| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K031263 |
04/24/2003 |
3M LIQUID BANDAGE, MODEL 120-LB |
3M COMPANY |
ANNA E MCRIGHT |
| K031287 |
04/28/2003 |
STERI-DRAPE SURGICAL DRAPES |
3M COMPANY |
SCOTT S SARDESON |
| K031350 |
04/29/2003 |
3TP SOFTWARE OPTION |
3TP LLC |
VINCENT J MCGILL |
| K031353 |
04/29/2003 |
SOLUTION FACE MASKS |
A PLUS INTERNATIONAL, INC |
SOLOMON CHEN |
| K031260 |
04/25/2003 |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 |
ABBOTT DIABETES CARE INC. |
DONNA K TEMPLEMAN |
| K031185 |
04/15/2003 |
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
| K031331 |
04/28/2003 |
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM |
ABBOTT VASCULAR INC. |
JOANNA KUSKOWSKI |
| K031048 |
04/16/2003 |
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K031052 |
04/16/2003 |
CARESTART HCG ONE-STEP PREGNANCY TEST |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K031226 |
04/21/2003 |
STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K031198 |
04/25/2003 |
SCANX 10 |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K031193 |
04/16/2003 |
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION |
ALCON, INC. |
KIM B KRACKE |
| K031273 |
04/23/2003 |
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE |
AMERTEK MEDICAL, INC. |
GREG WIITA |
| K031110 |
04/10/2003 |
APEX MODULAR ACETABULAR CUP |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K031153 |
04/11/2003 |
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 |
ARROW INTL., INC. |
WILLIAM G MCLAIN |
| K031141 |
04/30/2003 |
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE |
ASAP ENDOSCOPIC PRODUCTS GMBH |
MARTINA GUNDEROTH |
| K031319 |
04/25/2003 |
OSTEO-G BONE VOID FILLER SYSTEM |
ASPINE USA, INC. |
FLOYD G LARSON |
| K031177 |
04/29/2003 |
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K031041 |
04/06/2003 |
FLUENCY TRACHEOBRONCHIAL STENT GRAFT |
BARD PERIPHERAL VASCULAR |
AYMEE R BERRY |
| K031038 |
04/04/2003 |
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K031270 |
04/22/2003 |
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031297 |
04/24/2003 |
ACCESS OV MONITOR ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031269 |
04/22/2003 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031306 |
04/24/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K031352 |
04/30/2003 |
BIO-LOGIC INSERT EARPHONES |
BIO-LOGIC SYSTEMS CORP. |
ERIK C GUNDERSEN |
| K031231 |
04/29/2003 |
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS |
BIO-RAD |
ELIZABETH PLATT |
| K031296 |
04/23/2003 |
LIQUI-HEME GLYCO A1C ASSAY |
BIODIAGNOSTIC INTL |
PAUL ANAND |
| K031337 |
04/28/2003 |
ACUMEN SURGICAL NAVIGATION SYSTEM |
BIOMET, INC. |
KRISTINE C ARNOLD |
| K031334 |
04/29/2003 |
TEXAS T - PLATE |
BIOMET, INC. |
GARY BAKER |
| K031280 |
04/22/2003 |
ULTRA-DRIVE 3 |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K031028 |
04/09/2003 |
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
| K031161 |
04/14/2003 |
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WILLIAM WELCH |
| K031118 |
04/09/2003 |
INTRAOS 70 |
BLUE X IMAGING SRL |
AL SOSA |
| K031049 |
04/14/2003 |
GUGLIELMI DETACHABLE COIL (GDC) |
BOSTON SCIENTIFIC, TARGET |
ROXANE BAXTER |
| K031168 |
04/14/2003 |
MATRIX STRETCH RESISTANT DETACHABLE COIL |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K031202 |
