| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K031350 |
06/23/2003 |
3TP SOFTWARE OPTION |
3TP LLC |
VINCENT J MCGILL |
| K031353 |
06/19/2003 |
SOLUTION FACE MASKS |
A PLUS INTERNATIONAL, INC |
SOLOMON CHEN |
| K031048 |
06/16/2003 |
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K031052 |
06/13/2003 |
CARESTART HCG ONE-STEP PREGNANCY TEST |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K030935 |
06/23/2003 |
BERKELEY V-10 VACUUM CURETTAGE SYSTEM |
ACMI CORPORATION |
FRANK FUCILE |
| K030684 |
06/03/2003 |
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH |
ACMI CORPORATION |
FRANK FUCILE |
| K023726 |
06/17/2003 |
TENS PRO 900 |
ACUMED MEDICAL SUPPLIES, LTD. |
RICHARD KEEN |
| K031705 |
06/17/2003 |
SKYLIGHT IMAGING SYSTEM |
ADAC LABORATORIES |
COLEEN A COLEMAN |
| K031872 |
06/20/2003 |
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] |
ADAC LABORATORIES |
CHARLENE BRUMBAUGH |
| K024298 |
06/30/2003 |
ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
JOHN GREEN |
| K031303 |
06/04/2003 |
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) |
AESCULAP, INC. |
MATTHEW M HULL |
| K031198 |
06/20/2003 |
SCANX 10 |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K024019 |
06/03/2003 |
ARTERIALFLOW SYSTEM, MODEL 32A |
AIRCAST, INC. |
STEPHEN L KENNEY |
| K024344 |
06/03/2003 |
PNEUTON VENTILATOR |
AIRON CORPORATION |
G. ERIC GJERDE |
| K024360 |
06/10/2003 |
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K031271 |
06/17/2003 |
ONE-STEP PREGNANCY TEST |
AMERISOURCE PHARMACAL, INC. |
FRAN WHITE |
| K031233 |
06/18/2003 |
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K031626 |
06/19/2003 |
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K024000 |
06/26/2003 |
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER |
ANGIOMETRX INC. |
CARL YOUNGMANN |
| K022394 |
06/05/2003 |
EZMANAGER PLUS |
ANIMAS CORP. |
MICHAEL J ANDREWS |
| K023815 |
06/19/2003 |
C-1805M |
ANODIA SYSTEMS |
THAD J OVERMYER |
| K023896 |
06/19/2003 |
C-1890 |
ANODIA SYSTEMS |
THAD OVERMYER |
| K031029 |
06/19/2003 |
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K031141 |
06/30/2003 |
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE |
ASAP ENDOSCOPIC PRODUCTS GMBH |
MARTINA GUNDEROTH |
| K024111 |
06/10/2003 |
ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K031177 |
06/19/2003 |
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K031041 |
06/19/2003 |
FLUENCY TRACHEOBRONCHIAL STENT GRAFT |
BARD PERIPHERAL VASCULAR |
AYMEE R BERRY |
| K030099 |
06/17/2003 |
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K031038 |
06/23/2003 |
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K031393 |
06/24/2003 |
BAYER ADVIA CENTAUR CA 19-9 ASSAY |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K031644 |
06/25/2003 |
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K031682 |
06/25/2003 |
LIPOPROTEIN CALIBRATOR |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K031429 |
06/06/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML |
BD DIAGNOSTIC SYSTEMS |
KATHRYN B POWERS |
| K031606 |
06/20/2003 |
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031506 |
06/02/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031200 |
06/24/2003 |
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE |
BECTON DICKINSON & CO. |
CYNTHIA LACATENA |
| K031306 |
06/02/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K023955 |
06/24/2003 |
BD VIPER INSTRUMENT |
BECTON, DICKINSON & CO. |
COLLEN A KISTLER |
| K024057 |
06/18/2003 |
CURAD SCAR THERAPY |
BEIERSDORF, INC. |
FRANCES K WU |
| K030708 |
06/25/2003 |
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
| K031231 |
06/18/2003 |
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS |
BIO-RAD |
ELIZABETH PLATT |
| K030682 |
06/27/2003 |
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 |
BIOFORM, INC. |
WILLIAM G HUBBARD |
| K030700 |
06/04/2003 |
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K024323 |
06/30/2003 |
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 |
BIOMEDICAL SYSTEMS CORP. |
K. MICHAEL KROEHNKE |
| K030950 |
06/16/2003 |
VIDAS TROPONIN I (TNI), MODEL 30 445 |
BIOMERIEUX, INC. |
Nancy Weaver |
| K030710 |
06/04/2003 |
BIO-MODULAR SHOULDER SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K030861 |
06/12/2003 |
HA PMI FLANGED ACETABULAR COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K030332 |
06/06/2003 |
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 |
BIONICARE MEDICAL TECHNOLOGIES, INC. |
KENT HOFFMAN |
| K030951 |
06/06/2003 |
TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P |
BISCO, INC. |
STEPHEN (STEVE) SMITH |
| K030197 |
06/12/2003 |
BLACKSTONE POSTERIOR CERVICAL SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K030581 |
06/26/2003 |
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K030744 |
06/27/2003 |
BLACKSTONE SURGICAL TITANIUM MESH |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K031527 |
06/05/2003 |
MODIFICATION TO CAVERMAP SURGICAL AID |
BLUE TORCH MEDICAL TECHNOLOGIES |
FREDERICK TOBIA |
| K031538 |
06/27/2003 |
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K023691 |
06/04/2003 |
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC |
BOSTON SCIENTIFIC EPI |
TIMOTHY J JOHNSON |
| K024192 |
06/11/2003 |
VECTORVISION FLUORO3D |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K031466 |
06/11/2003 |
IQMARK DIGITAL HOLTER |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
| K031773 |
06/24/2003 |
ENDO GATOR SYSTEM |
BYRNE MEDICAL, INC. |
J. HARVEY KNAUSS |
| K030020 |
06/16/2003 |
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER |
C.R. BARD, INC. |
GLENN NORTON |
| K031000 |
06/03/2003 |
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 |
C.R. BARD, INC. |
DEBORAH L HERRINGTON |
| K031633 |
06/11/2003 |
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C |
CANON U.S.A., INC. |
SHEILA DRISCOLL |
| K031629 |
06/06/2003 |
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI |
CANON U.S.A., INC. |
SHEILA DRISCOLL |
| K031468 |
06/20/2003 |
TEMPORARY TITANIUM ANEURYSM CLIP |
Cardinal Health |
LANCE MACRCONI |
| K023036 |
06/19/2003 |
CARE ETS |
CARE REHAB AND ORTHOPAEDIC |
CHRISTIAN E HUNT |
| K031521 |
06/27/2003 |
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K031522 |
06/27/2003 |
SOLO-CARE PLUS MULTIPURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K030528 |
06/17/2003 |
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) |
CLINICAL DATA |
WYNN STOCKING |
| K030636 |
06/05/2003 |
C-PORT |
CLINISURG VASCULAR PRODUCTS, LLC |
DONALD F HULTS |
| K023817 |
06/25/2003 |
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 |
CLIO DESIGNS, INC. |
BERNARD FABRICANT |
| K030578 |
06/24/2003 |
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
CATHY STUPAK |
| K031382 |
06/30/2003 |
MODIFICATION TO HERMES O.R. CONTROL CENTER |
COMPUTER MOTION, INC. |
KEITH LOWREY |
| K030718 |
06/05/2003 |
SCB COMPUTER MOTION INTERFACE CONTROLLER |
COMPUTER MOTION, INC. |
KEITH LOWREY |
| K030807 |
06/09/2003 |
CARIES INDICATOR |
CONFI-DENTAL PRODUCTS CO. |
STEPHEN RUDOLPH |
| K031766 |
06/26/2003 |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K031058 |
06/13/2003 |
CORD STICK MULTIPLE DRAW SYSTEM |
CORD STICK CORP. |
MICHAEL MOEN |
| K031197 |
06/16/2003 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K030963 |
06/20/2003 |
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
CORDIS NEUROVASCULAR, INC. |
ALINA CARABALLO |
| K024372 |
