| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K032099 |
07/08/2003 |
SWISS MASTER LIGHT |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
CYNTHIA J M. NOLTE |
| K032070 |
07/03/2003 |
ELCACAM |
A-DEC, INC. |
TOM LOUISELL |
| K032122 |
07/09/2003 |
AUDIT MICROCONTROLS MICROFD BNP CONTROL |
AALTO SCIENTIFIC LTD. |
ALAN J VEKICH |
| K032051 |
07/02/2003 |
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P |
ACCESS BATTERY, INC. |
ALEXANDER B HENDERSON |
| K032159 |
07/15/2003 |
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K032345 |
07/30/2003 |
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
| K032220 |
07/21/2003 |
ADEPT 1064/532 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032218 |
07/21/2003 |
ADEPT 1064/532/755 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032221 |
07/21/2003 |
ADEPT 1064/755 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032030 |
07/01/2003 |
BLINK CL LUBRICANT EYE DROPS |
ADVANCED MEDICAL OPTICS, INC. |
PAUL J NOWACKI |
| K032034 |
07/01/2003 |
ANS AXXESS PERCUTANEOUS LEAD |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K032198 |
07/18/2003 |
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP |
AESCULAP, INC. |
MATTHEW M HULL |
| K032059 |
07/02/2003 |
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM |
AESCULAP, INC. |
GEORG KELLER |
| K032108 |
07/08/2003 |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) |
AESCULAP, INC. |
JOYCE KILROY |
| K032248 |
07/22/2003 |
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 |
AKTINA MEDICAL PHYSICS CORP. |
TONY SPACCAROTELLA |
| K032210 |
07/21/2003 |
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM |
ALARA, INC. |
DIANE M KING |
| K032233 |
07/21/2003 |
MEDLEY PCA MODULE, MODEL 8120 |
ALARIS MEDICAL SYSTEMS, INC. |
STACEY L LEWIS |
| K032147 |
07/14/2003 |
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES |
ALARIS MEDICAL SYSTEMS, INC. |
STACY L LEWIS |
| K032058 |
07/02/2003 |
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K032278 |
07/24/2003 |
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE |
AMBU, INC. |
SANJAY PARIKH |
| K032069 |
07/03/2003 |
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K032257 |
07/22/2003 |
MODEL IR 1200 INSULIN PUMP |
ANIMAS CORP. |
MICHAEL J ANDREWS |
| K032217 |
07/21/2003 |
14G CORMARK BIOPSY SITE IDENTIFIER |
ARTEMIS MEDICAL, INC. |
LINDA GUTHRIE |
| K032187 |
07/17/2003 |
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM |
ARTHREX, INC. |
SALLY FOUST |
| K032098 |
07/08/2003 |
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B |
ARTHREX, INC. |
ANN WATERHOUSE |
| K032245 |
07/22/2003 |
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 |
ARTHREX, INC. |
ANN WATERHOUSE |
| K032072 |
07/03/2003 |
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE |
ARTHROTEK, INC. |
TRACY J BICKEL |
| K032160 |
07/15/2003 |
ARTELON SURGICAL SUTURE |
ARTIMPLANT AB |
RUSS PAGANO |
| K032082 |
07/07/2003 |
AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
JAMES R VEALE |
| K032144 |
07/14/2003 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
AMY SMITH |
| K032261 |
07/23/2003 |
MODIFICATION TO TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH), TRELLIS RESERVE INFUSION |
BACCHUS VASCULAR, INC. |
GREGORY J MATHISON |
| K033006 |
07/25/2003 |
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
| K032153 |
07/14/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML |
BD DIAGNOSTIC SYSTEMS |
KATHRYN BABKA POWERS |
| K032259 |
07/22/2003 |
PASCO MIC AND MIC/ID PANELS |
BD DIAGNOSTIC SYSTEMS |
LINDA K DILLON |
| K032162 |
07/15/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K032342 |
07/29/2003 |
COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K032287 |
07/24/2003 |
