| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K040530 |
06/25/2004 |
MEDIA CULTURE SYSTEM |
INTL., INC. |
MICHAEL D CECCHI |
| K041550 |
06/30/2004 |
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
| K041315 |
06/10/2004 |
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
| K041165 |
06/17/2004 |
FSH MENOPAUSE PREDICTOR TEST |
ACON LABORATORIES, INC. |
FRAN WHITE |
| K041577 |
06/25/2004 |
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
RANDY VADER |
| K040817 |
06/22/2004 |
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM |
ADVANCED UROLOGICAL DEVELOPMENTS |
GERMAN BORODULIN |
| K040615 |
06/01/2004 |
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM |
ADVANCED VASCULAR DYNAMICS |
HERBERT J SEMLER |
| K040864 |
06/17/2004 |
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM |
AESCULAP |
KATHY A RACOSKY |
| K040953 |
06/23/2004 |
AESKULISA ANA HEP-2 |
AESKU, INC |
STANLEY AMMONS |
| K040712 |
06/03/2004 |
AIR SAFETY HEPA, MODEL 3500 |
AIR SAFETY LTD |
PAUL DRYDEN |
| K040874 |
06/18/2004 |
RED, WHITE & BLUE |
ALLESEE ORTHODONTIC APPLIANCES |
COLLEEN BOSWELL |
| K041026 |
06/28/2004 |
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S |
AMBU, INC. |
SANJAY PARIKH |
| K040728 |
06/18/2004 |
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K040674 |
06/30/2004 |
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES |
ANTHOGYR |
ERIC GENEVE |
| K033533 |
06/24/2004 |
POWDER FREE LATEX EXAMINATION GLOVES |
APL INTERNATIONAL INCORPORATED LIMITED |
LEE SON HONG |
| K041303 |
06/18/2004 |
LED TURBO-PEN |
APOZA ENTERPRISE CO. LTD. |
SHIN MIN TEH |
| K041686 |
06/30/2004 |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K040332 |
06/16/2004 |
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER |
ARKRAY, INC. |
HELEN LANDICHO |
| K041261 |
06/07/2004 |
FEMORAL HOOK |
ARTHROTEK, INC. |
GARY BAKER |
| K040604 |
06/04/2004 |
INNERVUE DIAGNOSTIC SCOPE SYSTEM |
ARTHROTEK, INC. |
KACY ARNOLD |
| K041158 |
06/16/2004 |
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARK |
| K033859 |
06/02/2004 |
BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
| K041191 |
06/25/2004 |
COLLEAGUE VOLUMETRIC INFUSION PUMPS |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
| K040425 |
06/14/2004 |
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K040767 |
06/07/2004 |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K041457 |
06/28/2004 |
LIQUICHEK HEMATOLOGY CONTROL (A) |
BIO-RAD |
ELIZABETH PLATT |
| K041444 |
06/09/2004 |
BIO-RAD D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
| K040030 |
06/16/2004 |
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K040683 |
06/04/2004 |
BIODERM SCIENCES WOUND DRESSING |
BIODERM SCIENCES, INC. |
EDWARD R GUBISH |
| K033174 |
06/30/2004 |
BMLS03-3 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K040882 |
06/10/2004 |
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 |
BIOMERIEUX, INC. |
SANDRA PERREAND |
| K040845 |
06/08/2004 |
VITEK 2 ESBL TEST |
BIOMERIEUX, INC. |
Nancy Weaver |
| K040610 |
06/04/2004 |
VERSA-DIAL HUMERAL HEAD |
BIOMET MANUFACTURING, INC. |
GARY BAKER |
| K033355 |
06/30/2004 |
LACTOSCREW SCREW ANCHOR |
BIOMET ORTHOPEDICS, INC. |
MARY L VERSTYNEN |
| K033489 |
06/02/2004 |
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K040611 |
06/04/2004 |
MODULAR RADIAL HEAD REPLACEMENT DEVICE |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K041331 |
06/15/2004 |
BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K040437 |