06/19/2003 |
CP MEDICAL BONE WAX |
CP MEDICAL |
SUE RIDGE |
| K022906 |
06/11/2003 |
RESQPOD CIRCULATORY ENHANCER |
CPRX LLC |
JOHN F STAPLETON |
| K031488 |
06/04/2003 |
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K031135 |
06/02/2003 |
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) |
DADE BEHRING, INC. |
LORRAINE PIESTRAK |
| K031004 |
06/06/2003 |
SYVA EMIT II PLUS AMPHETAMINES ASSAY |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K031825 |
06/20/2003 |
C.CAM |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS SORENSEN |
| K031569 |
06/10/2003 |
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX |
DATASCOPE CORP. |
JOANN TAYLOR |
| K031653 |
06/20/2003 |
DATEX-OHMEDA HMEF 750 |
DATEX-OHMEDA |
JOEL C KENT |
| K030990 |
06/25/2003 |
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR |
DATEX-OHMEDA |
JOEL KENT |
| K031781 |
06/25/2003 |
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
| K031479 |
06/06/2003 |
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 |
DATEX-OHMEDA, INC. |
AL VAN HOUDT |
| K031027 |
06/26/2003 |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) |
DATEX-OHMEDA, INC. |
WILLIAM E EXNER |
| K023028 |
06/18/2003 |
DEMETECH NYLON NONABSORBABLE SUTURE |
DEMETECH CORP. |
LUIS ARGUELLO |
| K023030 |
06/18/2003 |
DEMETECH POLYESTER NONABSORBABLE SUTURE |
DEMETECH CORP. |
LUIS ARGUELLO |
| K030546 |
06/02/2003 |
CRP (II) CALIBRATORS |
DENKA SEIKEN CO., LTD. |
TOSHIMI MATSUNAGA |
| K030545 |
06/02/2003 |
CRP-LATEX (II)X2 SEIKEN ASSAY KIT |
DENKA SEIKEN CO., LTD. |
TOSHIMI MATSUNAGA |
| K030641 |
06/10/2003 |
CONTEC LIGHT |
DENTAURUM |
JAN W A. DOORSCHODT |
| K031635 |
06/23/2003 |
DEPUY ACROMED VBR SYSTEM |
DEPUY ACROMED |
LISA GILMAN |
| K031495 |
06/11/2003 |
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
KARLA A HAM |
| K023591 |
06/18/2003 |
ULTRA HIGH PRESSURE INJECTOR LINES |
DEROYAL INDUSTRIES, INC. |
GRACIE GREENWAY |
| K030035 |
06/25/2003 |
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
| K031159 |
06/25/2003 |
CALIBRATING MATERIAL, CALIBRATING STANDARDS |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
| K031311 |
06/20/2003 |
INTEGRADWEB BY DYNAMIC IMAGING, INC. |
DYNAMIC IMAGING INC. |
CARL ALLETTO |
| K031571 |
06/19/2003 |
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 |
E-Z-EM, INC. |
STEVEN HARTMAN |
| K031423 |
06/27/2003 |
EBI P148 SPINAL FIXATION SYSTEM |
EBI, L.P. |
JON CAPARETTA |
| K031645 |
06/25/2003 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
ART KAUFMAN |
| K030944 |
06/20/2003 |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K030800 |
06/11/2003 |
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES |
ELETROMED, INC. |
LYDIA BAYNES |
| K031113 |
06/10/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K031026 |
06/27/2003 |
ETI BIPOLAR HEMOSTATIC PROBE |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
| K031864 |
06/24/2003 |
NITREX NITINOL GUIDEWIRE |
EV3 CORPORATION |
CAROLYN ANDERSON |
| K023559 |
06/12/2003 |
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
KEVIN SHERLOCK |
| K023670 |
06/12/2003 |
SINGLE USE ORAL MASK, MODEL HC455A |
FISHER & PAYKEL HEALTHCARE, LTD. |
ROBERT PETRY |
| K024243 |
06/20/2003 |
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 |
FOX HOLLOW TECHNOLOGIES |
SUZON LOMMEL |
| K023080 |
06/11/2003 |
GALIX PACESTAR |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
JORDAN GAVRIELIDES |
| K023355 |
06/24/2003 |
ASYRA |
GALLOWAY TECHNOLOGIES, LLC |
JOE GALLOWAY |
| K031871 |
06/20/2003 |
AUTOBONE |
GE MEDICAL SYSTEMS EUROPE |
LARRY KROGER |
| K031663 |
06/09/2003 |
GE VIVID 7, MODEL FC0003XX |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K030174 |
06/19/2003 |
GENICON LAPAROSCOPES |
GENICON, LC |