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
KIM WALKER |
| K032035 |
07/01/2003 |
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI |
BECKMAN COULTER, INC. |
KIM WALKER |
| K032131 |
07/11/2003 |
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 |
| K032299 |
07/25/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML |
BECTON, DICKINSON & CO. |
BRADFORD SPRING |
| K032275 |
07/23/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K032136 |
07/11/2003 |
WIROBOND C |
BEGO U.S.A. |
WILLIAM OREMUS |
| K032166 |
07/16/2003 |
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 |
BINAX, INC. |
PAMELA ANGELL |
| K032104 |
07/08/2003 |
AMNIOLENS |
BIO-TISSUE, INC. |
DAVID J BLOCH |
| K032351 |
07/30/2003 |
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON D GREER |
| K032268 |
07/23/2003 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K032314 |
07/28/2003 |
VITEK 2 GRAM POSITIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032286 |
07/24/2003 |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
| K032216 |
07/21/2003 |
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM |
BIOPTRON AG |
Kevin Walls |
| K032235 |
07/21/2003 |
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K032292 |
07/24/2003 |
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX |
BIOTEQUE CORP. |
JENNIFER REICH |
| K032207 |
07/18/2003 |
COBRA COOLED SURGICAL PROBE, MODEL M004159670 |
BOSTON SCIENTIFIC CORP. |
APRIL I MALMBORG |
| K032183 |
07/17/2003 |
IQ HYDROPHILIC GUIDE WIRE |
BOSTON SCIENTIFIC CORP. |
ANNE V ROSSI |
| K032360 |
07/31/2003 |
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT |
BOSTON SCIENTIFIC CORP. |
TODD KORNMANN |
| K032050 |
07/02/2003 |
PERIVAC KIT |
BOSTON SCIENTIFIC CORP. |
RONALD C ALLEN |
| K032214 |
07/21/2003 |
MEDONIC CA620/530 HEMATOLOGY ANALYZER |
BOULE MEDICAL AB |
ANDREW SWANSON |
| K032057 |
07/02/2003 |
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K032133 |
07/11/2003 |
BRODA MODEL 587 MANUAL WHEELCHAIR |
BRODA ENT., INC. |
PHILLIP MCTAGGART |
| K032325 |
07/28/2003 |
JOBST TRAVEL SOCKS |
BSN-JOBST, INC. |
ANGELO PEREIRA |
| K032029 |
07/01/2003 |
BTG SMARTEST GLUCOSE TEST SYSTEM |
BT MEDICAL |
DEBBIE CHENG |
| K032044 |
07/02/2003 |
X-PROT DUO PORT |
C.R. BARD, INC. |
JOHN C KNORPP |
| K032142 |
07/14/2003 |
DATACAPTOR |
CAPSULE TECHNOLOGIE |
DANIEL KAMM |
| K032347 |
07/30/2003 |
BIOMARC TISSUE MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K032068 |
07/03/2003 |
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 |
CARDIOVENTION, INC. |
TESSA YAMUT |
| K032116 |
07/09/2003 |
TULIP COLORSWITCH |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K032348 |
07/30/2003 |
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP |
CENTERPULSE ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K032076 |
07/07/2003 |
SENOVA(R) BLOOD GLUCOSE MONITOR |
CHDIAGNOSTICS LLC |
RICHARD N PHILLIPS |
| K032027 |
07/01/2003 |
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) |
CHOLESTECH CORP. |
THOMAS E WORTHY |
| K032113 |
07/09/2003 |
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) |
CHROMA VISION MEDICAL SYSTEMS INC. |
DAVID DAVIS |
| K032074 |
07/07/2003 |
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K032100 |
07/08/2003 |
I-BEAM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K032223 |
07/21/2003 |
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
| K032274 |
07/23/2003 |
COOK FIVE LUMEN CENTRAL VENOUS CATHETER |
COOK, INC. |
JENNIFER J BOSLEY |
| K032137 |
07/11/2003 |
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K032139 |
07/11/2003 |
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 |
CORGENIX, INC. |
NANCI DEXTER |
| K032186 |
07/17/2003 |
AUTOALIGN |
CORTECHS LABS, INC. |
ALLAN GREEN |
