| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K012013 |
06/28/2001 |
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T |
A & D ENGINEERING, INC. |
JERRY WANG |
| K011929 |
06/20/2001 |
HANDPIECE SHEATH-MODEL #A910 |
AARON MEDICAL, INC. |
RICHARD KOZLOFF |
| K011801 |
06/08/2001 |
FUTURA TOPCAP NON GAMMA-2 |
AB ARDENT |
CLYDE E INGERSOLL |
| K012014 |
06/12/2001 |
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
EVE A CONNER |
| K011752 |
06/06/2001 |
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY |
ACCUFAST, INC. |
DON LOGAN |
| K012018 |
06/28/2001 |
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 |
ACMI CORPORATION |
FRANK J FUCILE |
| K011730 |
06/05/2001 |
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K011994 |
06/26/2001 |
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K011962 |
06/22/2001 |
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K012010 |
06/27/2001 |
MODIFICATION TO LR 5200 FILM RECORDER |
AGFA CORP. |
T.WHIT ATHEY |
| K011824 |
06/11/2001 |
AGILENT M2636B TELEMON B MONITOR (TELEMON B) |
AGILENT TECHNOLOGIES, INC. |
DENISE HALEY |
| K012037 |
06/29/2001 |
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 |
AIRSEP CORP. |
CHARLOTTE H HAMILTON |
| K011721 |
06/04/2001 |
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K011814 |
06/11/2001 |
AMEDITECH IMMUTEST DRUG SCREEN COC |
AMEDITECH, INC. |
JOHN WU |
| K011813 |
06/11/2001 |
AMEDITECH IMMUTEST DRUG SCREEN THC |
AMEDITECH, INC. |
JOHN WU |
| K012159 |
06/22/2001 |
RAPID DRUG SCREEN |
AMERICAN BIO MEDICA CORP. |
FRAN WHITE |
| K011706 |
06/04/2001 |
FLEXICAST PRIME |
AMERICAN DENT-ALL, INC. |
VACHAKAN H KHOIE |
| K011705 |
06/04/2001 |
SUPREMCAST |
AMERICAN DENT-ALL, INC. |
VACHAKAN H KHOIE |
| K011910 |
06/19/2001 |
IN-FAST BONE SCREW SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
| K012029 |
06/28/2001 |
REMEDY MODEL 2Z12 |
APOLLO CORP. |
ADRIAN SWEEN |
| K011761 |
06/06/2001 |
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K011808 |
06/11/2001 |
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) |
ASIA-MED GMBH AND CO KG |
KEVIN WALLS |
| K011834 |
06/12/2001 |
BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
| K011722 |
06/04/2001 |
ATRICURE BIPOLAR COAGULATION SYSTEM |
ATRICURE, INC. |
MARK L FRIEDMAN |
| K011819 |
06/11/2001 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K011779 |
06/07/2001 |
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM |
AVID CARE CORP. |
JONATHAN S KAHAN |
| K011912 |
06/19/2001 |
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K011975 |
06/25/2001 |
HORIZON OUTLOOK WITH DOSECOM |
B. BRAUN MEDICAL, INC. |
LINDA MORGAN |
| K011718 |
06/04/2001 |
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K011796 |
06/08/2001 |
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K011963 |
06/22/2001 |
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY |
BAYER CORP. |
KENNETH T EDDS |
| K011982 |
06/26/2001 |
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE |
BD |
GREGORY W MORGAN |
| K011967 |
06/25/2001 |
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE |
BD |
GREGORY W MORGAN |
| K011858 |
06/14/2001 |
INTERLINK THREADED LOCK CANNULA |
BD |
GREGORY W MORGAN |
| K011984 |
06/26/2001 |
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET |
BECTON DICKINSON & CO. |
M. WENDY BOSSHARDT |
| K011853 |
06/13/2001 |
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 |
BIO-RAD |
DONNA CHAPMAN |
| K011867 |
06/14/2001 |
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 |
BIO-RAD |
DONNA CHAPMAN |
| K012019 |
06/28/2001 |
COLOR BUFFED (CB) DDH FEMORAL STEM |
BIOMET, INC. |
DALENE T BINKLEY |
| K011795 |
06/08/2001 |
WORLAND UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
TRACY J BICKEL |
| K012000 |
06/27/2001 |
1.5MM BONE FIXATION KIT |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K012001 |
06/27/2001 |
SMARTSCREW |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K011970 |
06/25/2001 |
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM |
BIOSAFE LABORATORIES, INC. |
JACK A MAGGIORE |
| K012032 |
06/29/2001 |
FIRST SPEP |
BISCO, INC. |
KATHY LONG |
| K011906 |
06/19/2001 |
BACK-UP MEIER GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K011965 |
06/25/2001 |
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 |
BOSTON SCIENTIFIC CORP. |
ROBERT J MICHALIK |
| K011889 |
06/18/2001 |
ULTRA -THIN SDS BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K011909 |
06/19/2001 |
ULTRA-THIN SDS BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K012035 |
06/29/2001 |
BRAUN PRECISION SENSOR PRO, MODEL BP 2590 |
BRAUN GMBH |
FRED SCHLADOR |
| K011728 |
06/04/2001 |
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K011797 |
06/08/2001 |
BIOZTECT SENSOR AND BIOZTECT CABLE |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRAIN PARK |
| K011988 |
06/26/2001 |
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C |
CARDIOFOCUS, INC. |
JOSEPH CURTIS |
| K011861 |
06/14/2001 |
BERNOULLI VENTILATOR MANAGEMENT SYSTEM |
CARDIOPULMONARY CORP. |
JOHN LAVIOLA |
| K011877 |
06/15/2001 |
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM |
CARL ZEISS JENA GMBH |
JOHNATHAN S KAHAN |
| K011855 |
06/13/2001 |
WAMPOLE HS-CRP ELISA |
CARTER-WALLACE, INC. |
MAUREEN GARNER |
| K011840 |
06/12/2001 |
CERVILENZ UTERINE MEASURING SOUND |
CERVILENZ INC |
JUDY F GORDON |
| K011888 |
06/18/2001 |
PRESSURE ACTIVATED CHECK VALVE |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PALUCH |
| K011848 |
06/13/2001 |
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE |
CIRCON VIDEO |
JERRY CROUTHERS |
| K011876 |
06/15/2001 |
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 |
CIRCON VIDEO |
JOHN DELUCIA |
| K011849 |
06/13/2001 |
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS |
CIRCON VIDEO |
WAYNE B STERNER |
| K011835 |
06/12/2001 |
COBE REVOLUTION |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K011880 |
06/15/2001 |
COMPEX SPORT |
COMPEX S.A. |
ANSIS M HELMANIS |
| K011893 |
06/18/2001 |
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES |
CONTACT COLOR SRL |
MARIA E DONAWA |
| K011812 |
06/11/2001 |
SPECTRUM VENTRICULAR CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K011828 |
06/12/2001 |
CYNOSURE ACCLAIM DERMATOLOGY LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K011852 |
06/12/2001 |
DIMENSION HAIC ASSAY, MODEL DF105 |
DADE BEHRING, INC. |
CATHY CRAFT |
| K012005 |
06/27/2001 |
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
| K011999 |
06/27/2001 |
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
| K011868 |
06/14/2001 |
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS |
DEBIOTECH S.A. |
SEAN CURRY |
| K011958 |
06/22/2001 |
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT |
DENKA SEIKEN'S |
SEIYA SATO |
| K011762 |
06/07/2001 |
HI-WAVE; POUR-PLUS |
DENPLUS, INC. |
SHUOJIA DONG |
| K011862 |
06/14/2001 |
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT |
DENVER BIOMEDICAL, INC. |
BONNIE B VIVIAN |
| K011831 |
06/12/2001 |
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
DENVER BIOMEDICAL, INC. |
BONNIE VIVIAN |
| K011810 |
06/11/2001 |
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING |
DEPUY, INC. |
JANET G JOHNSON |
| K011729 |
06/04/2001 |
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 |
DNI NEVADA, INC. |
KRISTINE BOGGS |
| K011736 |
06/05/2001 |
DRG QUICKMIX |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIES |
| K012003 |
06/27/2001 |
DRG REACTION CHAMBER/SAFETY TIP |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K011773 |
06/07/2001 |
DORNIER LITHOTRIPTER 140("DOLI 140") |
DORNIER |
SUZANNE COURTNEY |
| K011873 |
06/15/2001 |
DORNIER LITHOTRIPTER S("DOLI S") & DORNIER LITHOTRIPTER S-XP ("DOLI S-XP") |
DORNIER |
SUZANNEW COURTNEY |
| K011839 |
06/12/2001 |
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C |
DOXA CERTEX AB |
JONATHAN S KAHAN |
| K011898 |
06/18/2001 |
E-STETH ELECTRONIC STETHOSCOPE |
E-MED INNOVATIONS, INC. |
HUGH E HACKNEY |
| K011697 |
06/01/2001 |
EBI XFIX ACCESS PELVIC FIXATOR |
EBI, L.P. |
FREDERIC TESTA |
| K012024 |
06/28/2001 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K011711 |
06/04/2001 |
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K011856 |
06/13/2001 |
RADIOGRAPHIC MARKERS |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K011830 |
06/12/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K012031 |
06/28/2001 |
MODIFICATION TO THERMAL ANGEL |
ESTILL MEDICAL TECHNOLOGIES, INC. |
DANIEL T KISTNER |
| K011976 |
06/25/2001 |
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) |
EXACTECH, INC. |
GARY J MILLER |
| K011794 |
06/08/2001 |
XLTEK LED GOGGLES, MODEL LED-01 |
EXCEL TECH. LTD. |
SONJA MARKEZ |
| K011757 |
06/06/2001 |
EXEL COMFORTPOINT INSULIN PEN NEEDLE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K011754 |
06/06/2001 |
EXEL SECURETOUCH PTP SYRINGE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K011874 |
06/15/2001 |
FADASIS MEDICAL FM-1 NO BLENDER |
FADASIS MEDICAL, INC. |
RAYMOND RIDDLE |
| K011983 |
06/26/2001 |
INSIGHT GENESIS |
FASSTECH |
LEE BRODY |
| K011964 |
06/25/2001 |
INSIGHT MILLENNIUM PLUS |
FASSTECH |
LEE BRODY |
| K011992 |
06/26/2001 |
FHC MICROTARGETING DRIVE SYSTEM |
FHC, INC. |
FREDERICK HAER |
| K011775 |
06/07/2001 |
MICRO TARGETING DRIVE SYSTEM |
FHC, INC. |
FREDERICK HAER |
| K011939 |
06/21/2001 |
FOTONA DUALIS, FOTONA DUALIS PLUS |
FOTONA D.D. |
MOJCA VALJAVEC |
| K011950 |
06/21/2001 |
SEEDNET, MODEL FP6T5, FP5T5, FP5T3 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K011917 |
06/20/2001 |
ADVANCED HIP ASSESSMENT SOFTWARE |
GE LUNAR CORP. |
JAMES P RASKOB |
| K011843 |
06/12/2001 |
GENZYME DIRECT-AMYLASE TEST REAGENT |
GENZYME CORP. |
BARBARA PIZZA |
| DEN010002 |
06/11/2001 |
GIVEN DIAGNOSTIC IMAGING SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K011699 |
06/01/2001 |
VACUETTE EVACUATED BLOOD COLLECTION TUBES |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
JUDI SMITH |
| K012043 |
06/29/2001 |
VACUETTE EDTA K2 GEL TUBES |
GREINER VACUETTE NORTH AMERICA, INC. |
JUDI SMITH |
| K011786 |
06/08/2001 |
VACUETTE SAFETY BLOOD COLLECTION SET |
GREINER VACUETTE NORTH AMERICA, INC. |
JUDI SMITH |
| K011881 |
06/18/2001 |
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
| K012002 |
06/27/2001 |
VIKING OPTIMA GUIDING CATHETER |
GUIDANT CORP. |
STACEY SIMON |
| K012012 |
06/28/2001 |
ECG HOME |
H&C MEDICAL DEVICES SPA |
ATTILIO CASTELLI |
| K011741 |
06/05/2001 |
CRIT-LINE MONITOR III TQA (CLM TQA) |
HEMAMETRICS |
MATTHEW L HAYNIE |
| K012045 |
06/29/2001 |
HIGHGATE CURVED ROD SYSTEM |
HIGHGATE ORTHOPAEDICS |
KAREN E WARDEN |
| K011979 |
06/25/2001 |
ALLERSHARP ALLERGY SKIN TESTER |
HMB MEDICAL CONCEPTS, LTD. |
GAVIN MCLACHLAN |
| K011916 |
06/20/2001 |
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES |
HORIZON MEDICAL PRODUCTS, INC. |
PENNY M NORTHCUTT |
| K012027 |
06/28/2001 |
MODIFICATION TO XIA SPINE SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K011948 |