06/25/2004 |
TRIAGE PROFILER S.O.B. PANEL |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K040650 |
06/03/2004 |
BONAMATES SERIES |
BIOTECH ONE, INC. |
KAREN UYESUGI |
| K041094 |
06/17/2004 |
HSG CATHETER SET |
BIOTEQUE AMERICA, INC. |
DENIS DORSEY |
| K040149 |
06/03/2004 |
PSI-TEC PERISTALTIC INFILTRATION PUMP |
BYRON MEDICAL |
REGINA S HARRIS |
| K041546 |
06/23/2004 |
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI |
CANON INC. |
SHEILA DRISCOLL |
| K040862 |
06/30/2004 |
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM |
CARADYNE, LTD. |
JOHN O'DEA |
| K041418 |
06/10/2004 |
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER |
Cardinal Health |
LAVENIA FORD |
| K041180 |
06/07/2004 |
QUANTIX OR VESSEL STABILIZER DEVICE |
CARDIOSONIX, LTD. |
AHAVA STEIN |
| K040966 |
06/02/2004 |
MODIFICATION TO CAREMATIX WELLNESS SYSTEM |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K033048 |
06/01/2004 |
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| DEN040004 |
06/25/2004 |
CELLERATION MIST THERAPY SYSTEM |
CELLERATION |
DAVID L BREMSETH |
| K031368 |
06/22/2004 |
POWDERED LATEX SURGEON'S GLOVES |
CEPHAS MEDICAL PRIVATE LTD. |
THANGIAH IMMANUEL |
| K040579 |
06/18/2004 |
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) |
CHOLESTECH CORP. |
THOMAS E WORTHY |
| K040919 |
06/01/2004 |
NUCLEOTOME PROBE SET, MODEL 21200 |
CLARUS MEDICAL, LLC. |
TOM BARTHEL |
| K041130 |
06/10/2004 |
CDS HEMATOLOGY CALIBRATOR (CDS CAL) |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
ANDREW SWANSON |
| K041518 |
06/22/2004 |
CODMAN DURAFORM DURAL GRAFT IMPLANT |
Codman & Shurtleff, Inc. |
ELIZABETH DOLAN |
| K041296 |
06/10/2004 |
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI |
Codman & Shurtleff, Inc. |
KATHRYN WUNDER |
| K041023 |
06/15/2004 |
STAY-PUT IMPREGNATED |
COLTENE/WHALEDENT GMBH & CO. KG |
HENRY J VOGELSTEIN |
| K040700 |
06/21/2004 |
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 |
CONCENTRIC MEDICAL, INC. |
KEVIN F MACDONALD |
| K041146 |
06/08/2004 |
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG |
CONTROL SOLUTIONS, INC. |
BRETT WALACH |
| K040413 |
06/21/2004 |
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM |
CORDIS EUROPA N.V. |
KAREN WILK |
| K040994 |
06/03/2004 |
COSMEDENT CORE PASTE |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K041229 |
06/17/2004 |
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K033743 |
06/03/2004 |
COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT |
COZART BIOSCIENCE LTD. |
ROBERTO LIDDI |
| K040933 |
06/07/2004 |
ECAT HRRT |
CTI PET SYSTEMS, INC. |
M. ALAINE MEDIO |
| K041569 |
06/30/2004 |
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 |
CURELIGHT LTD |
JONATHAN S KAHN |
| K040952 |
06/29/2004 |
PRELUDE |
DANVILLE MATERIALS, INC. |
CRAIG BURNS |
| K041281 |
06/07/2004 |
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES |
DATASCOPE CORP. |
JOANN TAYLOR |
| K033896 |
06/16/2004 |
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P |
DEFIBTECH, LLC |
JOHN L ROGERS |
| K041335 |
06/16/2004 |
PTM SYSTEM |
DENTSPLY INTERNATIONAL |
P JEFFERY LEHN |
| K041372 |
06/24/2004 |
SMARTLITE PS PEN-STYLE LED CURING LIGHT |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K041343 |
06/16/2004 |
XENO NM LIGHT CURED DENTAL ADHESIVE |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K040906 |
06/16/2004 |
CALIBRA CEMENT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K041141 |