| K032169 |
07/16/2003 |
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) |
CYBERORTHOLOGY, INC. |
ARTHUR WARD |
| K032237 |
07/21/2003 |
N/T PROTEIN CONTROL |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K032338 |
07/29/2003 |
TRIO MONITOR MODEL 0998-00-0600 |
DATASCOPE CORP. |
SUSAN E MANDY |
| K032195 |
07/18/2003 |
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT |
DENTAURUM |
JAN A DOORSCHODT |
| K032355 |
07/30/2003 |
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW |
DENTSPLY GENDEX |
JOHN R MILLER |
| K032320 |
07/28/2003 |
APPOLLO 3 ALLOY |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K032321 |
07/28/2003 |
CERA F ALLOY |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K032319 |
07/28/2003 |
CERA R PLUS ALLOY |
DENTSPLY INTERNATIONAL |
P. JFFERY LEHN |
| K032318 |
07/28/2003 |
MINERVA 58 ALLOY |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K032361 |
07/31/2003 |
ENDOPURE ROOT CANAL CLEANSER |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K032316 |
07/28/2003 |
ORION E ALLOY |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K032317 |
07/28/2003 |
ORION GX ALLOY |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K032097 |
07/08/2003 |
DEPUY ACE VERSANAIL TIBIAL NAIL |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI ROGERS |
| K032151 |
07/14/2003 |
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS |
DEPUY, INC. |
CHERYL HASTINGS |
| K032283 |
07/24/2003 |
DESIGNS FOR VISION FIBEROPTIC LIGHT |
DESIGNS FOR VISION, INC. |
MARY MCNAMARA-CULLINANE |
| K032040 |
07/01/2003 |
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K032171 |
07/16/2003 |
ACCUSOFT |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K032358 |
07/30/2003 |
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONANTHAN S KAHN |
| K032135 |
07/11/2003 |
SITE-RITE IV ULTRASOUND SYSTEM |
DYMAX CORP. |
CHARLES MORREALE |
| K032250 |
07/22/2003 |
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 |
EDWARDS LIFESCIENCES, LLC. |
SUSAN REYNOLDS |
| K032091 |
07/07/2003 |
SMART KLAMP VARIOUS BY SIZE |
EMERGO GROUP, INC. |
RENE' VAN DE ZANDE |
| K032105 |
07/08/2003 |
ENDOHELIX ENDARTERECTOMY DEVICE |
ENDARX, INC. |
SCOTT ADAMS |
| K032333 |
07/29/2003 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
EBEN GORDON |
| K032225 |
07/21/2003 |
EP-WORKMATE WITH RPM SYSTEM |
EP MEDSYSTEMS |
JAMES E KUHN |
| K032199 |
07/18/2003 |
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT |
ESA, INC. |
HAROLD ASP |
| K032121 |
07/09/2003 |
MODIFICATION TO E-SCAN XQ |
ESAOTE S.P.A. |
COLLEEN J DENSMORE |
| K032272 |
07/23/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
| K032236 |
07/21/2003 |
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
| K032307 |
07/25/2003 |
CAP BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
Kristine Canavan |
| K032339 |
07/29/2003 |
CARDIOVATIONS PORTABLE VIDEO SYSTEM |
ETHICON, INC. |
PETER CECCHINI |
| K032206 |
07/18/2003 |
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION |
EV3 INC |
GLEN D SMYTHE |
| K032161 |
07/15/2003 |
PHEM-ALERT |
FEMTEK,LLC. |
JOEL S FADEN |
| K032208 |
07/18/2003 |
MONA LISA ASPIRATION NEEDLE |
FERTILITY TECHNOLOGY RESOURCES, INC. |
CONSTANCE W STURGEON |
| K032173 |
07/16/2003 |
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS |
FIRST QUALITY HYGIENIC, INC. |
ROBERT J STAAB |
| K032158 |
07/15/2003 |
XIVE DENTAL IMPLANT SYSTEM MULTIPLE |
FRIADENT GMBH |
CAROL PATTERSON |
| K032302 |
07/25/2003 |
XIVE TG ABUTMENTS |
FRIADENT GMBH |
CAROL PATTERSON |
| K032284 |
07/24/2003 |
XIVE TG DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
| K032290 |
07/24/2003 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K032289 |
07/24/2003 |
FIT CHECKER II |
GC AMERICA, INC. |
TERRY L JORITZ |