06/21/2001 |
HOFFMAN II HYBRID RING CLAMP |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K012026 |
06/28/2001 |
TRIDENT ALL POLY CUP |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K012008 |
06/27/2001 |
STS RANGE , MODELS STS20,STS30,STS40 |
HUNTLEIGH HEALTHCARE, INC. |
AUDREY WITKO |
| K011866 |
06/14/2001 |
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES |
HYPERBARIC TECHNOLOGIES, INC. |
DAVE HEANEY |
| K011971 |
06/25/2001 |
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K012047 |
06/29/2001 |
3I CALCIUM SULFATE BONE CEMENT |
IMPLANT INNOVATIONS, INC. |
MARY L VERSTYNEN |
| K011904 |
06/19/2001 |
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) |
IMPLEX CORP. |
ROBERT A POGGIE |
| K011914 |
06/19/2001 |
HYDRO2, HS-75 |
INNOVISION, INC. |
DON M WOODFORD |
| K011698 |
06/01/2001 |
STRAUMANN GBR SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| K011972 |
06/25/2001 |
DIRECT BILIRUBIN REAGENT |
INTERSECT SYSTEMS, INC. |
MARK E LEGAZ |
| K011986 |
06/26/2001 |
SAFE-STEER GUIDE WIRE SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA L MISAJON |
| K011938 |
06/21/2001 |
OIL FOR EMBRYO CULTURE |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K011900 |
06/18/2001 |
GLUCOSE (HEXOKINASE) |
JAS DIAGNOSTICS, INC. |
DAVID JOHNSTON |
| K012038 |
06/29/2001 |
JAS URIC ACID LIQUID REAGENT |
JAS DIAGNOSTICS, INC. |
DAVID JOHNSTON |
| K011748 |
06/06/2001 |
FIRST FILL R.C.S. |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K011780 |
06/07/2001 |
K-ASSAY C1-INA |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K011841 |
06/12/2001 |
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| K011700 |
06/01/2001 |
MODULITH SLK LITHOTRIPTER |
KARL STORZ ENDOSCOPY |
JENNIFER S PORTUGAL |
| K011793 |
06/08/2001 |
KSEA FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K011943 |
06/21/2001 |
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR |
KENSEY NASH CORP. |
JULIE N BRODERICK |
| K011908 |
06/19/2001 |
OPTIBOND SOLO PLUS 3 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K011725 |
06/04/2001 |
OLYMPUS SUCTION PUMP, MODEL KV-5 |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
ROGER GRAY |
| K011860 |
06/14/2001 |
KEYST0NE MEDICAL PICC CATHETER |
KEYSTONE MEDICAL |
ALAN P SCHWARTZ |
| K011713 |
06/04/2001 |
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K011859 |
06/14/2001 |
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS |
KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH |
|
| K011968 |
06/25/2001 |
STREERABLE PTCA GUIDEWIRE |
LAKE REGION MFG., INC. |
JEFF PUMPER |
| K011960 |
06/22/2001 |
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "POCKETPRO OR POCKETPRO S4") |
LARES RESEARCH, INC. |
THOMAS H LOUISELL |
| K011792 |
06/08/2001 |
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
LATEXX PARTNERS BHD. |
CHRISTINA SMITH |
| K011791 |
06/08/2001 |
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR |
LATEXX PARTNERS BHD. |
CHRISTINA SMITH |
| K011987 |
06/26/2001 |
MODIFIED M-IV MAMMOGRAPHY SYSTEM |
LORAD, A HOLOGIC CO. |
ROAIDA RIZKALLAH |
| K011703 |
06/01/2001 |
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES |
LUMENIS |
LISA MCGRATH |
| K011715 |
06/04/2001 |
MACROPORE IB RESORBABLE PLUG |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K012025 |
06/28/2001 |
MACROPORE SURGIWRAP (TS) |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K011746 |
06/06/2001 |
MB 11 |
MAICO DIAGNOSTIC GMBH |
DANIEL E EGGAN |
| K011785 |
06/08/2001 |
NOVEL PRINT CYAN ALGINATES |
MANUFACTURERA DENTAL CONTINENTAL |
GARY S MOCNIK |
| K012009 |
06/27/2001 |
MX8000 IDT CT SYSTEM |
MARCONI MEDICAL SYSTEMS, INC. |