GARY HABERLAND |
| K022926 |
06/06/2003 |
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 |
GENTEEL TECHNOLOGY CO., LTD. |
JENNIFER REICH |
| K031150 |
06/23/2003 |
HEMOBAG, MODEL HBBSD2000 |
GLOBAL BLOOD RESOURCES, LLC |
KEITH SAMOLYK |
| K031151 |
06/26/2003 |
TS3 TUBING SET |
GLOBAL BLOOD RESOURCES, LLC |
KEITH SAMOLYK |
| K031302 |
06/27/2003 |
SUSTAIN SPACER |
GLOBUS MEDICAL INC. |
DANIEL S PAUL |
| K031104 |
06/10/2003 |
POWDERED VINYL EXAM GLOVES, WHITE |
GLORMED INTL., INC. |
JANNA P TUCKER |
| K031505 |
06/25/2003 |
RAPIDO CUT-AWAY GUIDING CATHETER |
GUIDANT CORPORATION |
SHAH M HILALI |
| K023898 |
06/18/2003 |
GYNE IDEAS MINITAPE RP DEVICE |
GYNE IDEAS LTD. |
LOUIS MAZZARESE |
| K014013 |
06/25/2003 |
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM |
H & W TECHNOLOGY, LLC |
CHARLES O HANCOCK |
| K030824 |
06/04/2003 |
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 |
HAKKO MEDICAL CO., LTD. |
ELIZABETH MILLER |
| K030519 |
06/10/2003 |
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS |
HAND BIOMECHANICS LAB, INC. |
TIMOTHY R STALLINGS |
| K030822 |
06/03/2003 |
7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS |
HANS RUDOLPH, INC. |
KEVIN RUDOLPH |
| K030727 |
06/05/2003 |
POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT |
HEALEX PRODUCTS, INC. |
MILTON HODOSH |
| K031101 |
06/16/2003 |
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 |
HEMAGEN DIAGNOSTICS, INC. |
JOSE MONTANEZ |
| K030946 |
06/19/2003 |
HEMCON BANDAGE OTC; HEMCON CATH/AID |
HEMCON, INC. |
JAMES F HENSEL |
| K030765 |
06/09/2003 |
HOBBS MISTIFIER SPRAY CATHETER |
HOBBS MEDICAL, INC. |
ROB WHALEN |
| K030948 |
06/17/2003 |
VMATE MODEL VMM1000 |
HOWARD INSTRUMENTS, INC. |
JACK HOWARD |
| K030211 |
06/13/2003 |
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 |
ICN BIOMEDICALS, INC. |
CHARKES C.F. YU |
| K024189 |
06/20/2003 |
NLITE SYSTEM, MODEL#: A00-1025/A00-1033 |
ICN PHOTONICS LTD. |
MIKE KIERMAN |
| K030900 |
06/19/2003 |
INION OTPS BIODEGRADABLE FIXATON SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K030887 |
06/13/2003 |
LEKTROGEL, MODEL LK3001 |
INMED LTDA. |
JAY MANSOUR |
| K031450 |
06/25/2003 |
QUANTA PLEX ENA PROFILE 6 |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K030964 |
06/06/2003 |
CALIBRATION PLASMA LMW HEPARIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K030965 |
06/06/2003 |
CONTROL PLASMA LMW HEPARIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K031583 |
06/16/2003 |
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 |
INTEGRATED VASCULAR SYSTEMS, INC. |
SUSAN TURNER |
| K031096 |
06/24/2003 |
MODIFICATION TO TRANSPORT INCUBATOR 185 |
INTERNATIONAL BIOMEDICS, INC. |
GERALD MANNING |
| K024270 |
06/24/2003 |
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 |
INTERSURGICAL, INC. |
THOMAS R GUNERMAN |
| K030761 |
06/09/2003 |
KAISHOU VAGINAL SPECULUM |
JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD |
GONG BO |
| K031346 |
06/23/2003 |
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 |
JOMED, INC. |
LORRY W HUFFMAN |
| K030687 |
06/27/2003 |
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K030848 |
06/02/2003 |
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX |
KARL STORZ ENDOSCOPY |
PAUL S LEE |
| K031540 |
06/30/2003 |
APEX ELECTRIC HANDPIECE SYSTEM |
LARES RESEARCH, INC. |
JOHN DAHLGREN |
| K031098 |
06/04/2003 |
3-CCD DIGITAL CAMERA SYSTEM |
LINVATEC CORP. |
LAURA D SENEFF |
| K030720 |
06/03/2003 |
ULTRABLATOR ELECTRODE |
LINVATEC CORP. |
LAURA D SENEFF |
| K031443 |
06/18/2003 |
LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS |
LSI SOLUTIONS |
CHRISTOPHER A KLACZYK |
| K031005 |
06/18/2003 |
LUMEND FRONTRUNNER GW CTO CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K024093 |
