ATHEY
K012931 08/31/2001 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM ALLEGIANCE HEALTHCARE CORP. LANCE MARCONI
K012708 08/14/2001 ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. DON SELVEY
K012605 08/13/2001 REPROCESSED ATHROSCOPICS BURS ALLIANCE MEDICAL CORP. DON SELVEY
K012603 08/13/2001 REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS ALLIANCE MEDICAL CORP. DON SELVEY
K012652 08/13/2001 REPROCESSED DYONICS ARTHROSCOPIC BURS ALLIANCE MEDICAL CORP. DON SELVEY
K012645 08/13/2001 REPROCESSED EBI EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. DON SELVEY
K012623 08/13/2001 REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL CORP. DON SELVEY
K012648 08/13/2001 REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. DON SELVEY
K012631 08/13/2001 REPROCESSED SOFT TISSUE ABLATORS ALLIANCE MEDICAL CORP. DON SELVEY
K012635 08/13/2001 REPROCESSED STRYKER ARTHROSCOPIC SHAVERS ALLIANCE MEDICAL CORP. DON SELVEY
K012625 08/13/2001 REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS ALLIANCE MEDICAL CORP. DON SELVEY
K012611 08/13/2001 REPROCESSED DYONICS ARTHROSCOPIC SHAVERS ALLIANCE MEDICAL, INC. DON SELVEY
K012634 08/13/2001 REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL, INC. DON SELVEY
K012630 08/13/2001 REPROCESSED LINVATEC ARTHROSCOPIC BURS ALLIANCE MEDICAL, INC. DON SELVEY
K012613 08/13/2001 REPROCSSED LINVATEC SHAVERS ALLIANCE MEDICAL, INC. DON SELVEY
K012484 08/02/2001 AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE AMEDITECH, INC. JOHN WU
K012585 08/10/2001 AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE AMEDITECH, INC. JOHN WU
K012483 08/02/2001 AMEDITECH IMMUTEST DRUG SCREEN OPIATES AMEDITECH, INC. JOHN WU
K012582 08/10/2001 AMEDITECH IMMUTEST DRUG SCREEN PCP AMEDITECH, INC. JOHN WU
K012576 08/09/2001 CIC-C1Q EIA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD E CONLEY
K012796 08/21/2001 AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 AMLUCK, INC. YANG TIEN-HSING
K012464 08/01/2001 HELIX HYDRO-JET ANDREAS PEIN MEDIZINTECHNIK GMBH ROBERT N CLARK
K012754 08/16/2001 EZ SET INFUSION SET ANIMAS CORP. MICHAEL J ANDREWS
K012643 08/13/2001 APEX MEDICAL LCD TENS-VII APEX MEDICAL CORP. ALAN CHANG
K012918 08/30/2001 APEX MODULAR ALUMINA FEMORAL HEAD APEX SURGICAL, LLC. EDWARD J CHEAL
K012884 08/28/2001 DILATING TIP OBTURATOR APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K012476 08/02/2001 MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 APPLIED MEDICAL TECHNOLOGY, INC. CHRIS ZANTOPULOS
K012489 08/03/2001 MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 APPRIVA MEDICAL, INC. MICHAEL KOLBER
K012923 08/31/2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC. ANN WATERHOUSE
K012519 08/06/2001 ARTHROCARE ELECTROSURGERY WANDS ARTHROCARE CORP. BRUCE PROTHRO
K012872 08/27/2001 RESORBABLE SCREW ANCHOR ARTHROTEK, INC. SARA B SHULTZ
K012487 08/02/2001 SPHYGMOCOR PX MODEL SCOR-PX ATCOR MEDICAL PTY. LTD KIRSTEN PAULSON
K012873 08/27/2001 DOCUMENTING LASER SLIT LAMP, DP 2010 BAUSCH & LOMB, INC. PENNI L PANNELL
K012777 08/20/2001 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS BAYER CORP. KENNETH T EDDS
K012904 08/29/2001 ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K012584 08/10/2001 MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT BD PASQUALE AMATO
K012900 08/29/2001 ACCESS UNCONJUGATED ESTRIOL CALIBRATORS BECKMAN COULTER, INC. MARA CALER
K012746 08/16/2001 ICE BATON BEHIVE LTD MARY MCNAMARA-CULLINANE
K012899 08/29/2001 GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE BEST MANUFACTURING COMPANY DAVID C YOUNG
K012521 08/06/2001 BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST BINAX, INC. PAMELA ANGELL
K012656 08/13/2001 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 BIO-RAD MARIA ZEBALLOS
K012513 08/06/2001 LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 BIO-RAD MARIA ZEBALLOS
K012741 08/16/2001 LIQUICHEK TDM CONTROL BIO-RAD MARIA ZEBALLOS
K012722 08/15/2001 LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 BIO-RAD MARIA ZEBALLOS
K012749 08/16/2001 BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 BIOCARDIA, INC. DANIEL C ROSENMAN
K012829 08/23/2001 STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS BIOCARE CORP. BRUCE A MACFARLAND
K012511 08/06/2001 WATERLASE MILLENNIUM BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K012503 08/03/2001 METAL SCREW ANCHOR BIOMET MANUFACTURING, INC. SARA B SHULTZ
K012469 08/02/2001 RESORBABLE NO PROFILE SCREW AND WASHER BIOMET MANUFACTURING, INC. SARA B SHULTZ