| K032045 |
07/02/2003 |
8 CHANNEL CARDIAC PHASED ARRAY COIL |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K032252 |
07/22/2003 |
MODEL 120 SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K032346 |
07/30/2003 |
UNITY NETWORK IS PATIENT VIEWER |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K032194 |
07/18/2003 |
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS |
GEN-PROBE, INC. |
WAYNE A KVETKOSKY |
| K032182 |
07/17/2003 |
GE LOGIQ 7, MODEL 2354858 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K032337 |
07/29/2003 |
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
| K032127 |
07/10/2003 |
HEMEDEX FIXATION DEVICE |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
| K032203 |
07/18/2003 |
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 |
HEMOCUE, INC. |
R. J SLOMOFF |
| K032232 |
07/21/2003 |
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K032300 |
07/25/2003 |
ACCOLADE-J HIP STEM SERIES |
HOWMEDICA OSTEONICS CORP. |
LORRAINE MONTEMURRO |
| K032163 |
07/15/2003 |
DURACON TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
DENISE DUCHENE |
| K032244 |
07/22/2003 |
GAMMA 3 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K032264 |
07/23/2003 |
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K032315 |
07/28/2003 |
IOP8 INTRA OPERATIVE PROBE |
HUNTLEIGH HEALTHCARE, INC. |
B.J. COLLEYPRIEST |
| K032254 |
07/22/2003 |
IBL C1Q-CIC CIA TEST |
IBL GMBH |
Gary Lehnus |
| K032075 |
07/07/2003 |
CONDUCTIVITY STANDARD SOLUTION-METERCARE |
IBP INSTRUMENTS GMBH |
WERNER PFINGSTMANN |
| K032324 |
07/28/2003 |
ECHOENCODER |
ICARDIOGRAM, INCORPORATED |
JAMES LOEHR |
| K032251 |
07/22/2003 |
IMMUNETECH TOTAL IGE SYSTEM |
IMMUNETECH CORPORATION |
VIVIANNE NOETZEL |
| K032263 |
07/23/2003 |
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
| K032282 |
07/24/2003 |
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM |
IMPLEX CORP. |
MARCI HALEVI |
| K032344 |
07/30/2003 |
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 |
IMPLEX CORP. |
MARCI HALEVI |
| K032350 |
07/30/2003 |
INFRARED SCIENCES BREASTSCAN IR SYSTEM |
INFRARED SCIENCES CORP. |
SUSAN D GOLDSTEIN-FALK |
| K032140 |
07/11/2003 |
5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD M HOLSTEIN |
| K032145 |
07/14/2003 |
AUDICOR UPGRADE SYSTEM |
INOVISE MEDICAL, INC. |
STEVE HESLER |
| K032095 |
07/08/2003 |
INTERPORE CROSS CEMENT RESTRICTOR |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K032322 |
07/28/2003 |
CLEAR-THERM MICRO HME, MODEL 1441 |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
| K032031 |
07/01/2003 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K032267 |
07/23/2003 |
R&D DESIGNATION AP-052-5 |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K032340 |
07/29/2003 |
VISTAKON (GALYFILCON A) SOFT CONTACT LENS |
JOHNSON & JOHNSON VISION CARE, INC. |
JACQUELINE ZIMOVAN |
| K032277 |
07/23/2003 |
JUSTWIN SCOOTER, MODEL JS-401 |
JOY RIDE TECH CO., LTD. |
SHU CHEN CHANG |
| K032081 |
07/07/2003 |
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 |
KAVO AMERICA |
DANIEL KAMM |
| K032087 |
07/07/2003 |
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 |
KEELER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K032310 |
07/28/2003 |
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS |
KINETIC CONCEPTS, INC. |
JUDITH HARBOUR |
| K032134 |
07/11/2003 |
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K032212 |
07/21/2003 |
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A |
KYPHON, INC. |
TIM REEVES |
| K032041 |
07/01/2003 |
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) |
LEMAITRE VASCULAR, INC. |
CARLOS CHAPARRO |
| K032365 |
07/31/2003 |
BENZODIAZEPINE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K032291 |