ROBERT L TUROCY |
| K011851 |
06/13/2001 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K011845 |
06/12/2001 |
MILLCOMP |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K011905 |
06/19/2001 |
SNIPER ELITE MODEL-OR-E3872XX SERIES |
MAXXIM MEDICAL |
GAIL DOHERTY |
| K011740 |
06/05/2001 |
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) |
MEDDEV CORP. |
SUZANNA BRICK |
| K011731 |
06/05/2001 |
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
| K012006 |
06/27/2001 |
MEDICAL DEPOT POWER NEB 1 |
MEDICAL DEPOT, INC. |
ART WARD |
| K011790 |
06/08/2001 |
MICROCRUISER PLUS INTRODUCER SET |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K012030 |
06/28/2001 |
PORTABLE INTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K011991 |
06/26/2001 |
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR |
MEDRAD, INC. |
LORRAINE R FREDES |
| K011817 |
06/11/2001 |
BRIDGE FX |
MEDTRONIC AVE, INC. |
JOHN RIOLO |
| K011998 |
06/27/2001 |
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K011864 |
06/14/2001 |
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B |
MEDTRONIC VASCULAR |
MARIE HOLM |
| K011784 |
06/08/2001 |
MODIFICATION TO ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
| K011811 |
06/11/2001 |
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
DAN REIGLE |
| K011844 |
06/12/2001 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS., INC. |
LEE LEICHTER |
| K011751 |
06/06/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011753 |
06/06/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011707 |
06/04/2001 |
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 |
MERITS MEDICAL INDUSTRIES CO., LTD. |
WINSTON ANDERSON |
| K011955 |
06/22/2001 |
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
| K011981 |
06/25/2001 |
MHS 5000 |
MICRO HEALTH SYSTEMS INC. |
ROBERT BARNES |
| K011937 |
06/21/2001 |
TRULINE INFUSION CATHETERS |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K011952 |
06/21/2001 |
DRUGS OF ABUSE MULTI-TEST STRIP |
MICRODIAGNOSTICS, INC. |
JUNE SHOZI |
| K011826 |
06/11/2001 |
EPS320 CARDIAC STIMULATOR |
MICROPACE PTY. LTD. |
MICHAEL CEJNAR |
| K011726 |
06/04/2001 |
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER |
MILLENIUM BIOLOGIX, INC. |
ROBERT SCHIFF |
| K011833 |
06/12/2001 |
MB 103 MILLENNIUM BLADES |
MILLENNIUM BIOMEDICAL, INC. |
JERRY KAENI |
| K012028 |
06/28/2001 |
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 |
MISONIX, INC. |
ALBERT F CLANCY |
| K011734 |
06/05/2001 |
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
| K011816 |
06/11/2001 |
MINI MULTILEAF COLLIMATOR, MODEL KMI |
MRC SYSTEMS GMBH |
JORG STEIN |
| K011926 |
06/20/2001 |
ELEC-MATE E |
NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K011820 |
06/11/2001 |
DENTORIUM CONVERTIBLE ACRYLIC |
NATS CORP. |
RICHARD C LANZILLOTTO |
| K011946 |
06/21/2001 |
THE SPIN SNAP-OFF SCREW |
NEW DEAL, S.A. |
NORMAN F ESTRIN |
| K011821 |
06/11/2001 |
MODIFICATION TO THE I.C.O.S SCREW |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K011875 |
06/15/2001 |
MODIFICATION TO THE TAC' PIN |
NEWDEAL S.A. |
MORGANE GRENIER |
| K011716 |
06/04/2001 |
THE UNI-CLIP STAPLE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K011823 |
06/11/2001 |
BIOREHAB SYSTEM |
NICOLET BIOMEDICAL, INC. |
GARY J SYRING |
| K011818 |
06/11/2001 |
STERILE EMG ELECTRODES |
NICOLET BIOMEDICAL, INC. |
GARY SYRING |
| K011918 |
06/20/2001 |
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K011949 |
06/21/2001 |
ELK LASER IMAGER, MODEL EL-DRY 4000 |
NISHIMOTO SANGYO CO., LTD. |
GARY J ALLSEBROOK |
| K012020 |
06/28/2001 |
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC |
NON-INVASIVE MONITORING SYSTEMS, INC. |
ALLAN F BRACK |
| K011704 |
06/01/2001 |
NPAC EAR THERMOMETER MODEL TD 402 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K011928 |
06/20/2001 |
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K011720 |
06/04/2001 |
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K011886 |
06/15/2001 |
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K011769 |
06/07/2001 |
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND |
OPUSDENT LTD. |
SHOSHANA FRIEDMAN |
| K011887 |
06/18/2001 |
AVALON CUP SYSTEM |
ORTHOPEDIC SOURCE INC. |
STEVEN L MANDELL |
| K011827 |
06/12/2001 |
ORTELIUS 800 |
ORTHOSCAN LTD. |
SHOSHANA FRIEDMAN |
| K011807 |
06/11/2001 |
SCS CLARIS SPINAL SCREWS, TYPES V,G,E |
ORTHOTEC,LLC |
KAREN E WARDEN |
| K011879 |
06/15/2001 |
3A DENTAL IMPLANT SYSTEM |
OSSECO BIOSOURCE, LTD |
MICHELE H VOVOLKA |
| K011774 |
06/07/2001 |
R120 MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K011951 |
06/21/2001 |
EZ SYRINGE |
OWEN MUMFORD, LTD. |
ROBERT SHAW |
| K011710 |
06/04/2001 |
OXOID PBP2 1 LATEX AGGLUTINATION TEST |
OXOID, LTD. |
A. HOLLINGSWORTH |
| K011980 |
06/25/2001 |
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 |
PACE MEDICAL |
ROBERT C MACE |
| K011997 |
06/27/2001 |
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX |
PAJUNK GMBH |
MARTIN HAUGER |
| K011747 |
06/05/2001 |
PALOMAR LC 100 DIODE LASER |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
MARCY MOORE |
| K011891 |
06/18/2001 |
PANAG |
PANAG INTERNATIONAL |
PETER KALABAKAS |
| K011899 |
06/18/2001 |
PF 5050 PRESSURE UNIT, MODEL PF 5050 |
PERIMED AB |
BJORN BAKKEN |
| K011783 |
06/07/2001 |
MULTI-SNARE SET |
PFM PRODUKTE FUR DIE MEDIZIN AG |
SALVADORE F PALOMARES |
| K011723 |
06/04/2001 |
ANTI-SNORING DEVICE OR "ASD" |
PI MEDICAL |
LINDA S ALEXANDER |
| K011836 |
06/12/2001 |
MPF ACETABULAR CUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K011719 |
06/04/2001 |
PLUS CANCELLOUS BONE SCREWS |
PLUS ORTHOPEDICS |
HARTMUT LOCH, RAC |
| K011945 |
06/21/2001 |
RIGID GAS PERMEABLE CONTACT LENS SOLUTION |
POLYMER TECHNOLOGY CORP. |
DEBRA L.B. KETCHUM |
| K013068 |
06/28/2001 |
BIOSCANNER 2000 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K011993 |
06/26/2001 |
QUANTUM BLAST |
PRIDE MOBILITY PRODUCTS CORP. |
GENE R KULON |
| K011789 |
06/08/2001 |
PROCEDURE MASKS: PM4-301 AND PM4-304 |
PRIMELINE MEDICAL PRODUCTS, INC. |
KATHERINE CO |
| K011996 |
06/27/2001 |
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
| K011933 |
06/20/2001 |
GLYCOSAL II HBA 1C TEST |
PROVALIS DIAGNOSTICS LTD. |
THOMAS M TSAKERIS |
| K011712 |
06/04/2001 |
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K011895 |
06/18/2001 |
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH |
PWA INDUSTRIES SDN. BHD. |
K. KARUNAKARAN |
| K011995 |
06/26/2001 |
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
QUALITY LATEX PRODUCTS MALAYSIA SDN BHD |
SHARENE WAN |
| K011759 |
06/06/2001 |
RADIUS NEXT GENERATION GUIDEWIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
MAUREEN FINLAYSON |
| K011771 |
06/06/2001 |
RANDOX THEOPHYLLINE |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K012224 |
06/16/2001 |
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW |
RANFAC CORP. |
GEORGE J HATTUB |
| K012044 |
06/29/2001 |
BI-PHASIC INFILTRATOR |
RELIANCE MEDICAL CORP. |
ROBERT W NICKS |
| K012042 |
06/29/2001 |
KINETIC CANNULA |
RELIANCE MEDICAL CORP. |
ROBERT W NICKS |
| K011714 |
06/04/2001 |
BIPAP PRO BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K012040 |
06/29/2001 |
RAMP MYOGLOBIN ASSAY |
RESPONSE BIOMEDICAL CORP. |
WILLIAM J RADVAK |
| K012007 |
06/27/2001 |
RHS HELMET |