K012798 08/21/2001 INTEX SCREW BIOMET, INC. DALENE T BINKLEY
K012551 08/07/2001 LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC. PATRICIA SANDBORN BERES
K012569 08/09/2001 MODIFICATION TO: INJECTABLE MIMIX BIOMET, INC. SARA B SHULTZ
K012572 08/09/2001 SOFT TISSUE SCREW AND WASHER BIOMET, INC. SARA B SHULTZ
K012559 08/08/2001 POLY STAT HCG TEST BION DIAGNOSTIC SCIENCES HELEN LANDICHO
K012908 08/30/2001 BIOPLATE RESORBABLE BONE SCREW BIOPLATE, INC. ERIC V HOHENSTEIN
K012910 08/30/2001 THE BIOPLATE MANDIBLE FIXATION SYSTEM BIOPLATE, INC. BRUCE F MACKLER
K012745 08/16/2001 TRIAGE TOX DRUG SCREEN, CATALOG #94000 BIOSITE INCORPORATED JEFFREY R DAHLEN
K012728 08/15/2001 E-SCAN MRI SYSTEM BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K012526 08/06/2001 BIOTEQUE SCALP VEIN SET BIOTEQUE CORP. ALLEN REICH
K012465 08/01/2001 MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR BONUTTI RESEARCH, INC. PATRICK BALSMANN
K012864 08/27/2001 INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K012883 08/28/2001 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K012752 08/16/2001 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K012822 08/23/2001 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX BOSTON SCIENTIFIC SCIMED, INC. TODD KORNMANN
K012564 08/09/2001 MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM BRAINLAB AG STEFAN VILSMEIER
K012448 08/01/2001 VECTORVISION TRAUMA BRAINLAB AG RAINER BIRKENBACH
K012541 08/07/2001 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
K012913 08/30/2001 BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. BARD, INC. CAROL VIERLING
K012902 08/29/2001 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
K012686 08/14/2001 CAIRD TECHNOLOGY HOLTER 2000 CAIRD TECHNOLOGY JAMES H BROWN
K012520 08/06/2001 GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E CARDIAC ASSIST DEVICES, INC. RASSOLL RASHIDI
K012727 08/15/2001 HUMPHREY OCT3 CARL ZEISS OPHTHALMIC SYSTEMS, INC. MELISSSA R HORNE
K012886 08/28/2001 CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE CBYON, INC. KRISHNA SUDHAKARAN
K012446 08/01/2001 OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI CHARLES A. SMITH CHARLES A SMITH
K012731 08/15/2001 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K012925 08/31/2001 DUR-8, MODELS DUR-8 CIRCON VIDEO WAYNE STERNER
K012929 08/31/2001 FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 CIRCON VIDEO WAYNE STERNER
K012758 08/17/2001 URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, CIRCON VIDEO WAYNE STERNER
K012942 08/31/2001 THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K012601 08/13/2001 CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH CLEAR MEDICAL, INC. RICHARD RADFORD
K012621 08/13/2001 CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT CLEAR MEDICAL, INC. RICHARD RADFORD
K012616 08/13/2001 CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR CLEAR MEDICAL, INC. RICHARD RADFORD
K012606 08/13/2001 CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE CLEAR MEDICAL, INC. RICHARD RADFORD
K012600 08/13/2001 CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L CLEAR MEDICAL, INC. RICHARD RADFORD
K012609 08/13/2001 CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 CLEAR MEDICAL, INC. RICHARD RADFORD
K012622 08/13/2001 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 CLEAR MEDICAL, INC. RICHARD RADFORD
K012612 08/13/2001 CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE CLEAR MEDICAL, INC. RICHARD RADFORD
K012907 08/29/2001 LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL CLINICAL CONTROLS JAMES F GODFREY
K012855 08/24/2001 LIQUISPX LIQUID LIPID CONTROL CLINICAL CONTROLS DIVISION JAMES F GODFREY
K012898 08/29/2001 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K012763 08/17/2001 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K012814 08/22/2001 COLLAGEN NERVE CUFF COLLAGEN MATRIX, INC. SHU-TUNG LI
K012590 08/10/2001 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM CORDIS CORP. CHARLES (CHUCK) J RYAN
K012567 08/09/2001 MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K012563 08/09/2001 DEEP GRAY CORTECHS LABS, INC. JEFFREY M ANDERS
K012602 08/13/2001 CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX CROSSTEX INTL. SUSAN D GOLDSTEIN-FALK
K012790 08/20/2001 CYNOSURE PHOTOGENICA ER CYNOSURE, INC. GEORGE CHO
K012806 08/21/2001 CYNOSURE PHOTOGENICA VL CYNOSURE, INC. GEORGE CHO