06/16/2004 |
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K041203 |
06/02/2004 |
SUMMIT OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K040655 |
06/02/2004 |
SWIFT ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE,INC |
SHARON STAROWICZ |
| K040474 |
06/23/2004 |
ACCUSOFT |
DIREX SYSTEMS CORP. |
LARISA GERSTEIN |
| K040612 |
06/17/2004 |
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
| K033785 |
06/18/2004 |
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE |
DISCUS DENTAL, INC. |
VIVIAN LAI |
| K040443 |
06/16/2004 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I |
DOME IMAGING SYSTEMS, INC. |
SUSAN HAMANN |
| K040847 |
06/17/2004 |
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR |
DRAEGER MEDICAL, INC. |
GALE E WINARSKY |
| K040642 |
06/02/2004 |
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA |
DRAEGET MEDICAL AG & CO. KGAA |
JAMES J BRENNAN |
| K040911 |
06/22/2004 |
VITALHEAT |
DYNATHERM MEDICAL, INC. |
JOHN R KANE |
| K040729 |
06/02/2004 |
SOLARIS D890 THERAPY PROBE |
DYNATRONICS CORP. |
RON HATCH |
| K041198 |
06/01/2004 |
NIC36 AMPLIFIER |
EB NEURO, S.P.A. |
CARRI GRAHAM |
| K040908 |
06/25/2004 |
EBI DISTAL RADIUS PLATING SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K033464 |
06/22/2004 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE |
EDWARDS LIFESCIENCES LLC. |
JASON SMITH |
| K041597 |
06/24/2004 |
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K034043 |
06/30/2004 |
H-FLOW VALVE |
ELCAM MEDICAL A.C.A.L. |
TALI HAZAN |
| K040071 |
06/03/2004 |
ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K040220 |
06/09/2004 |
MEDICAL AIR COMPRESSOR |
EVENT MEDICAL LTD |
ROBBIE WALSH |
| K040613 |
06/04/2004 |
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS |
EXACTECH, INC. |
GARY MILLER |
| K040755 |
06/17/2004 |
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE |
EXACTECH, INC. |
REBECCA ROBERTS |
| K041280 |
06/24/2004 |
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 |
FELTON INTERNATIONAL, INC. |
JIM STANLEY |
| K041240 |
06/02/2004 |
SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED |
FERTILITY SOLUTIONS, INC. |
SUSAN A ROTHMANN, PH.D., HCLD |
| K040956 |
06/14/2004 |
HILUX LEDMAX 3 |
FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. |
DAVID SMALL |
| K040941 |
06/10/2004 |
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K040854 |
06/30/2004 |
WEST NILE VIRUS IGM CAPTURE ELISA |
FOCUS TECHNOLOGIES, INC. |
MICHAEL J WAGNER |
| K031939 |
06/24/2004 |
BIO-EUROLIG INTERFERENCE SCREW |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K040048 |
06/07/2004 |
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM |
FUJINON, INC. |
JOSEPH M AZARY |
| K033711 |
06/03/2004 |
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K041471 |
06/29/2004 |
G-BOND |
GC AMERICA INC. |
TERRY L JORITZ |
| K041398 |
06/25/2004 |
GC FUSION |
GC AMERICA, INC. |
TERRY L JORITZ |
| K041543 |
06/22/2004 |
GE DISCOVERY ST |
GE HEALTHCARE |
LARRY A KROGER |
| K041220 |
06/15/2004 |
GE DISCOVERY ST SYSTEM |
GE MEDICAL SYSTEMS |
DAVID DUERSTELER |
| K040458 |
06/03/2004 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K040559 |
06/04/2004 |
MODIFICATION TO UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K041476 |
06/17/2004 |
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER PH.D. |
| K041521 |
06/22/2004 |
VOLUME VIEWER PLUS |
GENERAL ELECTRIC MEDICAL SYSTEMS |
LARRY KRUEGER |
| K041605 |
06/30/2004 |
