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 |
K012657 |
08/13/2001 |
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP |
HYGIA HEALTH SERVICES, INC. |
GEOFF M FATZINGER |
K012650 |
08/13/2001 |
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP |
HYGIA HEALTH SERVICES, INC. |
GEOFF M FATZINGER |
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 |
K012665 |
08/13/2001 |
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
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 |
K012909 |
08/30/2001 |
XTERRA GT POWER WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
K012877 |
08/27/2001 |
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER |
IVOCLAR USA, INC. |
ANDERJEET GULATI |
K012496 |
08/03/2001 |
CARBON POST |
J. MORITA USA, INC. |
KEITH A BARRITT |
K012849 |
08/03/2001 |
GLASS POST |
J. MORITA USA, INC. |
KEITH A BARRITT |
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 |
K012617 |
08/13/2001 |
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... |
JOSTRA AG |
KATHLEEN JOHNSON |
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 |
K012714 |
08/14/2001 |
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR |
KOON SENG SDN.BHD |
LIM WENG HENG |
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 |
K012735 |
08/14/2001 |
CLEARFIL DC CEMENT |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
K012734 |
08/14/2001 |
CLEARFIL NEW BOND |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
K012705 |
08/14/2001 |
CLEARFIL PHOTO CORE |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
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 |
K012624 |
08/13/2001 |
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
K012632 |
08/13/2001 |
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
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 |
K012458 |
08/01/2001 |
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
K012459 |
08/01/2001 |
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE |
MEDTRONIC VASCULAR |
TINA BENOIT |
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 |
K012744 |
08/16/2001 |
INTRAORAL LENS OPTION TO SPECTROSHADE |
MHT OPTIC RESEARCH AG |
MARKUS ANGST |
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 |
K012801 |
08/21/2001 |
N2000 BASE STATION, N2001 NURSE STATION |
NEPTEC DESIGN GROUP, LTD. |
CHARLES H KYPER |
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 |
K012510 |
08/06/2001 |
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM |
NXSTAGE MEDICAL, INC. |
KAREN ST.ONGE |
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 |
K012475 |
08/02/2001 |
CAAS II QVA |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
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 |
K012515 |
08/06/2001 |
BIFURCATED VACCINATING NEEDLE |
PRECISION MEDICAL PRODUCTS, INC. |
RONALD D WOLFE |
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 |
K012850 |
08/24/2001 |
RECORDING AND STIMULATING ELECTRODE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
K012554 |
08/08/2001 |
REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
K012633 |
08/13/2001 |
RESPIRONICS HEATED HUMIDIFIER |
RESPIRONICS, INC. |
DAVID J VANELLA |
K012848 |
08/23/2001 |
WINNER CM4 COMBINATION UNIT |
RICH-MAR CORP. |
DAVID RICHARDS |
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 |
K012819 |
08/23/2001 |
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 |
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
JAY MANSOUR |
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 |
K012787 |
08/20/2001 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K012788 |
08/20/2001 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
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 |