K012470 08/02/2001 MODIFICATION TO N PROTEIN STANDARD SL DADE BEHRING, INC. REBECCA S AYASH
K012468 08/02/2001 MODIFICATION TO N/T PROTEIN CONTROL SL DADE BEHRING, INC. REBECCA S AYASH
K012885 08/28/2001 NEUROMOVE NM900 DAN MED, INC. THOMAS SANDGAARD
K012531 08/06/2001 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX DATEX-OHMEDA JOEL KENT
K012837 08/23/2001 MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K012924 08/31/2001 DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER DATEX-OHMEDA, INC. BILL EXNER
K012681 08/14/2001 ANKYLOS DENTSPLY CERAMCO THOMAS B CAMERON
K012720 08/15/2001 TULSA CONTRA ANGLES DENTSPLY INTL. P. JEFFREY LEHN
K012773 08/20/2001 DISCOVERY FACET SCREW FIXATION SYSTEM DEPUY ACROMED KAREN F JURCZAK
K012738 08/16/2001 SYMPHONY GRAFT DELIVERY SYSTEM (GDS) DEPUY ACROMED KAREN F JURCZAK
K012916 08/30/2001 FRONTIER ANTERIOR SCOLIOSIS SYSTEM DEPUY ACROMED, INC. LISA GILMAN
K012547 08/07/2001 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION DI-CHEM, INC. KEITH A BUCHHOLZ
K012450 08/01/2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012449 08/01/2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012797 08/21/2001 DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012795 08/21/2001 DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012535 08/07/2001 DRG DISPOSABLE VAGINAL SPECULUM DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K012821 08/23/2001 D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM DUTCH OPHTHALMIC USA, INC. MARK W FURLONG
K012816 08/22/2001 DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 DYNAREX CORP. JOHN GAGLIARDI
K012917 08/30/2001 DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B DYNAREX CORP. JOHN GAGLIARDI
K012516 08/06/2001 EBI SPINELINK - II SPINAL FIXATION SYSTEM EBI, L.P. PATRICIA M FLOOD
K012474 08/02/2001 ATAC PAK CPK REAGENT KIT ELAN HOLDINGS, INC. WYNN STOCKING
K012445 08/01/2001 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) ELECTRO MEDICAL SYSTEMS SA SHEILA HEMEON-HEYER
K012906 08/29/2001 ANIMEC, MODELS AM-2S-4 AND AM-2S-5 ELLTEC CO., LTD. GENSHIRO OGAWA
K012488 08/03/2001 MODIFICATION TO:ENDIUS BIPOLAR SHEATH ENDIUS, INC. SUSAN FINNERAN
K012725 08/15/2001 TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES ENDO-THERAPEUTICS, INC. TODD ADKISSON
K012926 08/31/2001 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. ERIC W KOEHLER
K012702 08/14/2001 BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 ENDOTEC, INC. ALEX CANONACO
K012463 08/01/2001 LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K012493 08/03/2001 ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 EXACTECH, INC. ROBERT PAXSON
K012879 08/28/2001 EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE EXELINT INTL. CO. ARMAND HAMID
K012920 08/30/2001 MOLDED CRANIAL HELMET FAIRVIEW ORTHOPEDIC LABORATORY ROSS C D'EMANUELE
K012641 08/13/2001 FAS ENDOLUMINAL BRUSH FAS MEDICAL LTD. THOMAS KROENKE
K012497 08/03/2001 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 GALIL MEDICAL LTD. JONATHAN S KAHAN
K012542 08/07/2001 REVOTEK LC GC AMERICA, INC. TERRY L JORITZ
K012775 08/20/2001 GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER GE MEDICAL SYSTEMS GEOFFREY COCHRANE
K012836 08/23/2001 MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K012875 08/27/2001 SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS LARRY KROGER
K012915 08/30/2001 DINAMAP PRO 1000 MONITOR, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES THOMAS J ENGLISH
K012718 08/15/2001 MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOELLE NEIDER
K012560 08/08/2001 GE LOGIQ A100 MP, MODEL 2272413 GENERAL ELECTRIC CO. ALLEN SCHUH
K012568 08/09/2001 GE VISION NUCLEAR MEDICINE WORKSTATION GENERAL ELECTRIC CO. KEVIN M MURROCK
K012466 08/01/2001 BIS/EEG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K012467 08/01/2001 SOLAR 8000M SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K012532 08/06/2001 SEPRAGEL SINUS GENZYME CORP. NANCY A IMMEL
K012573 08/09/2001 CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC GETINGE/CASTLE, INC. FREDERICK R CATT
K012869 08/27/2001 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 GIMMI GMBH DAGMAR MASER
K012660 08/13/2001 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES GIMMI GMBH DAGMAR MASER
K012553 08/08/2001 GSIBP BLOOD PRESSURE CUFF GLOBALSHOP, INC. GARY C BAUMAN
K012628 08/13/2001 GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM GYNECARE CENTER GREGORY JONES
