| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K032001 |
08/11/2003 |
POLY Q (GARANT L, PENTA M, PENTA H) |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K032070 |
08/27/2003 |
ELCACAM |
A-DEC, INC. |
TOM LOUISELL |
| K031331 |
08/12/2003 |
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM |
ABBOTT VASCULAR INC. |
JOANNA KUSKOWSKI |
| K031759 |
08/04/2003 |
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K030898 |
08/27/2003 |
MOBILE BATTERY SERVICE STATION (MBSS) |
AD ELEKTRONIK GMBH |
RICHARD TOOTCHEN |
| K030429 |
08/18/2003 |
STERRAD 200 STERILIZER |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K032198 |
08/20/2003 |
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP |
AESCULAP, INC. |
MATTHEW M HULL |
| K030367 |
08/21/2003 |
COLUMBUS (PS) |
AESCULAP, INC. |
JOYCE KILROY |
| K030109 |
08/08/2003 |
ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K014241 |
08/01/2003 |
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D |
ALSIUS CORP. |
KEN COLLINS |
| K032448 |
08/22/2003 |
ALTATEC CERAMIC ABUTMENT |
ALTATEC BIOTECHNOLOGIES |
ROBERT SLOMOFF |
| K030222 |
08/19/2003 |
NX SYSTEM |
AMERICAN TELECARE, INC. |
PETE PLUCINAK |
| K021560 |
08/14/2003 |
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
AMERIWATER |
BRAIN R BOWMAN |
| K032376 |
08/26/2003 |
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K032069 |
08/27/2003 |
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K031710 |
08/29/2003 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
| K032217 |
08/21/2003 |
14G CORMARK BIOPSY SITE IDENTIFIER |
ARTEMIS MEDICAL, INC. |
LINDA GUTHRIE |
| K032504 |
08/21/2003 |
ARTHROCARE SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K031694 |
08/29/2003 |
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K013643 |
08/14/2003 |
AUSAM TOTAL ALBUMIN ASSAY |
AUSAM BIOTECTHNOLOGIES INC |
LYNN ROLAND |
| K031923 |
08/11/2003 |
ULTRASITE VALVE |
B. BRAUN MEDICAL, INC. |
SHERI L MUSGNUNG |
| K032261 |
08/22/2003 |
Trellis Reserve Infusion System |
BACCHUS VASCULAR, INC. |
GREGORY J MATHISON |
| K031566 |
08/19/2003 |
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
| K031683 |
08/06/2003 |
TOX AMMONIA CALIBRATOR |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K030407 |
08/19/2003 |
ADVISOR, MODEL 9200 |
BCI, INC. |
DONALD ALEXANDER |
| K031742 |
08/18/2003 |
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER |
BCI, INC. |
DONALD J ALEXANDER |
| K032259 |
08/19/2003 |
PASCO MIC AND MIC/ID PANELS |
BD DIAGNOSTIC SYSTEMS |
LINDA K DILLON |
| K032162 |
08/08/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K032000 |
08/13/2003 |
COULTER LH 500 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K032287 |
08/18/2003 |
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
KIM WALKER |
| K032035 |
08/07/2003 |
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI |
BECKMAN COULTER, INC. |
KIM WALKER |
| K032131 |
08/18/2003 |
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K031943 |
08/06/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K031984 |
08/27/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K031851 |
08/01/2003 |
DENTISEPTIC HPC |
BETHEL, INC |
ERIC WADE |
| K032526 |
08/29/2003 |
BINDER CO2 INCUBATOR SERIE CB |
BINDER GMBH |
PAUL DISTLER |
| K023913 |
08/25/2003 |
NEUROTECH BAXOLVE TYPE 294 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
| K032017 |
08/08/2003 |
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 |
BIO-RAD |
MARIA ZEBALLOS |
| K031043 |
08/27/2003 |
D-10 HEMOGLOBIN A1C |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
| K031427 |
08/19/2003 |
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K032314 |
08/22/2003 |
VITEK 2 GRAM POSITIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K031865 |
08/13/2003 |
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K031693 |
08/06/2003 |
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA |
BIOMET, INC. |
PATRICIA S BERES |
| K030055 |
08/11/2003 |
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K032396 |
08/21/2003 |
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS |
BIOMET, INC. |
GARY BAKER |
| K032453 |
08/28/2003 |
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K030192 |
08/20/2003 |
DUET SYSTEM |
BIOVIEW LTD. |
ORLY MAOR |
| K032207 |
08/20/2003 |
COBRA COOLED SURGICAL PROBE, MODEL M004159670 |
BOSTON SCIENTIFIC CORP. |
APRIL I MALMBORG |
| K032183 |
08/01/2003 |
IQ HYDROPHILIC GUIDE WIRE |
BOSTON SCIENTIFIC CORP. |
ANNE V ROSSI |
| K032360 |
08/27/2003 |
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT |
BOSTON SCIENTIFIC CORP. |
TODD KORNMANN |
| K032050 |
08/08/2003 |
PERIVAC KIT |
BOSTON SCIENTIFIC CORP. |
RONALD C ALLEN |
| K032375 |
08/19/2003 |
VAXCEL PORT, MODELS 45-336 AND 45-338 |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K031049 |
08/01/2003 |
GUGLIELMI DETACHABLE COIL (GDC) |
BOSTON SCIENTIFIC, TARGET |
ROXANE BAXTER |
| K031770 |
08/12/2003 |
CI TKR/UKR |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K032057 |
08/21/2003 |
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K032325 |
08/28/2003 |
JOBST TRAVEL SOCKS |
BSN-JOBST, INC. |
ANGELO PEREIRA |
| K032432 |
08/28/2003 |
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER |
BUSSE HOSPITAL DISPOSABLES, INC. |
JOSEPH M AZARY |
| K030277 |
08/06/2003 |
SOFT-CELL DUAL LUMEN CATHETERS |
C.R. BARD, INC. |
GLENN NORTON |
| K031749 |
08/21/2003 |
BODYGUARD INFUSION SYSTEM |
CAESAREA MEDICAL ELECTRONICS LTD. |
GALI TZURY |
| K032142 |
08/08/2003 |
DATACAPTOR |
CAPSULE TECHNOLOGIE |
DANIEL KAMM |
| K032347 |
08/21/2003 |
BIOMARC TISSUE MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K030357 |
08/20/2003 |
QUANTIX/OR DEVICE |
CARDIOSONIX, LTD. |
AHAVA STEIN |
| K032068 |
08/22/2003 |
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 |
CARDIOVENTION, INC. |
TESSA YAMUT |
| K031735 |
08/21/2003 |
CENTURION SES EPIKERATOME |
CIBA VISION CORPORATION |
PENNY NORTHCUTT |
| K031957 |
08/14/2003 |
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K031921 |
08/25/2003 |
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K031577 |
08/06/2003 |
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K031752 |
08/05/2003 |
COLTOSOL F |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
| K031779 |
08/06/2003 |
CADSTREAM |
CONFIRMA, INC. |
PATRICIA A MILBANK |
| K031323 |
08/01/2003 |
DBT, DYNAMIC BUBBLE TRAP |
CONVERGENZA AG |
CHRISTIE DEWITT |
| K030441 |
08/29/2003 |
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT |
COOK OB/GYN |
BRENDA DAVIS |
| K030742 |
08/29/2003 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYO VASCULAR SYSTEMS INC. |
KIM TOMPKINS |
| K030281 |
08/20/2003 |
CRYOTRON 2 CRYOTHERAPY DEVICE |
CRYONIC MEDICAL NORTH AMERICA |
SANDRA WILLIAMSON |
| K031651 |
08/13/2003 |
MODIFICATION TO CERASORB ORTHO |
CURASAN AG |
ROLF KAUFMANN |
| K032014 |
08/07/2003 |
N LATEX IGM |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K031636 |
08/11/2003 |
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX |
DATASCOPE CORP. |
SUSAN MANDY |
| K024250 |
08/25/2003 |
MATCH PRESS PRESSABLE CERAMIC |
DAVIS SCHOTTLANDER & DAVIS, LTD. |
CLYDE E INGERSOLL |
| K031706 |
08/06/2003 |
CARDIOQ, MODEL 9051-7005 |
DELTEX MEDICAL |
LAWERENCE BROOKFIELD |
| K030977 |
08/25/2003 |
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE |
DENTAURUM |
JAN W.A. DOORSCHODT |
| K030980 |
08/25/2003 |
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE |
DENTAURUM |
JAN W.A. DOORSCHODT |
| K012681 |
08/22/2003 |
ANKYLOS |
DENTSPLY CERAMCO |
THOMAS B CAMERON |
| K031461 |
08/05/2003 |
CARRIER TIPS |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K032097 |
08/08/2003 |
DEPUY ACE VERSANAIL TIBIAL NAIL |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI ROGERS |
| K030908 |
08/11/2003 |
DEROYAL SURGICAL DRAPES BACKTABLE COVER |
DEROYAL |
AUDREY DANIELS |
| K032283 |
08/20/2003 |
DESIGNS FOR VISION FIBEROPTIC LIGHT |
DESIGNS FOR VISION, INC. |
MARY MCNAMARA-CULLINANE |
| K030730 |
08/18/2003 |
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT |
DIAGNOSTICS BIOCHEM CANADA, INC. |
G. R DUMONT |
| K031401 |
08/06/2003 |
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
| K031816 |
08/14/2003 |
DVNET MDV-PACS |
DVNET INTERNATIONAL TECHNOLOGY CO.,LTD. |
JEN KE-MIN |
| K031354 |
08/06/2003 |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K032390 |
08/29/2003 |
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
EBI, L.P. |
BARRY SANDS |
| K032500 |
08/25/2003 |
MODIFICARION TO WACKERS-LIU CQ SOFTWARE |
ECLIPSE SYSTEMS, INC. |
ROSINA ROBINSON |
| K032250 |
08/26/2003 |
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 |
EDWARDS LIFESCIENCES, LLC. |
SUSAN REYNOLDS |
| K032026 |
08/27/2003 |
LCD MONITOR, RADIFORCE G11, G31, G51 |
EIZO NANAO CORPORATION |
KAY HAMAGUCHI |
| K032466 |
08/22/2003 |
SPIDERVIEW |
ELA MEDICAL, INC. |
SUSAN OLIVE |
| K032333 |
08/12/2003 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
EBEN GORDON |
| K032225 |
08/20/2003 |
EP-WORKMATE WITH RPM SYSTEM |
EP MEDSYSTEMS |
JAMES E KUHN |
| K023140 |
08/15/2003 |
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER B LAKE |
| K031778 |
08/07/2003 |
PRACTICEBUILDER 1-2-3 |
ERAD IMAGEMEDICAL CORP. |
GARY J ALLSEBROOK |
| K032121 |
08/13/2003 |
MODIFICATION TO E-SCAN XQ |
ESAOTE S.P.A. |
COLLEEN J DENSMORE |
| K032272 |
08/26/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
| K032236 |
08/26/2003 |
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
| K032339 |
08/08/2003 |
CARDIOVATIONS PORTABLE VIDEO SYSTEM |
ETHICON, INC. |
PETER CECCHINI |
| K032206 |
08/08/2003 |
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION |
EV3 INC |
GLEN D SMYTHE |
| K030374 |
08/25/2003 |
SONIK LDI 20 AIR |
EVIT LABS, INC. |
S. DAVID PIPER |
| K023400 |
08/22/2003 |
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT |
FCI OPHTHALMICS, INC. |
HILLARD W WELCH |
| K031830 |
08/05/2003 |
SAFEPRO PLUS SAFETY SYRINGE |
FORMOSA MEDICAL DEVICES, INC. |
JOSEPH J CHANG |
| K031674 |
08/14/2003 |
MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
| K032158 |
08/14/2003 |
XIVE DENTAL IMPLANT SYSTEM MULTIPLE |
FRIADENT GMBH |
CAROL PATTERSON |
| K032284 |
08/14/2003 |
XIVE TG DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
| K030639 |
08/12/2003 |
XIVE 3.0 DENTAL IMPLANT SYSTEM |
FRIANDENT GMBH |
CAROL PATTERSON |
| K031637 |
08/22/2003 |
INNOVA 3100 |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K031561 |
08/01/2003 |
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DAVID WAHLIG |
| K032370 |
08/13/2003 |
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
| K032252 |
08/21/2003 |
MODEL 120 SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K032369 |
08/15/2003 |
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K032346 |
08/05/2003 |
UNITY NETWORK IS PATIENT VIEWER |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K030574 |
08/21/2003 |
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER |
GLUSTITCH, INC. |
DON BLACKLOCK |
| K030795 |
08/05/2003 |
LIFESYNE SYSTEMS |
GMP/COMPANIES, INC. |
RALPH JUGO |
| K031678 |
08/26/2003 |
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
BRUCE CERWIN |
| K032203 |
08/25/2003 |
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 |
HEMOCUE, INC. |
R. J SLOMOFF |
| K020424 |
08/29/2003 |
V SET |
HENNIG ENTERPRISES EUROPE S.R.L. |
GEORGE O'NEIL |
| K031387 |
08/01/2003 |
ISOLETTE INFANT INCUBATOR, MODEL C2000E |
HILL-ROM MANUFACTURING, INC. |
MONICA FERRANTE |
| K032503 |
08/22/2003 |
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K031432 |
08/07/2003 |
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II |
HK SURGICAL, INC. |
SALLY M BOWDON |
| K023279 |
08/04/2003 |
GLUCOLEADER VALUE |
HMD BIOMEDICAL, INC. |
JEFFREY FLEISHMAN |
| K031435 |
08/04/2003 |
BONESOURCE BVF |
HOWMEDICA OSTEONICS |
DEBRA BING |
| K031702 |
08/08/2003 |
REFLEX ANTERIOR CERVICAL PLATE SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K031730 |
08/29/2003 |
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K032244 |
08/08/2003 |
GAMMA 3 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K032264 |
08/08/2003 |
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K031744 |
08/08/2003 |
OMNIFIT HFX HIP STEM SERIES |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K030369 |
08/08/2003 |
OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K032579 |
08/29/2003 |
S2 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K031657 |
08/22/2003 |
STRYKER SPINE OASYS BONE SCREW |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K012715 |
08/01/2003 |
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II |
HYGIA HEALTH SERVICES, INC. |
TRACY COMAS |
| K032254 |
08/29/2003 |
IBL C1Q-CIC CIA TEST |
IBL GMBH |
Gary Lehnus |
| K031885 |
08/21/2003 |
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K030596 |
08/08/2003 |
IMMUNICON CELLSAVE PRESERVATIVE TUBE |
IMMUNICON CORP. |
PETER SCOTT |
| K032282 |
08/21/2003 |
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM |
IMPLEX CORP. |
MARCI HALEVI |
| K031462 |
08/06/2003 |
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS |
IMPLEX CORP. |
MARCI HALEVI |
| K031106 |
08/12/2003 |
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX |
IMTEC CORP. |
J. BRAD VANCE |
| K031712 |
08/28/2003 |
INION OTPS BIODEGRADABLE PIN |
INION LTD. |
HANNA MARTTILA |
| K030316 |
08/07/2003 |
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) |
INOVISE MEDICAL, INC. |
KENDRA RATHKEY |
| K031639 |
08/22/2003 |
INTERMED ZOOM COLPOSCOPE |
INTERMED GROUP, INC. |
GEORGE GARAMY, JR. |
| K032095 |
08/08/2003 |
INTERPORE CROSS CEMENT RESTRICTOR |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K031692 |
08/22/2003 |
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K031665 |
08/27/2003 |
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS |
IRIDEX CORP. |
JOHN JOSSY |
| K031204 |
08/21/2003 |
DENTAPORT ZX |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K030529 |
08/08/2003 |
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE |
JDA (TIANJIN) PLASTIC RUBBER CO., LTD. |
CHEN YUHONG |
| K030479 |
08/18/2003 |
JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET |
JMS NORTH AMERICA CORP. |
SWEE CHEAU |
| K031544 |
08/07/2003 |
HEATER COOLER UNIT, MODEL HCU 30 |
JOSTRA AB |
LE ANN LATHAM |
| K030219 |
08/05/2003 |
DIGITAL TEMPERATURE MONITOR; MODEL KY-01 |
KANG YING MEDICAL APPLIANCES INC. |
CHING-CHU CHEN |
| K030237 |
08/29/2003 |
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
| K030693 |
08/27/2003 |
KENTEX DISPOSABLE VAGINAL SPECULUM |
KENTRON HEALTH CARE, INC. |
DR. SADARANGANI |
| K032041 |
08/27/2003 |
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) |
LEMAITRE VASCULAR, INC. |
CARLOS CHAPARRO |
| K031282 |
08/05/2003 |
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 |
LEMAITRE VASCULAR, INC. |
BRIAN K KEOGH |
| K031472 |
08/05/2003 |
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS |
LIFESCAN, INC. |
FRANK PERALTA |
| K031994 |
08/21/2003 |
LINVATEC 300W XENON LIGHT SOURCE |
LINVATEC CORP. |
LAURA D KREJCI |
| K032298 |
08/26/2003 |
MODIFICATION TO OUTBACK CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K032191 |
08/20/2003 |
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM |
LUXSANO AB |
Connie Hoy |
| K030440 |
08/26/2003 |
OASYS-ORAL AIRWAY SYSTEM |
MARK ABRAMSON, D.D.S., INC |
MARK ABRAMSON |
| K031866 |
08/14/2003 |
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC |
MED-TEC,INC. |
DONALD F RIIBE |
| K032335 |
08/19/2003 |
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K031442 |
08/13/2003 |
PBN GUIDEWIRES |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K030490 |
08/20/2003 |
ISM1+, IMS2+, AND UTM+ |
MEDICULT A/S |
RONALD G LEONARDI |
| K032329 |
08/06/2003 |
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
A. ROBERT DEPALMA |
| K031483 |
08/01/2003 |
MEDRAD MANUAL SYRINGE LOADER |
MEDRAD, INC. |
ANDREW P ZELTWANGER |
| K023735 |
08/07/2003 |
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 |
MEDSYS, S.A. |
JEFF MORGAN |
| K022587 |
08/22/2003 |
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K031917 |
08/19/2003 |
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S |
MEDTRONIC MINIMED |
MIRIELLE MENGOTTO |
| K032005 |
08/22/2003 |
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 |
MEDTRONIC MINIMED |
MIRIELLE MENGOTTO |
| K031700 |
08/29/2003 |
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K032265 |
08/11/2003 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K031814 |
08/14/2003 |
STATCO2METER, MODEL 10-55372 |
MERCURY MEDICAL |
WAYNE GLOVER |
| K031532 |
08/01/2003 |
SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR |
METRO OPTICS OF AUSTIN, INC. |
DEANNA WERBER |
| K031600 |
08/13/2003 |
CONDUCTION CATHETER |
MICOR, INC. |
SUSAN FORGRAVE |
| K030586 |
08/27/2003 |
MICROPEAK |
MICRO DIRECT, INC. |
DAVID R STASZAK |
| K031992 |
08/07/2003 |
ECHELON MICRO CATHETER, MODEL 105-5091 |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
| K031852 |
08/20/2003 |
SAPPHIRE DETACHABLE FIBER COILS |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| K023617 |
08/27/2003 |
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY |
MICROGENICS CORP. |
LAKSHMI ANNE |
| K031958 |
08/15/2003 |
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K031578 |
08/01/2003 |
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR |
MICRUS CORP. |
MARGARET WEBBER |
| K030525 |
08/27/2003 |
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES |
MID-ATLANTIC DIAGNOSTICS, INC. |
SUSAN J BUSH |
| K030957 |
08/20/2003 |
PERFECT CAPSULE |
MILVELLA PTY. LTD. |
JUDY F GORDON |
| K032078 |
08/25/2003 |
MITEK MICRO QUICKANCHOR |
MITEK WORLDWIDE |
SERGIO J GADALETA |
| K030860 |
08/22/2003 |
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 |
MONOBIND |
JAY SINGH |
| K032090 |
08/21/2003 |
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K032429 |
08/21/2003 |
QSC-127 SHOULDER ARRAY COIL SET |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K030119 |
08/06/2003 |
NANMA ADJUSTABLE CONSTRICTION RING |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
| K032301 |
08/21/2003 |
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 |
NEOGEN TECHNOLOGIES, INC |
LYDIA B BIGGIE |
| K031900 |
08/08/2003 |
HANDMASTER |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
JONATHAN KAHAN |
| K031954 |
08/21/2003 |
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K031582 |
08/01/2003 |
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 |
NIHON SEIMITSU SOKKI CO., LTD. |
DANIEL KAMM |
| K032256 |
08/29/2003 |
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE |
NO 7 CONTACT LENS LABORATORY LTD. |
MARTIN DALSING |
| K032209 |
08/21/2003 |
NOMOS CORVUS 5.0M |
NOMOS CORP. |
FRANCIS X DOBSCHA |
| K031907 |
08/21/2003 |
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K030066 |
08/29/2003 |
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 |
NUCLEAR ASSOCIATES |
CHRISTINE G CASTLEBERRY |
| K031349 |
08/07/2003 |
OTP 1.2 |
NUCLETRON CORP. |
LISA DIMMICK |
| K031158 |
08/07/2003 |
SWIFT 2.0, MODEL 132.001 |
NUCLETRON CORP. |
LISA DIMMICK |
| K032372 |
08/15/2003 |
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K032297 |
08/26/2003 |
DISPOSABLE N-PE MICKROKERATOME BLADES |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
| K032285 |
08/21/2003 |
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K032401 |
08/14/2003 |
ORTHOVIEW |
OMSBAR LTD |
ANTHONY THORNE |
| K031924 |
08/07/2003 |