RESTORATIVE HEALTH SVS, INC. |
DAVID J BLOCH |
| K011837 |
06/12/2001 |
LIFECARD CF 7 DAY |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
| K011911 |
06/19/2001 |
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K011822 |
06/11/2001 |
PIT AND FISSURE CHEMICAL CURING SEALANT |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
| K011846 |
06/12/2001 |
BIOTECH POWERED WHEELCHAIR, C650PW |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
JEN KE-MIN |
| K011738 |
06/05/2001 |
ACCU-CHEK ACTIVE SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K011935 |
06/21/2001 |
REJUVENIQUE MODEL #RJV10 |
SALTON, INC. |
GEORGIA C RAVITZ |
| K011763 |
06/07/2001 |
OMNIDOS |
SCANDITRONIX MEDICAL AB |
ALF OHMAN |
| K012033 |
06/29/2001 |
MULTIFUNCTION ENDOSCOPIC INSTRUMENT |
SEEDLING ENTERPRISES. LLC. |
DEBBIE IAMPIETRO |
| K011924 |
06/20/2001 |
POWDERED BLUE NITRILE EXAMINATION GLOVES |
SELTOM PACIFIC SDN. BHD. |
S SEGARAN |
| K011922 |
06/20/2001 |
POWDERED LATEX EXAMINATION GLOVES |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K012023 |
06/28/2001 |
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE |
SENORX, INC. |
AMY BOUCLY |
| K012004 |
06/27/2001 |
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE |
SENORX, INC. |
AMY BOUCLY |
| K011974 |
06/25/2001 |
SENSAID |
SENSIDYNE, INC. |
GEORGE MASON |
| K012034 |
06/29/2001 |
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT |
SENSORMEDICS CORP. |
ALEX STENZLER |
| K011961 |
06/22/2001 |
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K011883 |
06/18/2001 |
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K011884 |
06/18/2001 |
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K011882 |
06/18/2001 |
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K011885 |
06/18/2001 |
SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K012016 |
06/28/2001 |
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K011825 |
06/11/2001 |
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE |
SIGHTLINE TECHNOLOGIES LTD. |
SIMCHA EDELL |
| K011907 |
06/18/2001 |
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM |
SIMS LEVEL 1, INC. |
GABRIEL J MURACA, JR. |
| K011925 |
06/20/2001 |
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO |
SIMS PORTEX, INC. |
BRAIN D FARIAS |
| K011842 |
06/12/2001 |
SABRE COMPAC |
SLE LIMITED |
FRANK FERGUSON |
| K011944 |
06/21/2001 |
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 |
SMITH & NEPHEW, INC. |
STEVEN JACKSON |
| K011985 |
06/26/2001 |
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT |
SMITH & NEPHEW, INC. |
TIM CRABTREE |
| K011766 |
06/07/2001 |
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 |
ST. JUDE MEDICAL |
ANGELA BYLAND |
| K011788 |
06/08/2001 |
EVERSTICK |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K011799 |
06/08/2001 |
EVERSTICKNET |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K011838 |
06/12/2001 |
CENTRIFUGAL PUMP |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
| K012011 |
06/28/2001 |
MODIFICATION TO A620 EEG |
STOELTING CO. |
KENNETH L BIRD |
| K011755 |
06/06/2001 |
STRYKER T4 HYTREL (R) TOGAS |
STRYKER CORP. |
SUZANNE VELASQUEZ |
| K011806 |
06/11/2001 |
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K011954 |
06/22/2001 |
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE |
SULZER ORTHOPEDICS, INC. |
BRUCE WALDON |
| K011913 |
06/19/2001 |
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES |
SUN-RAIN SYSTEM CORP. |
YANG TIEN-HISING |
| K011765 |
06/07/2001 |
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
SUSAN D GOLDSTEIN-FALK |
| K011717 |
06/04/2001 |
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