04/16/2003 |
MEDIPALM-20 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K031295 |
04/23/2003 |
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM |
C.R. BARD, INC. |
FRANCES E HARRISON |
| K031332 |
04/29/2003 |
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH |
C.R. BARD, INC. |
TERRINA WILDER |
| K031186 |
04/15/2003 |
LUMINEXX ENDOSCOPIC BILIARY STENT |
C.R. BARD, INC. |
THOMAS HIRTE |
| K031129 |
04/09/2003 |
POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K031328 |
04/28/2003 |
RECOVERY FILTER SYSTEM, MODEL RF-048F |
C.R. BARD, INC. |
MARY J EDWARDS |
| K031272 |
04/30/2003 |
C.T.M. MOBILITY SCOOTER, MODEL HS-120 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K031301 |
04/24/2003 |
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING |
CARDINAL HEALTH |
ERICA SETHI |
| K031207 |
04/23/2003 |
SAFETY RELEASE ARCH BAR KIT |
CASEY SURGICAL, LLC |
JAMES E STANLEY |
| K031183 |
04/15/2003 |
TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE |
CENTERPULSE ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K031042 |
04/30/2003 |
ATAC HEMOGLOBIN A1C REAGENT KIT |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K031044 |
04/30/2003 |
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K031123 |
04/14/2003 |
CODMAN BACTISEAL BARIUM STRIPED CATHETERS |
CODMAN & SHURTLEFF, INC. |
ELIZABETH DOLAN |
| K031069 |
04/08/2003 |
SURGISIS NERVE CUFF |
COOK BIOTECH, INC. |
MARK BLEYER |
| K031304 |
04/25/2003 |
SYDNEY IVF PVP |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
| K031058 |
04/09/2003 |
CORD STICK MULTIPLE DRAW SYSTEM |
CORD STICK CORP. |
MICHAEL MOEN |
| K031197 |
04/16/2003 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K031258 |
04/23/2003 |
CYNOSURE PHOTOLIGHT PL |
CYNOSURE, INC. |
GEORGE CHO |
| K031125 |
04/23/2003 |
CYNOSURE SMART FILE ND:YAG LASERS |
CYNOSURE, INC. |
GEORGE CHO |
| K031317 |
04/25/2003 |
SMART 2940 D ER: YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K031224 |
04/23/2003 |
SMARTXIDE |
CYNOSURE, INC. |
GEORGE CHO |
| K031135 |
04/09/2003 |
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) |
DADE BEHRING, INC. |
LORRAINE PIESTRAK |
| K031343 |
04/29/2003 |
TPSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K031027 |
04/29/2003 |
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) |
DATEX-OHMEDA, INC. |
WILLIAM E EXNER |
| K031124 |
04/08/2003 |
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR |
DATEX-OHMEDA, INC. |
AL VAN HOUDT |
| K031074 |
04/08/2003 |
DIGITAL AMBULATORY ECG (HOLTER) RECORDER |
DATRIX |
LAUREN M LUHMANN |
| K031213 |
04/17/2003 |
AQUASENS FLUID MONITORING SYSTEM |
DAVOL, INC. |
BRIAN A KANERVIKO |
| K031145 |
04/16/2003 |
ESTYLUS ELECTRIC MOTOR SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K031203 |
04/16/2003 |
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN |
| K031223 |
04/21/2003 |
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K031311 |
04/30/2003 |
INTEGRADWEB BY DYNAMIC IMAGING, INC. |
DYNAMIC IMAGING INC. |
CARL ALLETTO |
| K031329 |
04/28/2003 |
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) |
DYNATRONICS CORP. |
RON HATCH |
| K031132 |
04/29/2003 |
CONSULTIVA CASE INPUT STATION, MODEL CIS-1 |
EASTMAN KODAK COMPANY |
WIDO MENHARDT |
| K031354 |
04/30/2003 |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K031355 |