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 |
ORTHO-CLINICAL DIAGNOSTICS |
NEIL GREENBERG |
| K032296 |
08/13/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
SUSAN WERNER |
| K023884 |
08/20/2003 |
MODIFICATION ORIA SPINAL SYSTEM |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K032409 |
08/29/2003 |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
ORTHOVITA, INC. |
ANDREINA IDE |
| K031155 |
08/22/2003 |
OSTEOMED SUBTALAR IMPLANT SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
| K020419 |
08/29/2003 |
V SET |
P.T. GREENLEAF |
GEORGE O'NEIL |
| K032063 |
08/18/2003 |
PEM 2400 PET SCANNER |
PEM TECHNOLOGIES |
IRVING WEINBERG |
| K031789 |
08/08/2003 |
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K031768 |
08/01/2003 |
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K031625 |
08/01/2003 |
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K031187 |
08/27/2003 |
HEARTSTART MRX, MODEL M3535A |
PHILIPS MEDICAL SYSTEMS |
PETER OHANIAN |
| K031836 |
08/14/2003 |
PHILIPS FRESCO RELEASE 1 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
| K031451 |
08/01/2003 |
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 |
PHOTO MEDEX, INC. |
BOB ROSE |
| K024313 |
08/29/2003 |
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
PISHARODI SURGICALS, INC. |
J.D. WEBB |
| K032202 |
08/01/2003 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I |
PLANAR SYSTEMS, INC. |
SUSAN HAMANN |
| K032215 |
08/08/2003 |
VKS/TC-PLUS REVISION KNEE |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K031539 |
08/06/2003 |
HEMOGLOBIN A1C REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K030381 |
08/27/2003 |
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA |
PORTEX LTD. |
STEVE OGILVIE |
| K031630 |
08/07/2003 |
BIFURCATED ALLERGY SKIN TESTING NEEDLE |
PRECISION MEDICAL PRODUCTS, INC. |
RONALD D WOLFE |
| K032018 |
08/25/2003 |
EASY PULSE II OXYGEN CONSERVER |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K032146 |
08/12/2003 |
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES |
PRECISION VASCULAR SYSTEMS, INC. |
RICK GAYKOWSKI |
| K031975 |
08/29/2003 |
IMSURE |
PRODIGM, INC. |
SUZANNE WILD |
| K032010 |
08/19/2003 |
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K032011 |
08/19/2003 |
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K023014 |
08/14/2003 |
VIANOX DELIVERY SYSTEM, MODEL I |
PULMONOX MEDICAL, INC. |
PAULA TOMAT |
| K031877 |
08/01/2003 |
EMBRACE WET-BOND RESTORATIVE MATERIAL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K031915 |
08/05/2003 |
PULPDENT ETCH-RITE ROYALE |
PULPDENT CORPORATION |
KENNETH J BERK |
| K031157 |
08/15/2003 |
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 |
| K030487 |
08/01/2003 |
R 72 |
RALCO S.R.L. |
DANIEL KAMM |
| K031562 |
08/11/2003 |
RAMSOFT PACS, MODEL 3.0 |
RAMSOFT, INC. |
LUCIAN POPESCU |
| K031608 |
08/08/2003 |
RANDOX LIQUID PROTEIN CALIBRATOR |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K032276 |
08/27/2003 |
CLICK HOLTER |
REMCO ITALIA S.P.A. |
LUIGI BUCCHI |
| K031047 |
08/19/2003 |
MIRAGE VISTA MASK |
RESMED LTD. |
ROGER KOTTER |
| K030843 |
08/15/2003 |
VPAP III |
RESMED LTD. |
ROGER KOTTER |
| K024283 |
08/01/2003 |
CARDIODIRECT, MODELS 12M, 12I, 12S |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
| K031990 |
08/20/2003 |
ELECSYS PRECICONTROL TROPONIN T |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K031717 |
08/05/2003 |
ELECSYS SHBG IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K031698 |
08/20/2003 |
ELECYS SHBG CALCHECK |
ROCHE DIAGNOSTICS CORP. |
THERESA A AMBROSE |
| K031775 |
08/05/2003 |
PRECISET DAT PLUS I CALIBRATORS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K031856 |
08/06/2003 |
PRECISET TDM I AND PRECISET TDM II CALIBRATORS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K032377 |
08/21/2003 |
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032049 |