K012805 08/21/2001 AUTOMARQER HAMILTON THORNE RESEARCH DIARMAID DOUGLAS-HAMITON
K012785 08/20/2001 TWINTRODE ELC 134 ELECTRODE HEALTH TRONICS SURGICAL SERVICES, INC. PETER WEIMAN
K012549 08/07/2001 ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM HEALTHWAY PRODUCTS, INC. DICK BRIGGS
K012723 08/15/2001 PLATELETWORKS HELENA LABORATORIES PATRICIA FRANKS
K012583 08/10/2001 ACUGLIDE BRAND ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. YI FEN CHANG
K012649 08/13/2001 RAICHEM BUN RATE REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K012668 08/13/2001 RAICHEM GLUCOSE UV REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K012779 08/20/2001 ICONNECTION 3D HINNOVATION, INC. YI ISABELLE SUN
K012914 08/30/2001 SONICWAVE SONIC PLAQUE REMOVER HOMEDICS, INC. DAVID VANDERLIN
K012726 08/15/2001 PROSAFE SAFETY SYRINGE HOU-SE MEDICAL INC JOSEPH J CHANG
K012776 08/20/2001 DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K012870 08/27/2001 XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012811 08/22/2001 BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B HUMAGEN FERTILITY DIAGNOSTICS, INC. CINDY SHOWALTER
K012501 08/03/2001 H.M.T. ACUPUNCTURE NEEDLE HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. GEOFFREY HSU
K012759 08/17/2001 INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 HUTCHINSON TECHNOLOGY, INC. JOSEPH ORTNER
K012654 08/13/2001 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012651 08/13/2001 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012715 08/14/2001 HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II HYGIA HEALTH SERVICES, INC. TRACY COMAS
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K012478 08/02/2001 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER I-STAT CORP. PAUL VANDERWERF
K012719 08/14/2001 NAVIGUS II MR IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K012706 08/14/2001 IM2001 PULSE OXIMETER IMAGYN MEDICAL TECHNOLOGIES, INC. SANDRA COHEN KALTER
K012911 08/30/2001 3I LOCATER ABUTMENT SYSTEM IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K012866 08/27/2001 THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 IMPLEX CORP. ROBERT A POGGIE
K012507 08/06/2001 THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) IMPLEX CORP. ROBERT A POGGIE
K012490 08/03/2001 ORION DIGITAL IMAGING SYSTEM INFIMED, INC. RALPH J FLATAU
K012664 08/13/2001 ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT INNOLATEX SDN. BHD CHANG AH-KAU
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K012901 08/29/2001 COLOR-MONOGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K012768 08/17/2001 HEMOSIL RECOMBI PLASTIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K012871 08/27/2001 SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 INTERPORE CROSS INTL. LYNN M RODARTI
K012833 08/23/2001 INTUITIVE SURGICAL BIPOLAR FORCEPS INTUITIVE SURGICAL, INC. MICHAEL YRAMATEGUI
K012927 08/31/2001 M71 POWER WHEELCHAIR INVACARE CORP. RAE ANN FARROW
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K012502 08/03/2001 MEDIGROUP CATHETER EXTENDER/REPAIR KIT JANIN GROUP, INC. JOHN A NAVIS
K012774 08/20/2001 JOSTRA ARTERIAL PERFUSION CANNULAE JOSTRA AG KATHLEEN JOHNSON
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K012492 08/03/2001 KADANCE 2000 KADA RESEARCH, INC. HARVEY KNAUSS
K012527 08/06/2001 KSEA SIALOENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K012482 08/02/2001 STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION KARL STORZ ENDOSCOPY-AMERICA, INC. JENNIFER PORTUGAL
K012815 08/22/2001 SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE KIMBERLY-CLARK CORP. MARCIA JOHNSON
K012485 08/02/2001 MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE KING SYSTEMS CORP. CHARLES A BURT
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K012733 08/14/2001 CARIES DETECTOR KURARAY MEDICAL INC. MASAYA SASAKI
K012737 08/14/2001 CHROMA ZONE COLOR STAIN KURARAY MEDICAL INC. MASAYA SASAKI
K012740 08/14/2001 CLEARFIL AP-X KURARAY MEDICAL INC. MASAYA SASAKI
K012703 08/14/2001 CLEARFIL CORE NEW BOND KURARAY MEDICAL INC. MASAYA SASAKI
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K012734 08/14/2001 CLEARFIL NEW BOND KURARAY MEDICAL INC. MASAYA SASAKI
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K012730 08/14/2001 CLEARFIL PORCELAIN BOND ACTIVATOR KURARAY MEDICAL INC. MASAYA SASAKI
K012729 08/14/2001 CLEARFIL REPAIR KURARAY MEDICAL INC. MASAYA SASAKI
K012704 08/14/2001 CLEARFIL ST OPAQUER KURARAY MEDICAL INC. MASAYA SASAKI
