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 |
JONATHAN 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 |
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 |
K012730 |
09/13/2001 |
CLEARFIL PORCELAIN BOND ACTIVATOR |
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 |
K003620 |
09/19/2001 |
NSI HEXED AND NON-HEXED IMPLANT SYSTEM |
NSI |
GRETA M HOLS |
K012165 |
09/19/2001 |
OLDELFT THORASCAN MODEL NUMBER 180T |
NUCLETRON CORP. |
LISA DIMMICK |
K000035 |
09/28/2001 |
OMNICARE DENTAL IMPLANT SYSTEM |
OMNICARE DENTAL IMPLANT CENTER |
FLOYD G LARSON |
K012125 |
09/17/2001 |
OPUS MAGNUM ANCHOR & INSERTER |
OPUS MEDICAL, INC. |
MARK RITCHART |
K011403 |
09/11/2001 |
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE |
ORTHOGEN CORP. |
ELAINE DUNCAN |
K011087 |
09/19/2001 |
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE |
ORTHOVITA, INC. |
ANGIE IDE |
K011774 |
09/05/2001 |
R120 MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
K011338 |
09/13/2001 |
OTO-CEM |
OTOTECH, INC. |
MICHAEL G FARROW |
K010232 |
09/21/2001 |
PRE-POWDERED NITRILE EXAMINATION GLOVES |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
K011980 |
09/12/2001 |
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 |
PACE MEDICAL |
ROBERT C MACE |
K012392 |
09/04/2001 |
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 |
PACE MEDICAL |
ROBERT C MACE |
K003548 |
09/04/2001 |
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS |
PADPRO LLC. |
DANIEL KAMM |
K010618 |
09/10/2001 |
PALOMAR DERMALUX PULSED LIGHT SYSTEM |
PALOMAR |
Marcy Moore |
K012360 |
09/06/2001 |
LC TEMPORARY FILLING |
PARKELL, INC. |
NELSON J GENDUSA |
K012150 |
09/20/2001 |
PATTON ENDO-BAG |
PATTON MEDICAL CORP. |
MICHAEL T PATTON |
K011223 |
09/20/2001 |
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM |
PAXMED INTERNATIONAL |
FLOYD G LARSON |
K010467 |
09/28/2001 |
UNIVERSAL DENTAL COPING (UDC) |
PAXMED INTERNATIONAL |
FLOYD G LARSON |
K011836 |
09/07/2001 |
MPF ACETABULAR CUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K011945 |
09/12/2001 |
RIGID GAS PERMEABLE CONTACT LENS SOLUTION |
POLYMER TECHNOLOGY CORP. |
DEBRA L.B. KETCHUM |
K012515 |
09/19/2001 |
BIFURCATED VACCINATING NEEDLE |
PRECISION MEDICAL PRODUCTS, INC. |
RONALD D WOLFE |
K012160 |
09/27/2001 |
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 |
PREMIER DENTAL PRODUCTS CO. |
BARRY HALE |
K000031 |
09/10/2001 |
AQUANET, MODEL EC 2000 |
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
OTHMAR VOGEL |
K011996 |
09/19/2001 |
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K012653 |
09/21/2001 |
MALE LATEX CONDOM |
QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD |
ELI J CARTER |
K002241 |
09/20/2001 |
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM |
QUANTUM BIOENGINEERING, LTD. |
FLOYD G LARSON |
K991250 |
09/20/2001 |
QUANTUM VERSATILITY IMPLANT SYSTEM |
QUANTUM BIOENGINEERING, LTD. |
RAUL R MENA |
K011059 |
09/17/2001 |
INFARED EAR THERMOMETER, MODEL TH8 SERIES |
RADIANT INNOVATION, INC. |
SUSAN D GOLDSTEIN-FALK |
K012978 |
09/18/2001 |
RANDOX GENTAMICIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K011568 |
09/28/2001 |
RANDOX LIPOPROTEIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K012318 |
09/12/2001 |
RANDOX THERAPEUTIC DRUG CALIBRATOR |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K011017 |
09/24/2001 |
PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT |
REHABILICARE, INC. |
EDWARD F VALDEZ |
K012042 |
09/20/2001 |
KINETIC CANNULA |
RELIANCE MEDICAL CORP. |
ROBERT W NICKS |
K012007 |
09/19/2001 |
RHS HELMET |
RESTORATIVE HEALTH SVS, INC. |
DAVID J BLOCH |
K011911 |
09/17/2001 |
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K012371 |
09/19/2001 |
TINA-QUANT TRANSFERRIN VER.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K012393 |
09/19/2001 |
TINA-QUANT TRANSFERRIN VER.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K012397 |
09/26/2001 |
URISYS 2400 URINE TEST STRIP |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K011763 |
09/05/2001 |
OMNIDOS |
SCANDITRONIX MEDICAL AB |
ALF OHMAN |
K012033 |
09/20/2001 |
MULTIFUNCTION ENDOSCOPIC INSTRUMENT |
SEEDLING ENTERPRISES. LLC. |
DEBBIE IAMPIETRO |
K011407 |
09/11/2001 |
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO |
SEMPERMED USA, INC. |
KATIE LEVINSON |
K012023 |
09/12/2001 |