04/30/2003 |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K031093 |
04/11/2003 |
EBI XFIX OPTIROM KNEE FIXATOR |
EBI, L.P. |
JON CAPAROTTA |
| K031045 |
04/30/2003 |
AEROLET TOILET LIFT, MODEL AER-01 |
ECONOMIC HOLLAND B.V. |
STEPHANIE WOLFKAMP |
| K031087 |
04/10/2003 |
EDWARDS INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
DAUN PUTNAM |
| K031113 |
04/17/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K031134 |
04/22/2003 |
DISPOSABLE POWDERED VINYL EXAM GLOVES |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K031367 |
04/30/2003 |
DUOPATH VEROTOXINS GLISA TEST |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
| K031066 |
04/06/2003 |
VIEWMATE ULTRASOUND IMAGING SYSTEM |
EP MEDSYSTEMS |
JOHN J TALARICO |
| K031147 |
04/10/2003 |
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY SHOEMAKER |
| K031195 |
04/17/2003 |
CUF-COVER (TM) |
ETHOX CORP. |
DANIEL KAMM |
| K031292 |
04/23/2003 |
MODIFICATION TO FOSSA URETERAL STONE SWEEPER |
FOSSA MEDICAL, INC. |
PAMELA PAPINEAU |
| K031117 |
04/23/2003 |
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM |
GALIL MEDICAL LTD. |
RONI ZVULONI |
| K031261 |
04/21/2003 |
CARD EP |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K031230 |
04/18/2003 |
GE PROPELLER IMAGING OPTION FOR MRI |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K031320 |
04/25/2003 |
EK-PRO ARRHYTHMIA DETECTION ALGORITHM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
| K031036 |
04/21/2003 |
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 |
GEBAUER CO. |
AMY J PAUKOVITS |
| K031259 |
04/22/2003 |
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER |
GETINGE USA, INC |
FREDERICK R CATT |
| K031300 |
04/25/2003 |
IBC FLOPUMP WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K031033 |
04/15/2003 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K031150 |
04/22/2003 |
HEMOBAG, MODEL HBBSD2000 |
GLOBAL BLOOD RESOURCES, LLC |
KEITH SAMOLYK |
| K031151 |
04/22/2003 |
TS3 TUBING SET |
GLOBAL BLOOD RESOURCES, LLC |
KEITH SAMOLYK |
| K031302 |
04/29/2003 |
SUSTAIN SPACER |
GLOBUS MEDICAL INC. |
DANIEL S PAUL |
| K031104 |
04/30/2003 |
POWDERED VINYL EXAM GLOVES, WHITE |
GLORMED INTL., INC. |
JANNA P TUCKER |
| K031082 |
04/24/2003 |
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK |
GYRUS MEDICAL, INC. |
MERCEDES P BAYANI |
| K031080 |
04/24/2003 |
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS |
GYRUS MEDICAL, INC. |
MERCEDES BIRYANI |
| K031078 |
04/24/2003 |
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS |
GYRUS MEDICAL, INC. |
MERCEDES P BAYANI |
| K031079 |
04/24/2003 |
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K031081 |
04/24/2003 |
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K031085 |
04/24/2003 |
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K031101 |
04/15/2003 |
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 |
HEMAGEN DIAGNOSTICS, INC. |
JOSE MONTANEZ |
| K031217 |
04/18/2003 |
GMRS PRESS FIT STEMS WITH PUREFIX HA |
HOWMEDICA OSTEONICS |
MARGARET F CROWE |
| K031090 |
04/07/2003 |
MODIFICATION TO XIA STAINLESS STEEL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K031127 |
04/10/2003 |
ORTHOPEDIC WIRE |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K031122 |
04/08/2003 |
HEMOSIL FACTOR X DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K031373 |
04/30/2003 |
IXL DIABETES MANAGEMENT SYSTEM |