06/19/2003 |
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS |
LUMENIS, LTD. |
ANNE WORDEN |
| K031594 |
06/06/2003 |
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY |
M.K. MEDITECH CO. LTD. |
ROSINA ROBINSON |
| K021360 |
06/10/2003 |
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 |
MED-TEC,INC. |
DONALD F RIIBE |
| K031614 |
06/06/2003 |
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP |
MEDELA, INC. |
CHRISTOPHER L PETERSON |
| K030218 |
06/23/2003 |
PER, MODEL MEMO |
MEDICAL MONITORS PTY., LTD. |
HARRY L PLATT |
| K031486 |
06/27/2003 |
BLASTFREEZE AND BLASTTHAW |
MEDICULT A/S |
RONALD G LEONARDI |
| K031228 |
06/24/2003 |
SYNVITRO HYADASE |
MEDICULT A/S |
RONALD G LEONARDI |
| K031886 |
06/30/2003 |
SONOVIEW PRO BY MEDISON CO., LTD. |
MEDISON CO., LTD. |
CARL ALLETTO |
| K031888 |
06/27/2003 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K030816 |
06/06/2003 |
MSD CABLE REDUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K031655 |
06/27/2003 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE, PHD |
| K030875 |
06/24/2003 |
MODIFICATION TO COLORADO 2 SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K031533 |
06/13/2003 |
VANTAGE ANTERIOR FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K031510 |
06/18/2003 |
NIM-SPINE |
MEDTRONIC XOMED |
MARTIN SARGENT |
| K030104 |
06/11/2003 |
PRIME ECG SYSTEM |
MERIDIAN MEDICAL TECHNOLOGIES, INC. |
JAMIL LAHAM |
| K030330 |
06/20/2003 |
CTXA HIP EXTENDED REFERENCE DATA |
MINDWAYS SOFTWARE, INC. |
CHRISTOPHER CANN |
| K030531 |
06/17/2003 |
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER |
MINIMED, INC. |
GERDA P RESCH |
| K031248 |
06/20/2003 |
CONSULTIVA REPORT STATION, MODEL RS-1 |
MIRAMEDICA, INC |
WIDO MENHARDT |
| K031519 |
06/06/2003 |
CUFFLOK ANCHOR |
MITEK WORLDWIDE |
RUTH C FORSTADT |
| K030995 |
06/26/2003 |
MINILOK QUICKANCHOR PLUS |
MITEK WORLDWIDE |
RUTH C FORSTADT |
| K031131 |
06/10/2003 |
KLINIDRAPE SURGICAL DRAPES |
MOLNLYCKE HEALTH CARE |
LINDA A HENDRICKS |
| K030913 |
06/03/2003 |
NANMA VACUUM PUMP |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
| K031627 |
06/11/2003 |
NANO-TICROWN |
NANO-WRITE CORP. |
KENNETH E KNAPP |
| K023367 |
06/25/2003 |
DETECTAR, MODEL N123-MI |
NEKS TECHNOLOGIES |
CHARLES H KYPER |
| K024259 |
06/20/2003 |
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K021328 |
06/26/2003 |
SMART BAG MO |
O-TWO SYSTEMS INTERNATIONAL INC. |
KEVIN BOWDEN |
| K030401 |
06/19/2003 |
DISPOSABLE M2-PE MICROKERATOME BLADES |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
| K031391 |
06/20/2003 |
HF MODULE WITH TRANSDUCERS |
OPHTHALMIC TECHNOLOGIES, INC. |
GEORGE MYERS |
| K031083 |
06/12/2003 |
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 |
OPUS MEDICAL, INC. |
JAMES W HART |
| K023378 |
06/27/2003 |
ORIA CLARIS |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K031452 |
06/18/2003 |
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K031164 |
06/19/2003 |
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV |
Oscor Inc. |
MILA DOCKOCIL |
| K023011 |
06/26/2003 |
OSMONICS SOLUTION DELIVERY SYSTEM |
OSMONICS MEDICAL SYSTEMS |
KRISTINE KALISZEWSKI |
| K030608 |
06/12/2003 |
OTI BONE CEMENT PLUG |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K024179 |
06/04/2003 |
PALOMAR LIGHTCUBE |
PALOMAR MEDICAL PRODUCTS, INC. |
Marcy Moore |
| K030863 |
06/27/2003 |
EBV VCA-P18 IGG ELISA |
PANBIO LIMITED |
HELEN JENNINGS |
| K031205 |
06/13/2003 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K031103 |
06/12/2003 |
PASCO MIC AND MIC/ID PANELS (ERTAPENEM) |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K030987 |
06/12/2003 |
CONTACT LENS STORAGE CASE |
PELICAN PRODUCTS |
CAROL NOBEL |
| K031023 |