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE |
SENORX, INC. |
AMY BOUCLY |
K012004 |
09/25/2001 |
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE |
SENORX, INC. |
AMY BOUCLY |
K012799 |
09/04/2001 |
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL |
SENORX, INC. |
AMY BOUCLY |
K012863 |
09/21/2001 |
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SGMP CO., LTD. |
JANNA TUCKER |
K012857 |
09/21/2001 |
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 |
09/21/2001 |
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) |
SGMP CO., LTD. |
JANNA P TUCKER |
K011961 |
09/26/2001 |
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K011045 |
09/11/2001 |
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
SHEN WEI (USA), INC. |
BELLE CHOU |
K011044 |
09/10/2001 |
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K011613 |
09/17/2001 |
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
JANNA P TUCKER |
K012711 |
09/18/2001 |
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. |
HUAN CHUNG LI |
K012202 |
09/27/2001 |
NUMARIS 4VA15A |
SIEMENS MEDICAL CORP. |
JAMIE YIEH |
K011066 |
09/11/2001 |
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) |
SMART GLOVE CORP. SDN BHD |
NG-YEW SOON |
K012479 |
09/26/2001 |
STERILE NITRILE SURGICAL GLOVES (POWDERED) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K011944 |
09/19/2001 |
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 |
SMITH & NEPHEW, INC. |
STEVEN JACKSON |
K012456 |
09/21/2001 |
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) |
SODEM SYSTEMS |
CAROLE BURNIER |
K012922 |
09/25/2001 |
ULTRAFLEX EV HEMOSTASIS INTRODUCER |
ST. JUDE MEDICAL |
KIRK S HONOUR |
K012845 |
09/14/2001 |
SIMPLICITY SOFT QD MICRO INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
K012270 |
09/28/2001 |
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM |
Stryker Endoscopy |
ALISA MILLER |
K012055 |
09/06/2001 |
3.25MM SPLINE TWIST IMPLANT |
SULZER DENTAL, INC. |
FOSTER BOOP |
K011806 |
09/07/2001 |
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
K011954 |
09/19/2001 |
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE |
SULZER ORTHOPEDICS, INC. |
BRUCE WALDON |
K012173 |
09/28/2001 |
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM |
SULZER SPINE-TECH |
KRISTYN M BENSON |
K012865 |
09/25/2001 |
SUPERSTITCH VASCULAR SUTURING DEVICE |
SUTURA, INC. |
JAMES BONDS |
K012405 |
09/04/2001 |
EXTRUDE MODIFIED |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
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 |
K011815 |
09/06/2001 |
SYNTHES LCP PROXIMAL HUMERUS PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
K012114 |
09/28/2001 |
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM |
SYNTHES (USA) |
MATTHEW M HULL |
K012372 |
09/28/2001 |
SYSMEX UF-50 |
SYSMEX CORP. |
CHRIS STUKEL |
K990323 |
09/28/2001 |
TE ME NA POLYSTIM NERVE STIMILATOR |
TE ME NA S.A.R.L. |
JOE HARMS |
K010732 |
09/27/2001 |
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) |
TELEMEDIC SYSTEMS, INC. |
STENEN CHERNOFF |
K012086 |
09/13/2001 |
AQUARIUSNET SERVER |
TERARECON, INC. |
DAVID W SCHLERF |
K012074 |
09/25/2001 |
XBO1-824-18/19/20 BIOPSY FORCEPS |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
K011854 |
09/04/2001 |
TOKUYAMA M-BOND |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K011434 |
09/18/2001 |
G7 AUTOMATED HPLC ANALYZER |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
K012565 |
09/12/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K012067 |
09/17/2001 |
CLINCARE LATEX SURGEON'S GLOVE |
TTK HEALTHCARE LTD. |
ELI J CARTER |
K012539 |
09/06/2001 |
VERASTEP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K011574 |
09/28/2001 |
UNIPLANT DENTAL IMPLANT SYSTEM |
UNIVERSAL IMPLANT SYSTEMS, INC. |
FLOYD G LARSON |
K011800 |
09/27/2001 |
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
K012842 |
09/18/2001 |
V*CARE MANUAL RESUSCITATOR |
VENTLAB CORP. |
MARGE WALLS-WALKER |
K010913 |
09/28/2001 |
VYGON SPLIT CANNULA INTRODUCER |
VYGON CORP. |
ROBERT SCHIFF |
K012098 |
09/20/2001 |
PRECLUDE PERICARDIAL MEMBRANE |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
K012260 |
09/19/2001 |
WIENER LAB. UREA UV CINETICA AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K012329 |
09/21/2001 |
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |