FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K010781 |
04/13/2001 |
3M ESPE HAUR |
3M COMPANY |
SCOTT ERICKSON |
K010789 |
04/27/2001 |
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
K010363 |
04/09/2001 |
ETEST MEROPENEM |
AB BIODISK |
ANNE BOLMSTROM |
K010670 |
04/26/2001 |
PICCOLO CHLORIDE TEST SYSTEM |
ABAXIS, INC. |
AMY LEVIN |
K010924 |
04/06/2001 |
MODIFICATION TO PLUM XL INFUSION PUMP |
ABBOTT LABORATORIES |
FRANK POKROP |
K010245 |
04/25/2001 |
ACTIVHEAL SCAR MANAGEMENT DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
CHRIS OAKES |
K003740 |
04/27/2001 |
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION |
AESCULAP, INC. |
DAVID W SCHLERF |
K003463 |
04/11/2001 |
SOCON SPINAL SYSTEM |
AESCULAP, INC. |
DAVID W SCHLERF |
K010275 |
04/27/2001 |
DRYSTAR 4500 PRINTER, MODEL 4500 |
AGFA MEDICAL IMAGING |
KIRSTEN PAULSON |
K010046 |
04/05/2001 |
NUVOLASE 532 MEDICAL LASER SYSTEM |
AMERICAN LASER CORP. |
DANIEL HOEFER |
K010931 |
04/09/2001 |
AMS SACRAL COLPOPEXY SLING, MODEL 72403501 |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
K010192 |
04/02/2001 |
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION |
ANTYLLOS MEDIZINTECHNIK GMBH |
HARALD JUNG |
K010063 |
04/02/2001 |
COUCH FOR TOTAL BODY RADIATION |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010172 |
04/18/2001 |
LEAD BLOCKS |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010174 |
04/18/2001 |
TRAY ADAPTERS, MULTIPLE |
ARPLAY MEDICAL S.A. |
RICHARD BORJ |
K010124 |
04/06/2001 |
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS |
ARTHREX, INC. |
VERNON BROWN |
K002627 |
04/26/2001 |
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER |
ATRIUM MEDICAL CORP. |
REBECCA DOLLOFF |
K010786 |
04/11/2001 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
K010462 |
04/11/2001 |
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) |
AVITA CORPORATION |
ALLEN REICH |
K003986 |
04/03/2001 |
ULTRASOUND SCANNER TYPE 2102 |
B-K MEDICAL A/S |
VILLY BRAENDER |
K010260 |
04/27/2001 |
HANSATOME MICROKERATOME |
BAUSCH & LOMB, INC. |
PAUL S KRAMSKY |
K003412 |
04/13/2001 |
ADVIA CENTAUR RUBELLA IGG ASSAY |
BAYER CORP. |
William J Pignato |
K010265 |
04/09/2001 |
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K010765 |
04/13/2001 |
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K010236 |
04/05/2001 |
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K010693 |
04/11/2001 |
VIGIL DNASE B CONTROL |
BECKMAN COULTER, INC. |
RICHARD T ROSS, RAC |
K010890 |
04/19/2001 |
BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) |
BECTON DICKINSON AND CO. |
PETER ZURLO |
K003542 |
04/06/2001 |
PREAMP CABLE, MODEL B400-1011PA |
BETA BIOMED SERVICES, INC. |
EJ Smith |
K010623 |
04/05/2001 |
RECONSTITUTION KIT & VIAL CONNECTOR |
BIOJECT, INC. |
NANCY GERTLAR |
K010550 |
04/24/2001 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 |
BIOMERIEUX, INC. |
Nancy Weaver |
K010664 |
04/05/2001 |
COPELAND RESURFACING HUMERAL HEADS |
BIOMET MANUFACTURING, INC. |
SARA A BAILEY |
K010774 |
04/13/2001 |
AVL HINGE KNEE SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K003494 |
04/09/2001 |
MIMIX BONE REPLACEMENT SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K003077 |
04/26/2001 |
SMARTSCREW MODEL 222006...227510 |
BIONX IMPLANTS, LTD. |
GERARD S CARLOZZI |
K010149 |
04/17/2001 |
WUJIN #3 FEMORAL NAIL |
BIOPRO, INC. |
ANGENA PAREKH |
K010196 |
04/05/2001 |
TOTAL CURE |
BISCO, INC. |
CYNDY ORIS |
K010955 |
04/26/2001 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM |
BOSTON MEDICAL TECHNOLOGIES, INC. |
CESIDIO TEMPESTA |
K010993 |
04/30/2001 |
ALIEN RX MICRO CANNULA, MODEL 4530 |
BOSTON SCIENTIFIC CORP. |
LIAS M QUAGLIA |
K010956 |
04/13/2001 |
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X |
BOSTON SCIENTIFIC CORP. |
ANDREA L RUTH |
K010853 |
04/18/2001 |
GUIDER SOFTIP GUIDING CATHETER XF 5F |
BOSTON SCIENTIFIC, TARGET |
ROXANE K BAXTER |
K010835 |
04/30/2001 |
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 |
BUSSE HOSPITAL DISPOSABLES, INC. |
VICKI ATOR |
K010778 |
04/13/2001 |
NIAGARA SLIM-CATH |
C.R. BARD, INC. |
PEGGY KEIFFER |
K010756 |
04/12/2001 |
CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K010758 |
04/12/2001 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K010104 |
04/11/2001 |
CANDELA LONG PULSE ND:YAG |
CANDELA CORP. |
JOAN CLIFFORD |
K010117 |
04/04/2001 |
GUIDANT AXIUS CORONARY SHUNT |
CARDIOTHORACIC SYSTEMS, INC. |
ANNE SCHLAGENHAFT |
K010133 |
04/05/2001 |
VERSALUX |
CENTRIX, INC. |
JOHN DISCKO |
K004046 |
04/26/2001 |
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
K010823 |
04/27/2001 |
SPAZZ |
COLOURS 'N MOTION |
VICTOR R BOX |
K001352 |
04/09/2001 |
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
K010776 |
04/06/2001 |
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS |
CORIN U.S.A. |
JOEL BATTS |
K010005 |
04/02/2001 |
CYNOSURE PHOTOGENICA DL |
CYNOSURE, INC. |
GEORGE CHO |
K010314 |
04/20/2001 |
DIMENSION CTNI CALIBRATOR |
DADE BEHRING, INC. |
GEORGE PLUMMER |
K010313 |
04/20/2001 |
DIMENSION CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
GEORGE PLUMMER |
K010912 |
04/05/2001 |
ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
K010742 |
04/12/2001 |
MOSS MIAMI 5.5MM TITANIUM PIN NUT |
DEPUY ACROMED |
FRANK MAAS |
K010810 |
04/18/2001 |
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
K010171 |
04/06/2001 |
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
K010878 |
04/18/2001 |
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K010350 |
04/09/2001 |
STA -CALIBRATOR HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B. LE |
K010324 |
04/09/2001 |
STA-QUALITY HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B. LE |
K011003 |
04/20/2001 |
SAFESTING AND SAFESTING HUB |
DIASOL, INC. |
MONICA ABELES |
K010792 |
04/03/2001 |
MAMMOGRAPH |
DIGITEC MEDICAL SERVICE CORP. |
JAMES J MCGINTY |
K003272 |
04/04/2001 |
FLO-BOOT |
DISCOVERY GROUP LLC. |
RICHARD J FREER |
K002929 |
04/17/2001 |
DORNIER COMPACT ALPHA LITHOTRIPTER |
DORNIER MEDTECH AMERICA, INC. |
CAROL WERNECKE |
K010488 |
04/09/2001 |
ATAC PAK AST REAGENT KIT |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
K003126 |
04/11/2001 |
BIPOLAR TRIGGER-FLEX PROBE |
ELLMAN INTL., INC. |
FRANK LIN |
K002973 |
04/26/2001 |
EMBOL-X INTRODUCER, MODEL CF00200 |
EMBOL-X, INC. |
ED LEE |
K010112 |
04/02/2001 |
BIPOLAR COAGULATION SYSTEM |
ENABLE MEDICAL CORP. |
MARK L FRIEDMAN |
K002981 |
04/09/2001 |
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 |
ETHICON ENDO-SURGERY, INC. |
RUTH A WOOD |
K010722 |
04/27/2001 |
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH |
ETHICON, INC. |
GREGORY R JONES |
K011081 |
04/24/2001 |
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS |
EXACTECH, INC. |
GARY J MILLER |
K010086 |
04/09/2001 |
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010092 |
04/02/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010268 |
04/27/2001 |
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K002892 |
04/05/2001 |
FRSENIUS PD IQCARD CYCLER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFEILD |
K003326 |
04/11/2001 |
FUNET AMY MAMA BODY THERMOMETER |
FUNAI RADIO & COMMUNICATIONS CORP. |
JOHN LIN |
K003613 |
04/03/2001 |
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K002997 |
04/11/2001 |
FIESTA IMAGING OPTION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K010164 |
04/09/2001 |
ICG MODULE |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
K010829 |
04/05/2001 |
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES |
GENERAL GLOVES CORP. |
JOHN CHEN |
K010830 |
04/09/2001 |
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES |
GENERAL GLOVES CORP. |
JOHN CHEN |
K010779 |
04/10/2001 |
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT |
GIBBONS SURGICAL CORP. |
LISA CRISSON |
K003830 |
04/09/2001 |
ENT ENDOSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K003812 |
04/30/2001 |
VACUETTE SPEEDY QUICK-RELEASE HOLDER |
GREINER VACUETTE NORTH AMERICA, INC. |
Judi Smith |
K010684 |
04/12/2001 |
RX HERCULINK PLUS BILIARY STENT SYSTEM |
GUIDANT CORP. |
BYRON LAMBERT |
K010822 |
04/18/2001 |
AB CARDIETTE START 200 HV |
H&C MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
K011086 |
04/26/2001 |
HARDYDISK BACITRACIN, 10MCG, MODEL Z927 |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
K010767 |
04/10/2001 |
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES |
HORIZON MEDICAL PRODUCTS, INC. |
PENNY M NORTHCUTT |
K003023 |
04/30/2001 |
COBE HC 700 MIDI HEMOCONCENTRATOR |
HOSPAL INDUSTRIE |
BARBARA A WATSON |
K010100 |
04/06/2001 |
AVON PATELLO-FEMORAL JOINT PROSTHESIS |
HOWMEDICA OSTEONICS CORP. |
ELIZABETH A STAUB |
K010757 |
04/11/2001 |
LFIT V40 FEMORAL HEAD COMPONENTS |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K010845 |
04/18/2001 |
MODIFICATION TO OSTEONICS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K010115 |
04/16/2001 |
REFLEX ANTERIOR CERVICAL PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K010801 |
04/06/2001 |
T2 FEMORAL NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K010170 |
04/18/2001 |
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
K010889 |
04/25/2001 |
BABY DOPPLEX 3000 MK 2 (BD3000) |
HUNTLEIGH HEALTHCARE, INC. |
B.J. COLLEYPRIEST |
K010894 |
04/25/2001 |
BABY DOPPLEX 3002 (BD3002) |
HUNTLEIGH HEALTHCARE, INC. |
B.J. COLLEYPRIEST |
K010178 |
04/27/2001 |
SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AU-KAU |
K010558 |
04/03/2001 |
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K010379 |
04/13/2001 |
IL TEST FREE PROTEIN S |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K010220 |
04/09/2001 |
XTRACTOR, MODEL M143 |
INSTRUMENTS MEDICAUX G.B., INC. |
MARTIN PAQUETTE |
K010708 |
04/30/2001 |
APPLICATOR TIP/DUAL SPRAYER KIT |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
K010531 |
04/18/2001 |
ILT DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K003561 |
04/17/2001 |
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 |
INVACARE CORP. |
RAE ANN FARROW |
K010840 |
04/20/2001 |
SYNPLUG |
ISOTIS NV |
CYNTHIA J M. NOLTE |
K010328 |
04/09/2001 |
MULTIPLE (IZON DNA BLOOD COLLECTION KIT) |
IZON BUSINESS PRODUCTS, INC. |
JACK WERTZ |
K010114 |
04/11/2001 |
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) |
JOHNSON & JOHNSON VISION CARE, INC. |
SHARON BRIGGS |
K010569 |
04/09/2001 |
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
K003994 |
04/13/2001 |
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K003325 |
04/27/2001 |
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
K010994 |
04/23/2001 |
TAKE ONE BITE MODIFIED |
KERR CORP. |
COLLEEN BOSWELL |
K010199 |
04/05/2001 |
PJUR EROS WATER FORMULATION |
L.C.C. PJUR GROUP GERMANY |
RICHARD HARRIS |
K010860 |
04/03/2001 |
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
K010861 |
04/03/2001 |
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
K010113 |
04/12/2001 |
LASER MECHANISMS LASER SCANNING SYSTEM |
LASER MECHANISMS, INC. |
JEFFREY HOCKING |
K010859 |
04/05/2001 |
THE LIBERATOR WHEELCHAIR |
LIBERATOR WHEELCHAIRS, INC. |
RICARDO KAUFMANN |
K011016 |
04/27/2001 |
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT |
LSI SOLUTIONS |
CHRISTINE E EHMANN |
K010252 |
04/26/2001 |
MAGNUM |
MAGNUM EQUIPMENT L.L.C. |
MONTE REGAL |
K010296 |
04/11/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 |
MARINA MEDICAL INSTRUMENTS, INC. |
JIHAD (JAY) MANSOUR |
K003521 |
04/19/2001 |
DISPO-MED 7.6 LITER SHARPS CONTAINER |
MASTER BENEFITS, INC. |
JOHNNY TABOADA |
K010225 |
04/24/2001 |
DOSIMETRY CHECK |
MATH RESOLUTIONS, LLC. |
WENDEL D RENNER |
K010353 |
04/27/2001 |
MED-LOGICS DISPOSABLE ALK TUBING |
MED-LOGICS, INC. |
GARY MOCNIK |
K010821 |
04/11/2001 |
ECHOSEED/IODINE-125 SEEDS, MODEL 6733 |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
SUBHASH PATEL |
K010074 |
04/03/2001 |
MODEL 455GE PHASED ARRAY WRIST COIL |
MEDICAL ADVANCES, INC. |
MICHAEL LEIGH |
K000442 |
04/24/2001 |
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX |
MEDICAL CONCEPTS DEVELOPMENT, INC. |
DAVID PADGET |
K011053 |
04/20/2001 |
OPTIMA |
MEDICAL INDUSTRIES AMERICA, INC. |
LEE SMITH |
K010259 |
04/26/2001 |
MEDIFACE PACS |
MEDIFACE CO., LTD. |
CARL PERSON |
K010900 |
04/05/2001 |
STS-T LITHOTRIPTER, MODEL STS-T |
MEDSTONE INTL., INC. |
RONALD BERGESON |
K010959 |
04/13/2001 |
VERDICT -II BAR; VERDICT -II BZO |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K010561 |
04/05/2001 |
VERDICT -II BAR/BZO |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K010564 |
04/05/2001 |
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K010737 |
04/04/2001 |
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
MARIE HOLM |
K010341 |
04/20/2001 |
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
K010529 |
04/27/2001 |
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
K010720 |
04/11/2001 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K010906 |
04/05/2001 |
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 |
MEDTRONIC VASCULAR |
KAREN CLEMENT |
K010709 |
04/23/2001 |
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS |
MENTOR CORP. |
DONNA CRAWFORD |
K010377 |
04/05/2001 |
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 |
MINIMED, INC. |
JENNIFER LYONS |
K010570 |
04/09/2001 |
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K010309 |
04/18/2001 |
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR |
MUTOH AMERICA CO., LTD. |
DANIEL] KAMM |
K000592 |
04/12/2001 |
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
K002617 |
04/05/2001 |
PERIFORM PERINEOMETRIC PROBE, MODEL 8300 |
NEEN DESIGN LTD. |
MARK READ |
K002889 |
04/06/2001 |
PNS MAGNETIC STIMULATOR SYSTEM |
NEOTONUS, INC. |
SHEILA HEMEON-HEYER |
K010264 |
04/27/2001 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
RICHARD D BLISS, JR |
K010451 |
04/25/2001 |
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN, R.A.C. |
K010417 |
04/26/2001 |
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 |
NUCLEAR ASSOC., DIV. INOVISION LP |
CHRISTINE G CASTLEBERRY |
K010784 |
04/10/2001 |
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 |
NUCLETRON CORP. |
ROBERT APPLEBAUM |
K010880 |
04/20/2001 |
NUMED HIGH PRESSURE PTA CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
K010795 |
04/11/2001 |
CAPNOPROBE SL, MODEL 2000 |
OPTICAL SENSORS, INC. |
Gary Syring |
K003145 |
04/20/2001 |
ORIGEN BLADDER HOLDER |
ORIGEN BIOMEDICAL, INC. |
RICHARD MARTIN |
K010273 |
04/25/2001 |
CRANIAL MOLDING ORTHOSIS |
ORTHOTIC SOLUTIONS, INC. |
JOSEPH F TERPENNING |
K002036 |
04/17/2001 |
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD |
OSI MEDICAL, INC. |
JAMES R LEVANI |
K002726 |
04/06/2001 |
TCOYF FERTILITY SOFTWARE VERSION 1.0 |
OVUSOFT, LLC. |
GENE GRANT |
K992607 |
04/27/2001 |
SONICAID SYSTEM 8002 |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
E.J. Smith |
K010537 |
04/24/2001 |
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
AMANDA SHEPPARD |
K010536 |
04/24/2001 |
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
AMANDA SHEPPARD |
K003350 |
04/05/2001 |
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
K010967 |
04/17/2001 |
LIVESURE COCAINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K011011 |
04/13/2001 |
LIVESURE MORPHINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K010508 |
04/23/2001 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K011116 |
04/24/2001 |
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST |
PASCO LABORATORIES, INC. |
LINDA DILLON |
K010740 |
04/17/2001 |
FG-36UX, FIBER ULTRASOUND GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
K010365 |
04/30/2001 |
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE |
PERSONAL PRODUCTS CO. |
MARYLOU PANICO |
K010719 |
04/10/2001 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR |
PERUSAHAAN GETAH ASAS SDN BHD |
KONG C TAN |
K010653 |
04/05/2001 |
AT HOME DRUG TEST, MODEL 9068 T |
PHAMATECH |
CARL A MONGIOVI |
K010654 |
04/05/2001 |
AT HOME DRUG TEST, MODEL 9078 T |
PHAMATECH |
CARL A MONGIOVI |
K010655 |
04/05/2001 |
AT HOME DRUG TESTT, MODEL 9150 T |
PHAMATECH |
CARL A MONGIOVI |
K010836 |
04/11/2001 |
AT WORK DRUG TEST, MODEL 9147T AWT |
PHAMATECH |
CARL A MONGIOVI |
K010833 |
04/11/2001 |
AT WORK DRUG TEST, MODEL 9177T AWT |
PHAMATECH |
CARL A MONGIOVI |
K010762 |
04/02/2001 |
PHILIPS BV LIBRA |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
K003274 |
04/06/2001 |
LPC-PLUS ACETABULAR CUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K010195 |
04/17/2001 |
PREMIER ULTRASONIC SCALER AND INSERTS |
PREMIER DENTAL PRODUCTS CO. |
WILLIAN FREZEL |
K003842 |
04/13/2001 |
PRESCOTT'S SURGICAL SPEAR |
PRESCOTT'S, INC. |
PAUL REDNER |
K010630 |
04/17/2001 |
Y-TZP POWDER AND PROCERA ALLZIRKON |
PROCERA SANDVIK, INC. |
MARTIN STERNER |
K003206 |
04/25/2001 |
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 |
PROXIMA THERAPEUTICS, INC. |
DEBORAH J MOORE |
K010704 |
04/18/2001 |
DORNIR LC-1 CPAP SYSTEM |
PRYM MEDICAL LTD. |
SHOSHANA FRIEDMAN |
K010486 |
04/10/2001 |
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
K010461 |
04/03/2001 |
ADVIA RETIC PLUS |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
K010926 |
04/12/2001 |
R-SI-LINE METAL-BITE |
R-DENTAL DENTALERZEUGNISSE GMBH |
ANDREAS SPRAFKE |
K003809 |
04/20/2001 |
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS |
RAPID DIAGNOSTICS, INC. |
CHARLES C.F. YU |
K003417 |
04/04/2001 |
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K002000 |
04/10/2001 |
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K003676 |
04/09/2001 |
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR |
RITA MEDICAL SYSTEMS |
ERIN MAZZONE |
K010255 |
04/20/2001 |
CAVITY VARNISH |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K004010 |
04/26/2001 |
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
K010593 |
04/05/2001 |
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT |
SA SCIENTIFIC, INC. |
ARBI A SHADFAN |
K004038 |
04/30/2001 |
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
K010625 |
04/24/2001 |
EUROSPITAL EU-TTG IGA UMANA |
SCIMEDX CORP. |
Gary Lehnus |
K010726 |
04/26/2001 |
MODIFICATION TO MIRAGE |
SEGAMI CORP., INC. |
PHILIPPE A BRIANDET |
K000889 |
04/27/2001 |
SENOJ IMPLANT SYSTEM |
SENOJ BIOCARE, INC. |
PENNY WOLLUM |
K003701 |
04/05/2001 |
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) |
SENTECH MEDICAL SYSTEMS, INC. |
LYDIA BIGGIE |
K010110 |
04/03/2001 |
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K010626 |
04/23/2001 |
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K010627 |
04/24/2001 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K010628 |
04/23/2001 |
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K010914 |
04/20/2001 |
BEAUTIFIL |
SHOFU DENTAL CORP. |
CINDKY RHOADES |
K003559 |
04/26/2001 |
TCI (TINNITUS CONTROL INSTRUMENT) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVID S SLAVIN |
K003558 |
04/24/2001 |
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVID S SLAVIN |
K010942 |
04/12/2001 |
U04 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
AMY SHAW HOSLER |
K010489 |
04/10/2001 |
DYONICS VISION 111 MOBILE VIDEO UNIT |
SMITH & NEPHEW, INC. |
STEVEN JACKSON |
K010509 |
04/27/2001 |
CEDARS-SINAI BPGS AND MOCO |
SMV AMERICA |
PAULA MCLEAN |
K002856 |
04/02/2001 |
AT3C70 TRANSDUCER |
SONORA MEDICAL SYSTEMS |
COLLEEN HITTLE |
K994083 |
04/04/2001 |
STANNAH POWER CHAIR, MODEL 201 |
STANNAH POWER CHAIRS LTD. |
CHARLES EDGELL |
K010647 |
04/13/2001 |
SIMPLICITY INFUSER INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K010846 |
04/12/2001 |
SIMPLICITY SILVER SET SOFT INFUSION |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K010788 |
04/20/2001 |
SIMPLICITY SOFT QD EASY INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
K010886 |
04/30/2001 |
SIMPLICITY WING INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLASS |
K010676 |
04/18/2001 |
SIMPLICITY WINGED QD INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K010969 |
04/20/2001 |
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
K010839 |
04/18/2001 |
CLS VARUS STEM/CLS 135 STEM |
SULZER ORTHOPEDICS, INC. |
BRUCE WALDON |
K010371 |
04/27/2001 |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT |
SURETEX, LTD. |
LON D MCILVAIN |
K010637 |
04/20/2001 |
SONOTOME ULTRASONIC ASPIRATOR TIPS |
SYNERGETICS, INC. |
ALAN T BECKMAN |
K003527 |
04/09/2001 |
MODIFICATION TO SYNTHES (USA) POLYPIN |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K010527 |
04/25/2001 |
SYNTHES (USA) IMF SCREWS |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K003275 |
04/23/2001 |
SYNTHES SYNMESH SPACER SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
K010814 |
04/13/2001 |
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K010984 |
04/20/2001 |
EMIT 2000 GENTAMICIN PLUS ASSAY |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K010812 |
04/13/2001 |
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K010934 |
04/20/2001 |
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K010960 |
04/26/2001 |
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K010962 |
04/26/2001 |
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K001915 |
04/27/2001 |
GRAFT MARKER RING |
T. KOROS SURGICAL INSTRUMENTS CORP. |
TIBOR KOROS |
K010578 |
04/25/2001 |
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 |
TAGA MEDICAL TECHNOLOGIES, INC. |
GARY AUSTIN |
K003987 |
04/26/2001 |
URS-1K (KETONE TESST) |
TECO DIAGNOSTICS |
DINDO CARRILLO |
K010412 |
04/02/2001 |
FLEXIBLE ENDOSCOPIC SCISSORS |
TELEMED SYSTEMS, INC. |
MICHAEL CARROLL |
K010383 |
04/18/2001 |
TEMP SCAN |
TENGHI CO. LTD |
TONY C S. CHANG |
K010883 |
04/06/2001 |
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE |
TERATECH CORP. |
CHARLES F HOTTINGER |
K010441 |
04/26/2001 |
FREELITE KAPPA FREE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K010440 |
04/26/2001 |
FREELITE LAMBDA FREE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K002902 |
04/09/2001 |
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS |
THE KENDALL COMPANY |
FRANK J FUCILE |
K010283 |
04/26/2001 |
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 |
THERAGENICS CORP. |
JANET E ZEMAN |
K010271 |
04/03/2001 |
THINKINGNET |
THINKING SYSTEMS CORP. |
J B WANG |
K003731 |
04/10/2001 |
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE |
THOMAS MEDICAL PRODUCTS, INC. |
PETER J RAPP |
K010662 |
04/27/2001 |
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL |
TISSUELINK MEDICAL, INC. |
ROBERTA THOMPSON |
K010671 |
04/09/2001 |
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE |
TONG RUHN MEDICAL PRODUCTS CO., LTD. |
ANTONIO L GIACCIO |
K010129 |
04/05/2001 |
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K010665 |
04/27/2001 |
TRANSAMERICA DIGITAL EMS |
TRANSAMERICA MEDICAL SYSTEMS |
JOHN F DUNN |
K010782 |
04/27/2001 |
TRANSAMERICAN TENS |
TRANSAMERICA MEDICAL SYSTEMS |
JOHN F DUNN |
K010909 |
04/09/2001 |
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
TYCO HEALTHCARE GROUP, LP |
ROBERT ZOTT |
K003381 |
04/23/2001 |
SHIELDING NEEDLE HOLDER |
U.S. SAFETY SYRINGES CO., INC. |
DAVID A HOINES |
K010035 |
04/04/2001 |
IVS TUNNELLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K010213 |
04/20/2001 |
MODIFICATION TO CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
K010010 |
04/02/2001 |
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR |
VALLEYLAB, INC. |
JULIE ROSS |
K010507 |
04/12/2001 |
VISTAKON (METHAFILCON A) CONTACT LENSES |
VISTAKON |
MICHAEL J TERSAK |
K010288 |
04/13/2001 |
ANEUVYSION MULITICOLOR DNA PROBE KIT |
VYSIS |
RUSSEL K ENNS |
K002131 |
04/13/2001 |
LACTOSORB ETHMOID STENT |
WALTER LORENZ SURGICAL, INC. |
TREVOR BYRD |
K001997 |
04/02/2001 |
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) |
WHITE KNIGHT HEALTHCARE, INC. |
ART WARD |
K001892 |
04/03/2001 |
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) |
WHITE KNIGHT HEALTHCARE, INC. |
ART WARD |
K001893 |
04/02/2001 |
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) |
WHITE KNIGHT HEALTHCARE, INC. |
ART WARD |
K010421 |
04/13/2001 |
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K003440 |
04/20/2001 |
SOFTLASE - SURGICAL DIODE LASER SYSTEM |
ZAP LASERS, INC. |
DAVID W SCHLERF |
K010685 |
04/02/2001 |
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) |
ZIMMER, INC. |
STEPHEN H MCKELVEY |