08/22/2003 |
ROCHE ONLINE TDM VALPROIC ACID |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K032336 |
08/05/2003 |
TINA-QUANT CRP (LATEX) |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032015 |
08/08/2003 |
EMBRYON ULTRASOUND NEEDLE GUIDE |
ROCKET MEDICAL PLC |
TRACY CHARLTON |
| K032080 |
08/14/2003 |
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
| K031420 |
08/20/2003 |
S & C -BRACKET ADHESIVES |
S & C POLYMER GMBH |
CHRISTIAN BOETTTCHER |
| K031574 |
08/04/2003 |
SQUEEZE-EASE MAMMOGRAPHY CUSHION |
S & S X-RAY PRODUCTS, INC. |
SUSAN D GOLDSTEIN-FALK |
| K031697 |
08/29/2003 |
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 |
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. |
PHILIP JOHNSON |
| K030302 |
08/08/2003 |
HBS HEADLESS BONE SCREW |
SCHOENING & ASSOC., INC. |
Kevin Walls |
| K032077 |
08/19/2003 |
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) |
SEAL POLYMER INDUSTRIES BHD. |
CHUN CHOOI FONG |
| K030379 |
08/29/2003 |
APLAB, MODEL 801D0030 |
SECTOR MEDICAL CORP. |
BRADLEY JEFFRIES |
| K031883 |
08/25/2003 |
LYRA NASAL MASK |
SENSORMEDICS CORP. |
PAUL L KITTINGER |
| K032293 |
08/28/2003 |
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN |
SGMP CO., LTD. |
JANNA TUCKER |
| K032294 |
08/28/2003 |
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING |
SGMP CO., LTD. |
JANNA TUCKER |
| K031771 |
08/21/2003 |
SHIMADZU COLLIMATOR R-30H |
SHIMADZU CORP. |
TAKESHI OZAKI |
| K031433 |
08/19/2003 |
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K031584 |
08/19/2003 |
SIROTORQUE L |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K031707 |
08/01/2003 |
SK MED M201 PLUS MIXER |
SK MED |
DIPAK GHOSH |
| K032224 |
08/08/2003 |
BIORCI SCREW |
SMITH & NEPHEW, INC. |
MARION W GORDON |
| K032295 |
08/21/2003 |
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K032197 |
08/08/2003 |
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 |
SMITH & NEPHEW, INC. |
JASON BILOBRAM |
| K031586 |
08/07/2003 |
CORRESTORE PATCH SYSTEM |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K032341 |
08/25/2003 |
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 |
SOTA PRECISION OPTICS, INC. |
JAY MANSOUR |
| K032152 |
08/06/2003 |
BENCO ADMIX |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K031672 |
08/07/2003 |
SPINAL CONCEPTS, INC. INFIX SYSTEM |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K031318 |
08/22/2003 |
TRAXIS CEMENT RESTRICTOR |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K032106 |
08/25/2003 |
STARBOND DENTAL BONDING ALLOYS |
STAR REFINING PRECIOUS METALS SOUTH AFRICA |
YOLANDA SMITH |
| K032246 |
08/13/2003 |
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM |
STARPLEX SCIENTIFIC, INC. |
MEHDI KARAMCHI |
| K032452 |
08/21/2003 |
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K024293 |
08/11/2003 |
BOWIE-DICK MINI PAK, MODEL BD 115 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K032213 |
08/29/2003 |
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP |
STOCKERT INSTRUMENTE GMBH |
CYNTHIA J.M. NOLTE |
| K032498 |
08/27/2003 |
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) |
STRAUMANN USA |
LINDA JALBERT |
| K031068 |
08/12/2003 |
STRYKER VISUM SURGICAL LIGHTING SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K032117 |
08/08/2003 |
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
| K023856 |
08/25/2003 |
VISUALINE METHADONE DIPSTRIPTEST |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K031988 |
08/01/2003 |
AURORA DS |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K031993 |
08/01/2003 |
AURORA SR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K031489 |
08/19/2003 |
PITANGA |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K032172 |
08/14/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K032190 |
08/14/2003 |
DISPOSABLE POWDERED VINYL EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031677 |