K012707 08/14/2001 ESTENIA KURARAY MEDICAL INC. MASAYA SASAKI
K012742 08/14/2001 TEETHMATE F-1 KURARAY MEDICAL INC. MASAYA SASAKI
K012830 08/23/2001 LERMAN & SON CRANIAL ORTHOSIS HELMET LERMAN & SON MAX LERMAN
K012825 08/23/2001 HEARTTRENDS LEV-EL, LTD. EINAT SHAMMAI
K012545 08/07/2001 ARAMIS DERMATLOGIC LASER LUMEDICS, LTD. JONATHAN S KAHAN
K012491 08/03/2001 MACHNET CAROTIDS COIL ARRAY ASSEMBLY MACHNET BV DANIEL KAMM
K012769 08/17/2001 MACROPORE ENT RECONSTRUCTION FILM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K012844 08/23/2001 MAROSIS PACS MAROTECH, INC CARL ALLETTO
K012558 08/08/2001 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
K012562 08/08/2001 MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER MEDICAL COMPONENTS, INC. FLORENCE A CAIKOSKI
K012640 08/13/2001 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS MEDICAL INSTRUMENTS TECHNOLOGY, INC. JACK SPEER
K012614 08/13/2001 KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN MEDICAL INSTRUMENTS TECHNOLOGY, INC. JACK SPEER
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K012766 08/17/2001 PORTABLE INTENSIVE CARE UNIT MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K012887 08/28/2001 SA6000II DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K012867 08/27/2001 SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K012747 08/16/2001 TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K012743 08/16/2001 TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K012506 08/06/2001 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE
K012937 08/31/2001 KNEE MODULE FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA G RENDON
K012454 08/01/2001 MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MEDTRONIC VASCULAR TINA BENOIT
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K012460 08/01/2001 MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR TINA BENOIT
K012452 08/01/2001 MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR TINA BENOIT
K012538 08/07/2001 TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE MEDTRONIC VASCULAR MARIE HOLM
K012802 08/21/2001 MP3CF ELECTRIC WHEELCHAIR MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
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K012540 08/07/2001 BLY-501 ADAPTOR MICROMEDICAL INDUSTRIES, LTD. STEPHEN CRESSWELL
K012868 08/27/2001 MICROMEDICS FIBRIJET AEROSOL APPLICATOR MICROMEDICS, INC. CHARLES GROTE
K012939 08/31/2001 AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER MONAGHAN MEDICAL CORP. JAMES A COCHIE
K012789 08/20/2001 MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 MORAX BOREK JANIK
K012522 08/06/2001 WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL NATIONAL THERAPY PRODUCTS INC. PAUL L HOOEY
K012891 08/28/2001 OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) NELLCOR PURITAN BENNETT, INC. RONALD J EHMSEN
K012861 08/24/2001 VASCUPUNCTURE ACCESS WIRE NEO METRICS, INC. GENE CHAMPEAU
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K012823 08/16/2001 MODIFICATION TO HANDMASTER NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS JONATHAN S HAHAN
K012530 08/06/2001 AA-1 SYSTEM NEUROVISION, INC. RICHARD E LIPPMAN
K012712 08/14/2001 NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 NORAV MEDICAL LTD. STEVE SPRINGROSE
K012575 08/09/2001 PREFERNCE IMRT TREATMENT PLANNING MODULE NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K012508 08/06/2001 MU PHOTONICS PAIN THERAPIST NU PHOTONICS, INC. WILLIAM M BROCK
K012832 08/23/2001 COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 NXSTAGE MEDICAL, INC. KAREN ST. ONGE
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K012852 08/24/2001 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS OPTONOL, LTD RICHARD E LIPPMAN
K012751 08/16/2001 HEALOS BONE GRAFT MATERIAL ORQUEST, INC. KRISTINE F LAHMAN
K012561 08/08/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS ORTHO-CLINICAL DIAGNOSTICS SUSAN WERNER WERNER
K012593 08/10/2001 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. MARLENE A SHULMAN
K012533 08/06/2001 MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES OSI MEDICAL, INC. JON WERNER
K012626 08/13/2001 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR OSI MEDICAL, INC. JON WERNER
K012762 08/17/2001 MJS POSTERIOR STABILIZED KNEE SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K012486 08/02/2001 OSTEOMED BIORESORBABLE FIXATION SYSTEM OSTEOMED CORP. DAWN T HOLDEMAN
K012588 08/10/2001 OXOID PYLORI TEST KIT, MODEL DR0130M OXOID, LTD. ANDY HOLLINGSWORTH