07/24/2003 |
TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
| K032323 |
07/28/2003 |
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
LONG FIRST (XIAMEN) PLASTICS CO., LTD. |
CHIEN LIN |
| K032298 |
07/25/2003 |
MODIFICATION TO OUTBACK CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K032357 |
07/30/2003 |
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES |
LUMENIS, INC. |
KAREN BAKER |
| K032191 |
07/17/2003 |
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM |
LUXSANO AB |
Connie Hoy |
| K032335 |
07/29/2003 |
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K032055 |
07/02/2003 |
MEDS-4-INF+ |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
C. A. TEKLINSKI |
| K032170 |
07/16/2003 |
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 |
MEDICAL INDUSTRIES AMERICA, INC. |
ANNE B CARLSON |
| K032094 |
07/07/2003 |
PASSMED SPINAL SYSTEM |
MEDICREA |
J.D. WEBB |
| K032362 |
07/31/2003 |
UP-GRADE FOREHEAD THERMOMETER |
MEDISIM LTD. |
DALIA GIVONY |
| K032329 |
07/29/2003 |
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
A. ROBERT DEPALMA |
| K032308 |
07/25/2003 |
BLOOD PRESSURE MONITOR, MODEL M100 |
MEDITEK TECHNOLOGY, INC. |
TONY C.S. CHANG |
| K032065 |
07/03/2003 |
MEDLINE BAND BAGS AND EQUIPMENT COVERS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K032164 |
07/15/2003 |
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 |
MEDTRONIC MINIMED |
GERDA P RESCH |
| K032037 |
07/01/2003 |
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K032033 |
07/01/2003 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K032265 |
07/23/2003 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K032312 |
07/28/2003 |
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
MEDTRONIC VASCULAR |
KRISTINA MOLLNER |
| K032138 |
07/11/2003 |
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER |
MEDTRONIC VASCULAR |
DEBORAH KIDDER |
| K032231 |
07/21/2003 |
MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K032222 |
07/21/2003 |
IMMUNOCARDSTAT HPSA |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K032143 |
07/14/2003 |
LIQUID OXYGEN SYSTEM |
MICRO TECHNOLOGY SERVICES, INC. |
TOMMY BUIE |
| K032364 |
07/31/2003 |
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K032175 |
07/16/2003 |
DESENS-IONOMER |
MILTON HODOSH, M.D. |
MILTON HODOSH |
| K032167 |
07/16/2003 |
BIO-INTRAFIX TIBIAL SCREW AND SHEATH |
MITEK WORLDWIDE |
KAREN K SYLVIA |
| K032078 |
07/07/2003 |
MITEK MICRO QUICKANCHOR |
MITEK WORLDWIDE |
SERGIO J GADALETA |
| K032234 |
07/21/2003 |
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K |
MK-DENT GMBH |
MARTINA GUNDEROTH |
| K032327 |
07/28/2003 |
MODERN MEDICAL BIPOLAR FORCEPS |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
| K032090 |
07/07/2003 |
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K032301 |
07/25/2003 |
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 |
NEOGEN TECHNOLOGIES, INC |
LYDIA B BIGGIE |
| K032238 |
07/21/2003 |
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER |
NEUROSEL (MEDICAL) LIMITED |
PETER GIBSON |
| K032196 |
07/18/2003 |
NBD DISPOSABLE RF CANNULAE |
NEW BUSINESS DEVELOPMENT, LLC |
TIMOTHY B LUSBY |
| K032188 |
07/17/2003 |
NICHOLS ADVANTAGE ALDOSTERONE ASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K032085 |
07/07/2003 |
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 |
NIDEK, INC. |
CAROL PATTERSON |
| K032256 |
07/22/2003 |
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 |
07/18/2003 |
NOMOS CORVUS 5.0M |
NOMOS CORP. |
FRANCIS X DOBSCHA |
| K032309 |
07/25/2003 |
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY |
NOVELENS, INC. |
RICHARD E LIPPMAN |
| K032180 |
07/17/2003 |
NUVASIVE CEMENT RESTRICTOR |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K032083 |
07/07/2003 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K032356 |
07/30/2003 |
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K032297 |
07/25/2003 |
DISPOSABLE N-PE MICKROKERATOME BLADES |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
| K032285 |
07/24/2003 |
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K032092 |
07/07/2003 |
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE |
OLYMPUS OPTICAL CO., LTD. |
MASAO WADA |
| K032177 |
07/16/2003 |
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TINA STEFFANIE-OAK |
| K032242 |
07/21/2003 |
PERSONNA PLUS SAFETY SCALPEL SYSTEM |
OMI MANUFACTURING PTY., LTD. |
DANIEL KAMM |
| K032305 |
07/25/2003 |
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K032296 |
07/25/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
SUSAN WERNER |
| K032288 |
07/24/2003 |
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
| K032130 |
07/11/2003 |
VITOSS-FILLED CARTRIDGE |
ORTHOVITA, INC. |
ANDREINA ANGIE IDE |
| DEN030004 |
07/03/2003 |
WEST NILE VIRUS IGM CAPTURE ELISA |
PANBIO LIMITED |
HELEN JENNINGS |
| K032119 |
07/09/2003 |
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS |
PARAGON MEDICAL, INC. |
DAVID C FURR |
| K032179 |
07/14/2003 |
COMP. E |
PARKELL, INC. |
NELSON J GENDUSA |
| K032063 |
07/03/2003 |
PEM 2400 PET SCANNER |
PEM TECHNOLOGIES |
IRVING WEINBERG |
| K032123 |
07/10/2003 |
SHOCKWAVE SUSPENSION WHEELCHAIR |
PER4MAX MEDICAL, LLC |
TIM CRISWELL |
| K032201 |
07/18/2003 |
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
| K032103 |
07/08/2003 |
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K032096 |
07/08/2003 |
PHILIPS VIEWFORUM 2003 |
PHILIPS MEDICAL SYSTEMS |
LYNN T HARMER |
| K032036 |
07/01/2003 |
GEMINI 16 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
CHRISTOF LITTWITZ |
| K032046 |
07/02/2003 |
PHILLIPS OMNIDIAGNOST ELEVA |
PHILIPS MEDICAL SYSTEMS, INC. |
LYNN HARMER |
| K032202 |
07/18/2003 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I |
PLANAR SYSTEMS, INC. |
SUSAN HAMANN |
| K032086 |
07/07/2003 |
KRYO ART CONTROLLED RATE FREEZER |
PLANER PLC |
DAVID S SCHLERF |
| K032126 |
07/10/2003 |
PROMOS SHOULDER |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K032052 |
07/02/2003 |
UC-PLUS SOLUTION UNICONDYLAR KNEE |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K032215 |
07/21/2003 |
VKS/TC-PLUS REVISION KNEE |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K032115 |
07/09/2003 |
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 |
Polyganics BV |
JAN BART HAK |
| K032112 |
07/09/2003 |
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) |
PORTEX LTD. |
STEVE OGILVIE |
| K032146 |
07/14/2003 |
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES |
PRECISION VASCULAR SYSTEMS, INC. |
RICK GAYKOWSKI |
| K032239 |
07/21/2003 |
THERA-CREAM, MODEL TCT004 |
PRIZM MEDICAL, INC. |
JULIE STEPHENS |
| K032331 |
07/29/2003 |
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) |
PRO-MED INSTRUMENTS GMBH |
JIM BAZZINOTTI |
| K032067 |
07/03/2003 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
MARTINE D SCHNEIDER |
| K032226 |
07/21/2003 |
LTV-1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K032260 |
07/22/2003 |
ARAMIS II DERMATOLOGICAL LASER |
QUANTEL MEDICAL |
ROGER W BARNES |
| K032229 |
07/21/2003 |
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM |
QUANTUM DEVICES, INC. |
MICHELE H VOVOLKA |
| K032038 |
07/01/2003 |
PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 |
QUINTON, INC. |
KAREN BROWNE |
| K032205 |
07/18/2003 |
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHN |
| K032054 |
07/02/2003 |
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K032129 |
07/10/2003 |
RADIUS 018 COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
| K032176 |
07/16/2003 |
RATTAN IMACS BY RATTAN INFORMATION CORPORATION |
RATTAN INFORMATION CORPORATION |
CARL ALLETTO |
| K032276 |
07/23/2003 |
CLICK HOLTER |
REMCO ITALIA S.P.A. |
LUIGI BUCCHI |
| K032200 |
07/18/2003 |
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH |
REMCO ITALIA S.P.A. |
DANIEL KAMM |
| K032149 |
07/14/2003 |
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR |
RITA MEDICAL SYSTEMS INC |
KAREN J FRISCHMEYER |
| K032279 |
07/24/2003 |
ONLINE TDM AMIKA |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K032089 |
07/07/2003 |
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032311 |
07/28/2003 |
ROCHE DIAGNOSTICS OMNI S ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K032334 |
07/29/2003 |
ROCHE ONLINE TDM LIDOCAINE |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K032332 |
07/29/2003 |
ROCHE ONLINE TDM QUINIDINE |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K032049 |
07/02/2003 |
ROCHE ONLINE TDM VALPROIC ACID |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K032336 |
07/29/2003 |
TINA-QUANT CRP (LATEX) |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032080 |
07/07/2003 |
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
| K032150 |
07/14/2003 |
SAFETY-MULTIFLY |
SARSTEDT, INC. |
PETER RUMSWINKEL |
| K032077 |
07/07/2003 |
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) |
SEAL POLYMER INDUSTRIES BHD. |
CHUN CHOOI FONG |
| K032293 |
07/25/2003 |
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 |
07/25/2003 |
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING |
SGMP CO., LTD. |
JANNA TUCKER |
| K032071 |
07/03/2003 |
POWDER FREE VINYL EXAMINATION GLOVE |
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. |
WILLIAM E HARRIS |
| K032084 |
07/07/2003 |
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR |
SHEN WEI (USA), INC. |
BELLE CHOU |
| K032178 |
07/16/2003 |
RHYTHM TOUCH Q 2-WAY |
SHOCKIM ENTERPRISES, LTD. |
GREG HOLLAND |
| K032165 |
07/15/2003 |
VINTAGE AL |
SHOFU DENTAL CORP. |
ROBERT NOBLE |
| K032280 |
07/24/2003 |
SIREMOBIL ISO-C 3D |
SIEMENS AG |
NEALIE HARTMAN |
| K032111 |
07/09/2003 |
ACUSON CV70 CARDIOVASCULAR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CAREY CHAVEZ |
| K032428 |
07/29/2003 |
MAGNETOM AVANTO MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
| K032114 |
07/09/2003 |
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JERRY W TSUTSUMI |
| K032224 |
07/21/2003 |
BIORCI SCREW |
SMITH & NEPHEW, INC. |
MARION W GORDON |
| K032295 |
07/25/2003 |
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K032197 |
07/18/2003 |
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 |
SMITH & NEPHEW, INC. |
JASON BILOBRAM |
| K032093 |
07/07/2003 |
PARIEFIX |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
| K032341 |
07/29/2003 |
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 |
SOTA PRECISION OPTICS, INC. |
JAY MANSOUR |
| K032219 |
07/21/2003 |
REVOLUTION SPINAL FIXATION SYSTEM |
SPINAL INNOVATIONS, INC. |
JOE CLIFT |
| K032061 |
07/03/2003 |
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH |
SPIRE BIOMEDICAL, INC. |
DONALD FICKETT |
| K032227 |
07/21/2003 |
DUREX FLAVORED LATEX CONDOM |
SSL AMERICAS, INC. |
KATHLEEN HARRIS |
| K032124 |
07/10/2003 |
DUREX PLAY LUBRICANT |
SSL AMERICAS, INC. |
KATHLEEN HARRIS |
| K032106 |
07/08/2003 |
STARBOND DENTAL BONDING ALLOYS |
STAR REFINING PRECIOUS METALS SOUTH AFRICA |
YOLANDA SMITH |
| K032246 |
07/22/2003 |
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM |
STARPLEX SCIENTIFIC, INC. |
MEHDI KARAMCHI |
| K032110 |
07/09/2003 |
PROCLASS PRESS FIT HIP STEM |
STELKAST COMPANY |
DONALD A STEVENS |
| K032062 |
07/03/2003 |
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K032213 |