PRECISION RXI ANALOG X-RAY SYSTEM |
GENERAL MEDICAL MERATE S.P.A. |
Kevin Walls |
| K040241 |
06/25/2004 |
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET |
GENZYME CORP. |
FRED D LASKY |
| K040868 |
06/04/2004 |
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH |
GENZYME CORP. |
MICHAEL G HALPIN |
| K040721 |
06/17/2004 |
ASSURE ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K041341 |
06/03/2004 |
GOLDEN SPYDER, MODEL GS-300 |
GOLDEN TECHNOLOGIES, INC. |
GENE R KULON |
| K041188 |
06/01/2004 |
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K040681 |
06/03/2004 |
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K041051 |
06/30/2004 |
RAICHEM BUN RATE REAGENT (LIQUID) |
HEMAGEN DIAGNOSTICS, INC. |
JAMES J MILLER |
| K041009 |
06/25/2004 |
RAICHEM CALCIUM (OCPC) LIQUID REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
JAMES J MILLER |
| K041052 |
06/30/2004 |
RAICHEM GLUCOSE UV (LIQUID) |
HEMAGEN DIAGNOSTICS, INC. |
JAMES J MILLER |
| K041234 |
06/10/2004 |
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM |
HEMOCUE, INC. |
R.J. SLOMOFF |
| K041580 |
06/29/2004 |
IMAGERAYI |
HENRY SCHEIN, INC. |
W. EDWARD JOHANSEN |
| K041035 |
06/09/2004 |
HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND |
HOFFRICHTER GMBH |
STEPHEN GORSKI |
| K040749 |
06/17/2004 |
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS |
HOWMEDICA OSTEONICS CORP |
MARGARET F CROWE |
| K040926 |
06/10/2004 |
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 |
HUDSON DIAGNOSTIC IMAGING LLC |
MARTIN E WENDELKEN |
| K041313 |
06/18/2004 |
STABIL-O-GRAPH |
I.E.M. GMBH |
GUENTER GINSBERG |
| K040834 |
06/03/2004 |
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K041077 |
06/25/2004 |
IMALUX OCT PROBE GUIDE |
IMALUX CORPORATION |
STEPHANIE A.S. HARRINGTON |
| K040407 |
06/03/2004 |
QUICKELISA ANTHRAX-PA KIT |
IMMUNETICS, INC. |
ANDREW LEVIN |
| K041402 |
06/16/2004 |
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
| K041590 |
06/23/2004 |
AUTODETECT SYRINGE |
INDIGO ORB, INC. |
ROBERT CHIN |
| K041500 |
06/21/2004 |
STARPACS ORTHOPEDICS SYSTEM |
INFINITT CO., LTD. |
CARL ALLETTO |
| K040885 |
06/25/2004 |
QUANTA LITE GP210 ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
| K041201 |
06/03/2004 |
ULTRACLIP II MR |
INRAD |
MELISSA LALOMIA |
| K040063 |
06/24/2004 |
INSPEKTOR PRO |
INSPEKTOR DENTAL CARE BV |
ELBERT WALLER |
| K033776 |
06/25/2004 |
INSTEAD INTIMATE LUBRICANT |
INSTEAD, INC. |
JOE PIKE |
| K033984 |
06/30/2004 |
STRAUMANN DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| K040860 |
06/17/2004 |
INTEGRA BONE FIXATION SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
DONNA R WALLACE |
| K041581 |
06/22/2004 |
COMPACS, VERSION 1.0 |
INTELLIGENT IMAGES SRL |
MAURIZIO PAIGGIO |
| K041048 |
06/04/2004 |
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
CAROLANN KOTULA |
| K040853 |
06/21/2004 |
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 |
INTERNATIONAL HOSPITAL SUPPLY CO. |
ANGELIKA SCHERP |
| K033819 |
06/04/2004 |
INVACARE 3G TARSYS |
INVACARE CORP. |
CARROLL MARTIN |
| K041108 |
06/22/2004 |
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA |
ISCIENCE SURGICAL CORPORATION |
JUDY F GORDON |
| K032767 |
06/03/2004 |
LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES |
LILY MEDICAL SUPPLIES CO., LTD. |
Ke-Min Jen |
| K041288 |
06/10/2004 |
MODIFICATION TO SMARTPIN |
LINVATEC BIOMATERIALS, INC. |
TUIJA ANNALA |
| K041204 |
06/29/2004 |
NC SP02 ADAPTER CABLE |
MASIMO CORP. |