06/27/2003 |
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K031021 |
06/13/2003 |
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K031414 |
06/26/2003 |
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K031591 |
06/26/2003 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K031535 |
06/17/2003 |
PHILIPS EASYDIAGNOST ELEVA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
| K031095 |
06/20/2003 |
SENSE BODY COIL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE C PRASCHAN |
| K030883 |
06/18/2003 |
OMNILUX BLUE |
PHOTO THERAPEUTICS LIMITED |
MAUREEN O'CONNELL |
| K023333 |
06/23/2003 |
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR |
PLEASURE LATEX PRODUCTS SDN. BHD. |
KOI-YONG LIM |
| K031165 |
06/06/2003 |
PLUS ORTHOPEDICS CEMENTED HIP STEM |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K031622 |
06/26/2003 |
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS |
PORTEX LTD. |
STEVE OGILVIE |
| K031680 |
06/24/2003 |
SPECTRAPULSE |
PRIMARY TECHNOLOGY, LLC. |
STEPHEN ALMEIDA |
| K030445 |
06/05/2003 |
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM |
PRIMUS GLOVES PRIVATE LTD. |
JOSEPH J.E. PEREIRA |
| K030444 |
06/05/2003 |
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES |
PRIMUS GLOVES PRIVATE LTD. |
JOSEPH J.E. PEREIRA |
| K024181 |
06/26/2003 |
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM |
PRIZM MEDICAL, INC. |
CATHRYN N CAMBRIA |
| K031409 |
06/17/2003 |
URINARY CATHETERS |
PROMEDIC, INC. |
PAUL DRYDEN |
| K031754 |
06/30/2003 |
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE |
PT. MANDIRI INTI BUANA |
NG POY SIN |
| K023335 |
06/18/2003 |
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) |
QC SCIENCES, LLC |
JUNQI QIAN |
| K030535 |
06/11/2003 |
EKGCARD SYSTEM |
QRS DIAGNOSTIC, LLC. |
BRAD SORENSON |
| K031662 |
06/06/2003 |
PRESSURE WIRE SENSOR, MODELS 12004/12304 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K030897 |
06/19/2003 |
SKINSTATION |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K031460 |
06/24/2003 |
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K023174 |
06/11/2003 |
DISPOSABLE TEMPORARY PACING WIRE |
RIVER MEDICAL, INC. |
MARY ANN GREENAWALT |
| K031756 |
06/25/2003 |
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K023666 |
06/17/2003 |
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER |
RUSCH INTL. |
RICK LYKINS |
| K030559 |
06/30/2003 |
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K031884 |
06/30/2003 |
INTERFERENTIAL STIMULATOR, MODEL NETWAVE |
RYAN TELEMEDICINE |
JIM KLETT |
| K031348 |
06/10/2003 |
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY |
SALIMETRICS LLC. |
EVE SCHWARTZ |
| K030811 |
06/10/2003 |
COOL CURE |
SAMM, INC. |
W. EDWARD JOHANSEN |
| K031010 |
06/25/2003 |
MIRACLE 98 |
SB LUCIUS, INC. |
DAE-KYU CHANG |
| K023195 |
06/03/2003 |
MAGLIFE C/MAGLIFE C PLUS |
SCHILLER MEDICAL S.A. |
COURT GOEHRY |
| K023881 |
06/13/2003 |
PROFILE 1064 LASER SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K030994 |
06/12/2003 |
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS |
SGMP CO., LTD. |
JANNA P TUCKER |
| K030993 |
06/12/2003 |
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS |
SGMP CO., LTD. |
JANNA P TUCKER |
| K021993 |
06/03/2003 |
SHANCHUAN SYRINGE |
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. |
HAIRONG CHE |
| K023940 |
06/04/2003 |
SHELHIGH BIORING |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K030640 |
06/03/2003 |
SIEMENS MICRO2+ WITH VAI SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K030738 |
06/06/2003 |
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K031154 |
06/24/2003 |
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X |
SINTEA BIOTECH, INC. |
MARIANNE GRUNWALDT |