SUSAN D GOLDSTEIN-FALK |
| K011781 |
06/07/2001 |
INTERCEPT-URETHRAL MICROCOIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K011901 |
06/18/2001 |
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 |
SURVIVALINK CORP. |
JOHN CARLINE |
| K011798 |
06/08/2001 |
CORERESTORE 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K011897 |
06/18/2001 |
NORIAN SRS BONE VOID FILLER |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K011857 |
06/14/2001 |
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
| K011969 |
06/25/2001 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K011815 |
06/11/2001 |
SYNTHES LCP PROXIMAL HUMERUS PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
| K011978 |
06/25/2001 |
SYNTHES LCP PROXIMAL TIBIA PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
| K011878 |
06/15/2001 |
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
SYVA CO. |
SUSAN L COLLINS |
| K011947 |
06/21/2001 |
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
SYVA CO. |
SUSAN L COLLINS |
| K011920 |
06/20/2001 |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN L COLLINS |
| K011701 |
06/01/2001 |
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
JEN KE-MIN |
| K012041 |
06/29/2001 |
THE HAMMER MODEL H100 |
TENACORE HOLDINGS, INC. |
BRAND CASO |
| K011804 |
06/11/2001 |
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K011941 |
06/21/2001 |
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 |
THE KENDALL COMPANY |
MICHAEL SPEARS |
| K011869 |
06/14/2001 |
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K011768 |
06/07/2001 |
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 |
THERMO-ELECTRIC CO. |
LAWRENCE E MADSON |
| K011727 |
06/04/2001 |
TRANSSEPTAL NEEDLE/TROCAR |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K011854 |
06/13/2001 |
TOKUYAMA M-BOND |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K011942 |
06/21/2001 |
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS |
TORNIER |
IRENE GOSSET |
| K011745 |
06/06/2001 |
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
| K011744 |
06/05/2001 |
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
| K011803 |
06/11/2001 |
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K011709 |
06/04/2001 |
UNI-GOLD STREP A TEST KIT |
TRINITY BIOTECH, PLC |
FIONA CAMPBELL |
| K011800 |
06/08/2001 |
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K011832 |
06/12/2001 |
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012017 |
06/28/2001 |
VARISEED 7.0 |
VARIAN MEDICAL SYSTEMS |
LINDA S NASH |
| K011863 |
06/14/2001 |
VCS-A SERIES CLAMP |
VASCULAR CONTROL SYSTEMS, INC |
AL MEMMOLO |
| K011957 |
06/22/2001 |
IVENT 201 PORTABLE VENTILATOR |
VERSAMED LTD. |
KEN RAICHMAN |
| K011702 |
06/01/2001 |
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX |
VERTIS NEUROSCIENCE, INC. |
LORI GLASTETTER |
| K011787 |
06/08/2001 |
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE |
VIDAMED, INC. |
YI CHEN |
| K011903 |
06/18/2001 |
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE |
VIVOMETRICS, INC. |
KEITH GILROY |
| K011756 |
06/06/2001 |
ADMIRA FLOW |
VOCO GMBH |
EVAN DICK |
| K011708 |
06/04/2001 |
MODIFICATION TO WARTNER WART REMOVAL SYSTEM |
WARTNER MEDICAL PRODUCTS |
NANCY LUM-WILSON |
| K011953 |
06/21/2001 |
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K012048 |
06/29/2001 |
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K011865 |
06/14/2001 |
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
ZOLL MEDICAL CORP. |
PAUL DIAS |
| K011847 |
06/13/2001 |
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE |
ZYNERGY CARDIO VASULAR (ZCV), INC. |
JING ZHANG |