JAMES J CRONIN |
| K041332 |
06/25/2004 |
JOEY CLAMP OPENING TOOL |
MATERNUS, INC. |
RONALD B HICKS |
| K040484 |
06/09/2004 |
MAXO2+, MODEL A AND AE |
MAXTEC, INC. |
GORDON R ROTH |
| K040659 |
06/01/2004 |
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM |
MCCUE PLC |
STEVEN PEACH |
| K041179 |
06/04/2004 |
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR |
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. |
TIM TRUITT |
| K041448 |
06/16/2004 |
HEXAPOD RT COUCHTOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
SANDOR CSABA ATS |
| K033118 |
06/28/2004 |
BIPRO MODEL SDS-CB200 |
MEDICAL SOLUTIONS INTERNATIONAL |
JACK DILLON |
| K040837 |
06/17/2004 |
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE |
MEDICEL AG |
GEORGE MYERS |
| K040746 |
06/08/2004 |
MRA-CMS |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K032948 |
06/25/2004 |
ELASTIC SKIN LIQUID BANDAGE |
MEDPAK, LLC |
JOSEPH G SANT'ANGELO |
| K040943 |
06/15/2004 |
MEDTRONIC PS MEDICAL STRATA VALVE |
MEDTRONIC NEUROSURGERY |
JEFF HENDERSON |
| K041030 |
06/30/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K041452 |
06/24/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K041282 |
06/10/2004 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K040869 |
06/01/2004 |
EXPORT CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K040699 |
06/04/2004 |
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA MAGNESON |
| K023956 |
06/17/2004 |
THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
| K040704 |
06/18/2004 |
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K040316 |
06/23/2004 |
CEDIA BUPRENORPHINE ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
| K040723 |
06/10/2004 |
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K041200 |
06/17/2004 |
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 |
MIGUN MEDICAL INSTRUMENT CO. LTD. |
EDWARD A KROLL |
| K040807 |
06/09/2004 |
MIS DENTAL IMPLANT SYSTEM |
MIS - IMPLANT TECHNOLOGIES LTD. |
MOTTI WEISMAN |
| K030831 |
06/15/2004 |
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
| K032327 |
06/15/2004 |
MODERN MEDICAL BIPOLAR FORCEPS |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
| K040238 |
06/22/2004 |
SOFTSEAL HSG CATHETER |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
AL MUZZAMMEL |
| K040663 |
06/30/2004 |
TELENABLE EMS SYSTEM |
MOLEX, INC. |
EUGENE H DIBBLE |
| K032836 |
06/18/2004 |
M3 MICROKERATOME |
MORIA S.A. |
MELANIE RENAUD-SAMIRI |
| K033512 |
06/03/2004 |
PROCYON SPINAL SYSTEM |
NAS MEDICAL TECHNOLOGIES, INC. |
MAKOTO NONAKA |
| K041212 |
06/09/2004 |
HOUVA 3 PHOTOTHERAPY SYSTEM |
NATIONAL BIOLOGICAL CORP. |
LORETTA MOONEY |
| K040310 |
06/17/2004 |
NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS |
NATIONAL DISPLAY SYSTEMS |
RON HANSEN |
| K041347 |
06/04/2004 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
| K041542 |
06/17/2004 |
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS |
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. |
WANG ZHIQIANG |
| K040813 |
06/08/2004 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K040395 |
06/01/2004 |
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K041156 |
06/09/2004 |
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 |
NONIN MEDICAL, INC. |
JOHN R DALPEE |
| K040589 |
06/03/2004 |
MODIFICATION TO AVANT 9600 PULSE OXIMETER |
NONIN MEDICAL, INC. |
JOHN R DALPEE |
| K040753 |
06/10/2004 |
R-TEST EVOLUTION 3 |
NOVACOR |
DOMINIQUE GRENIER |