K012771 08/17/2001 TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX PAJUNK GMBH MARTIN HANGER
K012647 08/13/2001 TONOPORT V PAR MEDIZINTECHNIK GMBH LOTHAR ENGEL
K012889 08/28/2001 BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT PASCAL CO., INC. DAVID R JOY
K012509 08/06/2001 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM PHOENIX DIAGNOSTICS, INC. RAM NUNNA
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K012846 08/23/2001 ZIPPY, MODEL I88WA PILLAR TECHNOLOGY, INC. CHRIS TINSLEY
K012670 08/13/2001 BOSS 2000-3 VACUUM ERECTION DEVICE POS-T-VAC, INC. DENNIS L BELL
K012672 08/13/2001 BOSS-2000-2 VACUUM ERECTION DEVICE POS-T-VAC, INC. DENNIS L BELL
K012809 08/22/2001 SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 POWER MEDICAL INTERVENTIONS, INC. LAURENCE A POTTER
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K012794 08/21/2001 PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K012673 08/14/2001 PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K012761 08/17/2001 PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K012716 08/15/2001 MAINSTREAM WATER PURIFICATION DEVICE PRISMEDICAL CORP. ELAINE ALAMBRA
K012629 08/13/2001 ALWAYS DUETS PROCTER & GAMBLE CO. MARK M ANDERSON
K012444 08/01/2001 ABN ANEROID SPHYGMOMANOMETER PT. SUGIH INSTRUMENDO ABADI RICHARD GRAVER
K012498 08/03/2001 DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. ROBERT DUFFY
K012709 08/14/2001 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD ZECHUAN SHAO
K012653 08/13/2001 MALE LATEX CONDOM QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD ELI J CARTER
K012943 08/31/2001 THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE QUANTECH LTD. ROBIN J HELLEN
K012512 08/06/2001 SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM RADIANT MEDICAL ANDREW CLEELAND
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K012554 08/08/2001 REMSTAR AUTO CPAP SYSTEM RESPIRONICS, INC. DAVID J VANELLA
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K012767 08/17/2001 S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL S & C POLYMER GMBH CHRISTIAN BOTTCHER
K012552 08/08/2001 SCITON IMAGE HAIR REMOVAL LASER SCITON, INC. PETER N ALLEN
K012804 08/21/2001 PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS SCOTT E ALLEN CP SCOTT E ALLEN
K012663 08/13/2001 EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) SEDECAL USA, INC. DANIEL KAMM
K012546 08/07/2001 OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM SEDECAL USA, INC. DANIEL KAMM
K012935 08/31/2001 THECURVE, ITEM 507 SELECT MEDICAL SYSTEMS, INC. MONIQUE GIRARD
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K012799 08/21/2001 ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL SENORX, INC. AMY BOUCLY
K012863 08/24/2001 NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) SGMP CO., LTD. JANNA TUCKER
K012857 08/24/2001 NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O SGMP CO., LTD. JANNA P TUCKER
K012860 08/24/2001 POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) SGMP CO., LTD. JANNA P TUCKER
K012786 08/20/2001 POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) SHAMROCK MANUFACTURING COMPANY EMMY TJOENG
K012499 08/03/2001 ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K012772 08/17/2001 CTS-485 ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS ROBERT MORTON
K012711 08/14/2001 DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. HUAN CHUNG LI
K012710 08/14/2001 DISPOSABLE POWDERED VINYL EXAMINATION GLOVES SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. HUAN CHUNG-LI
K012770 08/17/2001 INFINITY MICRO2+ SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K012495 08/03/2001 OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K012461 08/01/2001 SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K012517 08/06/2001 CEREC3 VITABLOCKS SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K012853 08/24/2001 SMART GLOVE STERILE NITRILE EXAM GLOVE SMART GLOVE CORP. SDN BHD NG YEW SOON
K012856 08/24/2001 STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G SMART GLOVE CORP. SDN BHD FOO KHON PU
K012479 08/02/2001 STERILE NITRILE SURGICAL GLOVES (POWDERED) SMART GLOVE CORP. SDN BHD FOO KHON PU
K012938 08/31/2001 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS SMITH & NEPHEW, INC. TRUDE C NAFF
K012724 08/14/2001 SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 SMITH & NEPHEW, INC. JANICE HASELTON