08/21/2003 |
SYNTHES (USA) CALVICLE HOOK PLATE |
SYNTHES (USA) |
BONNIE J SMITH |
| K031428 |
08/08/2003 |
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE |
SYNTHES (USA) |
BONNIE J SMITH |
| K031654 |
08/08/2003 |
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) |
SYNTHES (USA) |
BONNIE SMITH |
| K021161 |
08/27/2003 |
TSO3 OZONE CHEMICAL INDICATOR |
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC |
CHARLES O HANCOCK |
| K020875 |
08/26/2003 |
TSO3 OZONE STERILIZER, MODEL 125L |
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC |
CHARLES O HANCOCK |
| K032128 |
08/01/2003 |
TERUMO AL8X ARTERIAL FILTER WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K032088 |
08/01/2003 |
MODIFICATION TO THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K032132 |
08/20/2003 |
TISSUELINK FLOATING BALL MODEL 23-201-1 |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K032281 |
08/06/2003 |
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K032490 |
08/21/2003 |
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K032382 |
08/29/2003 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K032306 |
08/22/2003 |
VERSATREK |
TREK DIAGNOSTIC SYSTEMS, INC. |
NADINE M SULLIVAN |
| K032474 |
08/25/2003 |
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K032415 |
08/25/2003 |
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K023902 |
08/20/2003 |
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE |
USGI MEDICAL, INC. |
JUDY F GORDON |
| K031641 |
08/01/2003 |
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM |
VASCULAR ARCHITECTS, INC. |
PHYLLIS ELSON |
| K032204 |
08/20/2003 |
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
DEBORAH JENSEN |
| K023548 |
08/04/2003 |
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 |
VELOCIMED |
JOHN CARLINE |
| K021981 |
08/13/2003 |
IVENT 201 PORTABLE VENTILATOR |
VERSAMED LTD. |
KEN RAICHMAN |
| K031713 |
08/12/2003 |
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS |
VIASYS HEALTHCARE, INC. |
Gary Syring |
| K030517 |
08/01/2003 |
BALL RECORDING ELECTRODE/STIMULATION PROBE |
VIASYS HEALTHCARE, INC. |
Gary Syring |
| K032483 |
08/22/2003 |
VIATRONIX V3D EXPLORER, REVISION 1.2 |
VIATRONIX, INC. |
MICHAEL MEISSNER |
| K031786 |
08/05/2003 |
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K024359 |
08/08/2003 |
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 |
VISTA SCIENTIFIC, LLC |
JONATHAN MODINE |
| K031748 |
08/27/2003 |
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES |
VITALCARE GROUP, INC. |
MICHAEL MCAVENIA |
| K032047 |
08/06/2003 |
TRI-LOOP MICROWAVE ABLATION PROBE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K031551 |
08/20/2003 |
NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) |
VYTERIS, INC. |
GEORGE M BASKINGER |
| K032073 |
08/13/2003 |
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K032168 |
08/15/2003 |
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K031616 |
08/13/2003 |
IUR FLUID MANAGEMENT SYSTEM |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K022721 |
08/26/2003 |
UROPOWER |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K032228 |
08/11/2003 |
LORENZ 2.4 SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K031740 |
08/26/2003 |
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES |
WELCH ALLYN PROTOCOL, INC. |
JAMES W SANDBERG |
| K031548 |
08/11/2003 |
LED HEADLIGHT |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
| K031549 |
08/11/2003 |
SOLID STATE LAMP [LED] HEADLIGHT |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
| K031634 |
08/29/2003 |
OMNIPRO I'MRT |
WELLHOFER DOSIMETRIE |
THOMAS MATZEN |
| K030384 |
08/12/2003 |
EVOLVE CERAMIC RADIAL HEAD IMPLANT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
| K032464 |
08/22/2003 |
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K032367 |
08/12/2003 |
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