INSULET CORP. |
A. ARTHUR RANKIS |
| K031096 |
04/29/2003 |
MODIFICATION TO TRANSPORT INCUBATOR 185 |
INTERNATIONAL BIOMEDICS, INC. |
GERALD MANNING |
| K031064 |
04/04/2003 |
INVACARE POLARIS EX CPAP, MODEL ISP3000 |
INVACARE CORP. |
JANICE BROWNLEE |
| K031176 |
04/14/2003 |
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 |
INVACARE CORP. |
RAE ANN FARROW |
| K031115 |
04/11/2003 |
RH-900 |
IOMED, INC. |
CURTIS JENSEN |
| K031148 |
04/28/2003 |
IN-VISION IMAGING SYSTEM |
JOMED, INC. |
LORRAINE W HUFFMAN |
| K031346 |
04/30/2003 |
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 |
JOMED, INC. |
LORRY W HUFFMAN |
| K031277 |
04/28/2003 |
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 |
JOMED, INC. |
TERRY SCHULTZ |
| K031098 |
04/07/2003 |
3-CCD DIGITAL CAMERA SYSTEM |
LINVATEC CORP. |
LAURA D SENEFF |
| K031128 |
04/15/2003 |
B-SMART, MODEL B-01 |
MACOSTA MEDICAL USA, LLC |
PAMELA PAPINEAU |
| K031372 |
04/30/2003 |
PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION |
MAXXVISION, LLC |
JAMES K WALKER |
| K031119 |
04/29/2003 |
MAYO CLINIC BC-10 1.5T |
MAYO MEDICAL VENTURES |
JADE SADOSTY |
| K031228 |
04/24/2003 |
SYNVITRO HYADASE |
MEDICULT A/S |
RONALD G LEONARDI |
| K031032 |
04/15/2003 |
VERDICT II, PROFILE II |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K031211 |
04/18/2003 |
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH |
MEDTRONIC VASCULAR |
LYNN JENSEN |
| K031247 |
04/23/2003 |
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM |
MEDTRONIC VASCULAR |
SCOTT CUNDY |
| K031274 |
04/23/2003 |
MODEL 5071 MYOCARDIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K031285 |
04/23/2003 |
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K031210 |
04/18/2003 |
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD |
METRONIC, INC. |
TINA BENOIT |
| K031102 |
04/09/2003 |
MICROLAB SPIROMETER |
MICRO DIRECT, INC. |
DAVID R STASZAK |
| K031248 |
04/29/2003 |
CONSULTIVA REPORT STATION, MODEL RS-1 |
MIRAMEDICA, INC |
WIDO MENHARDT |
| K031131 |
04/24/2003 |
KLINIDRAPE SURGICAL DRAPES |
MOLNLYCKE HEALTH CARE |
LINDA A HENDRICKS |
| K031182 |
04/15/2003 |
ELI 200+ AUDICOR |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K031262 |
04/25/2003 |
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 |
NDO SURGICAL, INC. |
ERIC BANNON |
| K031184 |
04/24/2003 |
COOL TOUCH 3 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K031070 |
04/30/2003 |
CARBON FIBER BRIDGE, MODEL 28757 |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K031345 |
04/30/2003 |
NOBEL DIRECT, MODELS 30937, 30938 |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K031149 |
04/15/2003 |
OLYMPIC CFM 6000 |
OLYMPIC MEDICAL CORP. |
EDWARD B. (TED) WEILER |
| K031305 |
04/25/2003 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM |
OLYMPUS OPTICAL CO., LTD. |
TINA STEFFANIE-OAK |
| K031347 |
04/29/2003 |
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K031256 |
04/24/2003 |
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TINA STEFFANIE-OAK |
| K031083 |
04/30/2003 |
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 |
OPUS MEDICAL, INC. |
JAMES W HART |
| K031201 |
04/16/2003 |
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM |
ORTHO DEVELOPMENT CORP. |
NADEEM AHMED |
| K031031 |
04/24/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
| K031219 |