K012778 08/20/2001 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS SMITH & NEPHEW, INC. DAVID HENLEY
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K012456 08/01/2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) SODEM SYSTEMS CAROLE BURNIER
K012453 08/01/2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) SODEM SYSTEMS CAROLE BURNIER
K012457 08/01/2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) SODEM SYSTEMS CAROLE BURNIER
K012859 08/24/2001 NU-SPEC D SOL WEISS MD INC SOL WEISS
K012505 08/03/2001 SOPRO595 INTRA ORAL CAMERA SOPRO PIERRE MONTILLOT
K012753 08/16/2001 SORING GMBH SONOCA 180/190 SORING GMBH MEDIZINTECHNIK CARL ALLETTO
K012528 08/06/2001 ICE SOUTHERN DENTAL INDUSTRIES, LTD. SAMANTHA J CHEETHAM
K012529 08/06/2001 ROK SOUTHERN DENTAL INDUSTRIES, LTD. SAMANTHA J CHEETHAM
K012881 08/28/2001 C3 ANTERIOR CERVICAL PLATE SYSTEM SPINE VISION, INC DAVID W MULLIS, JR
K012880 08/28/2001 STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) SSN GLOVES (M) SDN BHD CLINTON A TECK LEONG
K012896 08/28/2001 STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) SSN GLOVES (M) SDN BHD CLINTON A TECK LEONG
K012922 08/31/2001 ULTRAFLEX EV HEMOSTASIS INTRODUCER ST. JUDE MEDICAL KIRK S HONOUR
K012807 08/22/2001 MODIFICATION TO: COMPEL SURGICAL DRAPES STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K012523 08/06/2001 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. PATRICK FLEISCHHACKER
K012684 08/14/2001 REPROCESSED ELECTROSURGICAL ELECTRODE STERILMED, INC. PATRICK FLEISCHHACKER
K012685 08/14/2001 REPROCESSED ENDOSCOPIC ELECTRODES STERILMED, INC. PATRICK FLEISCHHACKER
K012578 08/09/2001 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC. PATRICK FLEISCHHACKER
K012574 08/09/2001 REPROCESSED FEMORAL COMPRESSION DEVICE STERILMED, INC. PATRICK FLEISCHHACKER
K012556 08/08/2001 REPROCESSED GUIDEWIRES STERILMED, INC. PATRICK FLEISCHHACKER
K012571 08/09/2001 REPROCESSED HARMONIC STERILMED, INC. PATRICK FLEISCHHACKER
K012537 08/07/2001 REPROCESSED IMAGING CATHETERS STERILMED, INC. PATRICK FLEISCHHACKER
K012598 08/10/2001 REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS STERILMED, INC. PATRICK F FLEISCHHACKER
K012682 08/14/2001 REPROCESSED LASER PROBE STERILMED, INC. PATRICK FLEISCHHACKER
K012579 08/09/2001 REPROCESSED PHACO TIPS STERILMED, INC. PATRICK FLEISCHHACKER
K012536 08/07/2001 REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES STERILMED, INC. PATRICK FLEISCHHACKER
K012677 08/14/2001 REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC. PATRICK FLEISCHHACKER
K012679 08/14/2001 REPROCESSED RF ARTHROSCOPY PROBES STERILMED, INC. PATRICK FLEISCHHACKER
K012678 08/14/2001 REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. PATICK FLEISCHHACKER
K012581 08/09/2001 REPROCESSED STONE RETRIEVAL BASKETS STERILMED, INC. PATRICK FLEISCHHACKER
K012597 08/10/2001 STERILMED REPROCESSED COMPRESSION SLEEVES STERILMED, INC. PATRICK FLEISCHHACKER
K012732 08/16/2001 INTEGRAPH FLASH, MODEL CI 110 STERITEC PRODUCTS, INC. LINDA NELSON
K012845 08/23/2001 SIMPLICITY SOFT QD MICRO INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K012757 08/17/2001 ITI DENTAL IMPLANT SYSTEM STRAUMANN USA LINDA JALBERT
K012739 08/16/2001 CONVERGE ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K012667 08/13/2001 REPROCESSED ARTHROSCOPIC SHAPERS SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. ROBERT S MCQUATE
K012658 08/13/2001 REPROCESSED COMPRESSION LIMB SLEEVES SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. ROBERT S MCQUATE
K012669 08/13/2001 REPROCESSED ELECTROSURGICAL ELECTRODES SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. ROBERT S MCQUATE
K012644 08/13/2001 REPROCESSED TROCARS AND CANNULAS SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. ROBERT S MCQUATE
K012865 08/27/2001 SUPERSTITCH VASCULAR SUTURING DEVICE SUTURA, INC. JAMES BONDS
K012717 08/15/2001 LIFE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012589 08/10/2001 FAST SET PUTTY SYNTHES (USA) THOMAS M MAGUIRE
K012812 08/22/2001 CAROTID GUIDING SHEATH TERUMO MEDICAL CORP. YUK-TING LEWIS
K012854 08/24/2001 RENAL GUIDING SHEATH TERUMO MEDICAL CORP. YUK-TING LEWIS
K012646 08/13/2001 TERUMO 30 GAUGE HYPODERMIC NEEDLE TERUMO MEDICAL CORP. BARBARA SMITH
K012462 08/01/2001 THEKEN LARGE CEMENT RESTRICTOR THEKEN SURGICAL,LLC RANDY THEKEN
K012525 08/06/2001 THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 THERMO DMA, INC. THOMAS DOLLAR
K012878 08/28/2001 THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 THERMO DMA, INC. THOMAS DOLLAR