07/21/2003 |
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP |
STOCKERT INSTRUMENTE GMBH |
CYNTHIA J.M. NOLTE |
| K032303 |
07/25/2003 |
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
| K032117 |
07/09/2003 |
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
| K032056 |
07/02/2003 |
BILEVEL CPAP, MODEL 9055 SERIES |
SUNRISE MEDICAL |
STEPHEN KREPELKA |
| K032042 |
07/01/2003 |
ENVISION |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K032172 |
07/16/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K032190 |
07/17/2003 |
DISPOSABLE POWDERED VINYL EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K032269 |
07/23/2003 |
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K032032 |
07/01/2003 |
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K032039 |
07/01/2003 |
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
| K032157 |
07/14/2003 |
TELEMIS-MEDICAL SOLUTION |
TELEMIS S.A. |
THOMAS J BOUCHARD |
| K032128 |
07/10/2003 |
TERUMO AL8X ARTERIAL FILTER WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K032240 |
07/21/2003 |
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K032066 |
07/03/2003 |
SONOSURG SYSTEM |
THE OLYMPUS OPTICAL CO. |
TINA STEFFANIE-OAK |
| K032101 |
07/08/2003 |
POWERSTAND STAND-UP WHEELCHAIR |
THE STANDING CO., INC. |
MICHAEL A OLVERA |
| K032064 |
07/03/2003 |
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM |
THEKEN SURGICAL,LLC |
TONY PERRY |
| K032088 |
07/07/2003 |
MODIFICATION TO THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K032330 |
07/29/2003 |
CT OIA |
THERMO BIOSTAR, INC. |
JOHN G ADAMS |
| K032230 |
07/21/2003 |
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE |
THINKLABS INC. |
RICHARD LANZILLOTTO |
| K032141 |
07/11/2003 |
SECUMAX BLOOD COLLECTION SYSTEM |
TIGER MEDITECH INCORPORATED |
SHU-CHEN CHENG |
| K032132 |
07/11/2003 |
TISSUELINK FLOATING BALL MODEL 23-201-1 |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K032079 |
07/07/2003 |
HLS NOETOS SYSTEM |
TORNIER |
Mireille Lemery |
| K032281 |
07/24/2003 |
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K032306 |
07/25/2003 |
VERSATREK |
TREK DIAGNOSTIC SYSTEMS, INC. |
NADINE M SULLIVAN |
| K032192 |
07/17/2003 |
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
| K032247 |
07/22/2003 |
U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE |
U.S. TECHNOLOGIES, INC. |
ROSINA ROBINSION |
| K032125 |
07/10/2003 |
CSTAT, MODELS 09-0014-01 AND 09-0014-02 |
VASCULAR CONTROL SYSTEMS, INC |
KATHLEEN ROBERTS |
| K032204 |
07/18/2003 |
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
DEBORAH JENSEN |
| K032102 |
07/08/2003 |
VERTELINK KOBRA SPINAL FIXATION SYSTEM |
VERTELINK CORPORATION |
GREG HOLLAND |
| K032154 |
07/14/2003 |
G-FREEZEKIT BLAST |
VITROLIFE AB |
GARY L YINGLING |
| K032155 |
07/14/2003 |
G-THAWKIT BLAST |
VITROLIFE AB |
GARY L YINGLING |
| K032047 |
07/02/2003 |
TRI-LOOP MICROWAVE ABLATION PROBE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K032073 |
07/03/2003 |
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K032168 |
07/16/2003 |
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K032228 |
07/21/2003 |
LORENZ 2.4 SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K032271 |
07/23/2003 |
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) |
WARTNER USA B.V. |
NANCY LUM-WILSON |
| K032156 |
07/14/2003 |
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT |
WFR/AQUAPLAST CORP. |
J. DAMON KIRK |
| K032174 |
07/16/2003 |
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A |
WIDE CORPORATION |
CARL ALLETTO |
| K032243 |
07/22/2003 |
MINICAT DENTOCAT |
XORAN TECHNOLOGIES, INC. |
PREDRAG SUKOVIC |
| K032363 |
07/31/2003 |
ZOLL M SERIES NIBP OPTION |
ZOLL MEDICAL CORP. |
SEAN REYNOLDS |