04/29/2003 |
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
ORTHOFIX, INC. |
MARY BIGGERS |
| K031156 |
04/14/2003 |
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K031187 |
04/17/2003 |
HEARTSTART MRX, MODEL M3535A |
PHILIPS MEDICAL SYSTEMS |
PETER OHANIAN |
| K031333 |
04/28/2003 |
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K031095 |
04/30/2003 |
SENSE BODY COIL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE C PRASCHAN |
| K031165 |
04/14/2003 |
PLUS ORTHOPEDICS CEMENTED HIP STEM |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K031057 |
04/21/2003 |
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT |
PORTEX, INC. |
TIMOTHY J TALCOTT |
| K031357 |
04/30/2003 |
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| K031196 |
04/16/2003 |
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM |
PRAXIM |
SHEILA HEMEON-HEYER |
| K031152 |
04/23/2003 |
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) |
PROPPER MFG. CO., INC. |
JOHN D DYCKMAN |
| K031157 |
04/21/2003 |
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
| K031206 |
04/25/2003 |
RADIOMED SOFT TISSUE MARKER |
RADIOMED CORP. |
GORDON ROBERTS |
| K031114 |
04/15/2003 |
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K031099 |
04/22/2003 |
SORB+HISORB+CARTRIDGE |
RENAL SOLUTIONS, INC. |
RICHARD G CONFER |
| K031257 |
04/21/2003 |
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR |
RITA MEDICAL SYSTEMS INC |
VICKI HACKER |
| K031348 |
04/30/2003 |
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY |
SALIMETRICS LLC. |
EVE SCHWARTZ |
| K031291 |
04/23/2003 |
CDR PANX, MODEL 4792 |
SCHICK TECHNOLOGIES, INC. |
DANIEL J SHERRATT |
| K031290 |
04/23/2003 |
MODIFICATION TO EASYS TRANSVERSE CONNECTION |
SCIENT'X USA, INC. |
J.D. WEBB |
| K031053 |
04/11/2003 |
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 |
SELECTIVE MED COMPONENTS, INC. |
RICHARD J FISHER |
| K031163 |
04/15/2003 |
SEZ SAFETY SYRINGE |
SEZ CORPORATION |
DANIEL KAMM |
| K031072 |
04/17/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
|
| K031293 |
04/24/2003 |
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K031108 |
04/22/2003 |
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| K031169 |
04/17/2003 |
MOTILITY VISUALIZATION SYSTEM |
SIERRA SCIENTIFIC INSTRUMENTS, INC. |
SEAN M CURRY |
| K031181 |
04/15/2003 |
EXTERNAL FIXATION SYSTEMS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K031371 |
04/30/2003 |
SAPHYRE BIPOLAR ABLATION PROBES |
SMITH & NEPHEW, INC. |
LINDA GUTHRIE |
| K031162 |
04/14/2003 |
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM |
SMITH & NEPHEW, INC. |
KANU VADODARIA |
| DEN030002 |
04/14/2003 |
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
SPECTRAL DIAGNOSTICS, INC. |
TOM TSAKERIS |
| K031265 |
04/28/2003 |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
SPINE NEXT SA |
DIANE JOHNSON |
| K031341 |
04/28/2003 |
STICK FLOW |
STICK TECH LTD. |
WILLIAM TROETEL |
| K031055 |
04/09/2003 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
| K031278 |
04/22/2003 |
STRYKER FLEXIBLE URETEROSCOPE |
STRYKER ENDOSCOPY |
CHRISTOPHER L COOK |
| K031068 |
04/10/2003 |
STRYKER VISUM SURGICAL LIGHTING SYSTEM |
STRYKER ENDOSCOPY |
MELISSA MURPHY |
| K031249 |
04/29/2003 |
MODIFICATION TO STRYKER PAINPUMP |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K031289 |
04/29/2003 |