K012518 08/06/2001 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 THERMO DMA, INC. THOMAS DOLLAR
K012882 08/28/2001 BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 THERMOELASTIC TECHNOLOGIES, INC. ART WARD
K012803 08/21/2001 AL-2000 COMBINED BIOMETER AND PACHYMETER TOMEY CORP. MAUREEN O'CONNELL
K012820 08/23/2001 AIA-PACK CTNI 2ND-GEN ASSAY TOSOH MEDICS, INC. LOIS NAKAYAMA
K012895 08/28/2001 HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KAPP
K012565 08/09/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K012921 08/31/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K012818 08/22/2001 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX TRIAGE MEDICAL INC GREG H HOLLAND
K012817 08/22/2001 HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED TRIAGE MEDICAL INC GREG HOLLAND
K012514 08/06/2001 DIGIPAN / DPI TROPHY RADIOLOGIE MARIE-PIERRE LABAT-CAMY
K012580 08/09/2001 ERCHONIA PL2000 TUCO INNOVATIONS, INC. KEVIN WALL
K012736 08/16/2001 MONOJECT SAFETY NEEDLE TYCO HEALTHCARE DAVID A OLSON
K012592 08/10/2001 EASYTRAVEL TZORA ACTIVE SYSTEMS LTD. YOEL ETZIONI
K012539 08/07/2001 VERASTEP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHESTER MCCOY
K012620 08/13/2001 SE-200 V.T.S.,INC. DENNIS L BELL
K012619 08/13/2001 VT-1 V.T.S.,INC. DENNIS L BELL
K012695 08/14/2001 VANGUARD REPROCESSED ARTHROSCOPIC WANDS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012687 08/14/2001 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012688 08/14/2001 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012700 08/14/2001 VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012480 08/02/2001 VANGUARD REPROCESSED INFLATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012698 08/14/2001 VANGUARD REPROCESSED PHACOEMULSIFICATION VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012544 08/07/2001 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM VASCULAR ARCHITECTS, INC. JEAN M CAILLOUETTE
K012842 08/23/2001 V*CARE MANUAL RESUSCITATOR VENTLAB CORP. MARGE WALLS-WALKER
K012587 08/10/2001 RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE VIDAMED, INC. YI CHEN
K012473 08/02/2001 VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT VIDENT BARBARA J LEWANDOWSKI
K012543 08/07/2001 VISION SCIENCES ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEU
K012636 08/13/2001 BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC. DARYL WISDAHL
K012662 08/13/2001 SE-100 VACUUM ERECTION DEVICE VTS, INC. DENNIS L BELL
K012639 08/13/2001 SE-300 VACUUM THERAPY SYSTEM VTS, INC. DENNIS L BELL
K012791 08/20/2001 C.T.M. MOBILITY SCOOTER MODEL # HS-320 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K012792 08/20/2001 C.T.M. MOBITIY SCOOTER MODEL #HS-360 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K012451 08/01/2001 PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 WELCH ALLYN PROTOCOL, INC. DONALD M ABBEY
K012455 08/01/2001 WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM WELCH ALLYN, INC. DAVID A YOUNG
K012800 08/21/2001 SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM WHITESIDE BIOMECHANICS, INC. DEBRA MEYER
K012839 08/23/2001 AUROPAL, ORDER-NO.: 2101 WIELAND EDELMETALLE GMBH & CO. GERHARD P0LZER
K012831 08/23/2001 BIO PORTADUR, ORDER-NO.:2017 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012826 08/23/2001 BIOPORTA G, MODEL 2052 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012841 08/23/2001 DUO PAL 6, ORDER-NO.: 2154 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012838 08/23/2001 ERO50, ORDER-NO.: 2070 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012840 08/23/2001 EURO 45, ORDER-NO.: 2064 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012827 08/23/2001 PORTA AURIUM, MODEL 2067 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012834 08/23/2001 PORTA GEO TI MODEL #2004 WIELAND EDELMETALLE GMBH & CO. GEHARD POLZER
K012835 08/23/2001 PORTA MAXIMUM, MODEL# 2066 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012828 08/23/2001 PORTA SMK 82, MODEL 2032 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012843 08/23/2001 PORTADUR P 2, MODEL #2031 WIELAND EDELMETALLE GMBH & CO. GEHARD POLZER
K012591 08/10/2001 ADVANCE UNICONDYLAR KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K012876 08/27/2001 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K012755 08/16/2001 AUTODIMER ASSAY MODEL # 1431 XTRANA, INC. PATRICK J O'LEARY


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