| K021979 |
06/27/2003 |
SMISSON STABILIZATION SYSTEM |
SMISSON-CARTLEDGE |
GRACE HOLLAND |
| K031605 |
06/18/2003 |
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K031675 |
06/20/2003 |
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
| K030842 |
06/06/2003 |
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
| DEN030002 |
06/16/2003 |
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
SPECTRAL DIAGNOSTICS, INC. |
TOM TSAKERIS |
| K022393 |
06/05/2003 |
MERDOC SYSTEM |
Stryker Endoscopy |
KIRAN JAVADEKAR |
| K022579 |
06/02/2003 |
STRYKER NAVIGATION SYSTEM-KNEE MODULE |
STRYKER LEIBINGER |
KELLI J BITTERBURG |
| K030891 |
06/17/2003 |
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK |
SURGISTAR, INC. |
JONATHAN WOODWARD |
| K031609 |
06/09/2003 |
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM |
SWISS ORTHOPEDIC SOLUTIONS INC |
BOB BENNETT |
| K031573 |
06/06/2003 |
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE |
SYNTHES (USA) |
BONNIE J SMITH |
| K031725 |
06/24/2003 |
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM |
SYNTHES (USA) |
BONNIE SMITH |
| K031065 |
06/23/2003 |
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 |
SYRINGEX MEDICAL, INC. |
JOHN JONES |
| K031188 |
06/27/2003 |
ORTHOMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K024010 |
06/11/2003 |
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER |
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP |
DAVID A OLSON |
| K031470 |
06/05/2003 |
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US |
TYCO HEALTHCARE NANCY |
JAMES BONDS |
| K031595 |
06/24/2003 |
U & I AMERICA SPINAL HOOK SYSTEM |
U&I CORP., AMERICA |
PATRICK MOORE |
| K031585 |
06/27/2003 |
U&I, OPTIMA, SPINAL SYSTEM |
U&I CORP., AMERICA |
PATRICK MOORE |
| K023430 |
06/24/2003 |
UF BRACHYTHERAPY STAND |
UNIVERSITY OF FLORIDA |
PATSY J TRISLER |
| K030981 |
06/24/2003 |
ECLIPSE |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K030654 |
06/18/2003 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
DEBORAH JENSEN |
| K031015 |
06/23/2003 |
EMBRYOGLUE |
VITROLIFE SWEDEN AB |
NINA ARVIDSSON |
| K031556 |
06/23/2003 |
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K030844 |
06/13/2003 |
FINAL VARNISH LC |
VOCO GMBH |
GERALD W SHIPPS |
| K030916 |
06/19/2003 |
UFI GEL HARD C |
VOCO GMBH |
GERALD W SHIPPS |
| K024280 |
06/06/2003 |
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K031696 |
06/17/2003 |
LORENZE EXTERNAL MANDIBULAR DISTRACTOR |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K031751 |
06/26/2003 |
RAPIDFIRE SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K030838 |
06/27/2003 |
WARTNER PRO |
WARTNER MEDICAL PRODUCTS |
NANCY LUM-WILSON |
| K031326 |
06/17/2003 |
IMAGINE REFLEX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K031264 |
06/12/2003 |
PORTA PRESSOVER |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K023755 |
06/10/2003 |
WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD |
WINNER INDUSTRIES (SHENZHEN) CO., LTD. |
MING XIE |
| K031014 |
06/27/2003 |
HI-FLO THERME PNEU 45, WISAP #7083, 7083V |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
HORST SEMM |
| K022705 |
06/09/2003 |
READI-STRAND, MODEL PSSTRAND |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
| K031130 |
06/27/2003 |
YA MEI FIRST AID KIT |
YA MEI TECHNOLOGY CO., LTD. |
Kevin Walls |
| K031384 |
06/17/2003 |
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K030724 |
06/03/2003 |
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM |
ZIMMER, INC. |
KAREN CAIN |
| K031572 |
06/24/2003 |
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 |
ZIMMER, INC. |
KAREN CAIN |
| K030605 |
06/27/2003 |
RAPID IMF |
ZYGOMATICS LTD. |
CAROL MACDONALD |