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 |
SUNRISE MEDICAL, INC. |
MICHAEL CHELLSON |
| K031133 |
04/09/2003 |
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS |
SURGRX INC |
LINDA OLESON |
| K031120 |
04/22/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031076 |
04/21/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031175 |
04/25/2003 |
CLICK'X MONOAXIAL SCREWS AND HOOKS |
SYNTHES (USA) |
JOHN WALSH |
| K031178 |
04/16/2003 |
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K031276 |
04/25/2003 |
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM |
SYNTHES (USA) |
JON GILBERT |
| K031100 |
04/09/2003 |
SYNTHES VENTROFIX MIS SYSTEM |
SYNTHES (USA) |
JOHN WALSH |
| K031065 |
04/14/2003 |
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 |
SYRINGEX MEDICAL, INC. |
JOHN JONES |
| K031179 |
04/23/2003 |
TAGA VELOCITY HUMIDIFIER |
TAGA MEDICAL TECHNOLOGIES, INC. |
GARY AUSTIN |
| K031062 |
04/15/2003 |
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) |
TAIJECT MEDICAL DEVICE CO., LTD. |
JIM-SON CHOU |
| K031312 |
04/24/2003 |
RTA MODEL D RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHN |
| K031188 |
04/16/2003 |
ORTHOMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K031229 |
04/18/2003 |
TELZUIT CARDIAC MONITORING SYSTEM |
TELZUIT TECHNOLOGIES, INC. |
CYNTHIA J.M. NOLET |
| K031266 |
04/22/2003 |
SURSHIELD SAFETY WINGED INFUSION SET |
TERUMO CORP. |
BARBARA SMITH |
| K031279 |
04/22/2003 |
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET |
TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD. |
KAZUHITO INOUE |
| K031040 |
04/25/2003 |
THERIFIL BONE FILLER |
THERICS, INC. |
UMBERTO V PARROTTA, JR |
| K031218 |
04/23/2003 |
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS |
TORNIER |
MIREILLE LEMERY |
| K031088 |
04/23/2003 |
TRIMED PLAN, VERSION 2.2 |
TRIMED SYSTEMS, INC |
SHERRY ZHANG |
| K031189 |
04/15/2003 |
UUHC REPROCESSED COMPRESSION SLEEVE DEVICES |
UNIVERSITY OF UTAH HOSPITALS AND CLINICS |
JACK SPEER |
| K031143 |
04/18/2003 |
ALPHA 5000 WRIST COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031056 |
04/09/2003 |
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031139 |
04/15/2003 |
PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031172 |
04/21/2003 |
SPIRIT III TOTALSENSE CARDIAC COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031358 |
04/30/2003 |
TRANSVAGINAL DOPPLER PROBE |
VASCULAR CONTROL SYSTEMS, INC |
KATHLEEN ROBERTS |
| K031091 |
04/07/2003 |
VTI 20 MHZ GATED DOPPLER |
VASCULAR TECHNOLOGY INCORPORATED |
DAVID L REGAN |
| K031089 |
04/16/2003 |
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACY DE VAN WOLF |
| K031034 |
04/21/2003 |
SPIN DOWN RAPIDFLAP |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K031174 |
04/30/2003 |
BODY SIGNAL ECG ELECTRODE |
WANDY RUBBER INDUSTRIAL CO., LTD |
JANIS YANG |
| K031326 |
04/25/2003 |
IMAGINE REFLEX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K031264 |
04/22/2003 |
PORTA PRESSOVER |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K031130 |
04/23/2003 |
YA MEI FIRST AID KIT |
YA MEI TECHNOLOGY CO., LTD. |
KEVIN WALLS |
| K031199 |
04/18/2003 |
ENTERALITE INFINITY ENTERAL FEEDING PUMP |
ZEVEX INTL., INC. |
SEAN M CURRY |
| K031061 |
04/15/2003 |
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS |
ZIMMER, INC. |
STEPHEN MCKELVEY |