| K041306 |
06/10/2004 |
NUMED PTS X SIZING BALLOON CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K040830 |
06/18/2004 |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
| K030195 |
06/17/2004 |
BBP BONE SUBSTITUTES |
OCT, USA, INC. |
Kevin Walls |
| K040689 |
06/10/2004 |
EYE SPHERE IMPLANTS |
OCULO PLASTIK, INC. |
JEAN-FRANCOIS DRETTE |
| K040900 |
06/15/2004 |
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
OPTICAL CONNECTION, INC. |
GAROLD L EDWARDS |
| K040654 |
06/04/2004 |
SENSILASE PAD 3000 |
OPTICAL SENSORS, INC. |
Gary Syring |
| K041440 |
06/25/2004 |
OPUS MAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
| K041370 |
06/24/2004 |
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
| K041322 |
06/17/2004 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
SARAH PARSONS |
| K040850 |
06/24/2004 |
TSY SHOULDER PLATE IMPLANT |
ORTHOPEDIC SCIENCES, INC |
FLOYD G LARSON |
| K041369 |
06/22/2004 |
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K040661 |
06/09/2004 |
RADENT PROPHY PASTE |
PASCAL CO., INC. |
VINCENT M TENTARELLI |
| K041214 |
06/07/2004 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K041395 |
06/09/2004 |
EG-3630UR |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K041397 |
06/09/2004 |
EG-3830UT |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K041396 |
06/09/2004 |
FG-36UX FIBER ULTRASOUND GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K041401 |
06/04/2004 |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS |
HERBERT VAN DYK |
| K041235 |
06/04/2004 |
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K040835 |
06/15/2004 |
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 |
PM DEVICES, INC. |
BRITTA DOMBOVARI |
| K033985 |
06/04/2004 |
PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 |
PM DEVICES, INC. |
BRITTA DOMBOVARI |
| K040391 |
06/02/2004 |
TOTAL BILIRUBIN REAGENT SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K040969 |
06/08/2004 |
POISE DATAENGINE |
POISE TECHNOLOGY CORPORATION |
JEN KE-MIN |
| K040364 |
06/30/2004 |
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH |
POREX SURGICAL, INC. |
HOWARD MERCER |
| K040720 |
06/03/2004 |
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K040987 |
06/18/2004 |
CRYOCHECK CLOT C |
PRECISION BIOLOGIC INC. |
STEPHEN L DUFF |
| K033402 |
06/30/2004 |
PORTABLE SLEEP DATA RECORDER (PSDR) |
PRO-TECH SERVICES, INC. |
NEIL SHELLER |
| K040791 |
06/03/2004 |
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
| K040790 |
06/03/2004 |
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K040894 |
06/22/2004 |
QBTEST |
QBTECH AB |
MARIA BERGLUND |
| K040257 |
06/14/2004 |
QUEST DIAGNOSTICS HAIRCHECK-DT (THC) |
QUEST DIAGNOSTICS, INC. |
PATRICK CARPENTER |
| K041380 |
06/08/2004 |
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR |
R2 TECHNOLOGY, INC. |
Kathy O'Shaughnessy |
| K033884 |
06/09/2004 |
RANDOX AMIKACIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K040379 |
06/16/2004 |
RANDOX IMMUNOASSAY CONTROL |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K041366 |
06/08/2004 |
IPACS ORTHO |
REAL TIME IMAGE INC. |
CARL ALLETTO |
| K040617 |
06/15/2004 |
RELIANT LASER SYSTEM II |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K040944 |
06/03/2004 |
RESCONTROL II |
RESMED LTD. |
DAVID D'CRUZ |
| K033276 |
06/07/2004 |
VPAP III ST-A |
RESMED LTD. |
DAVID D'CRUZ |
| K041412 |
06/18/2004 |
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
| K041450 |
06/18/2004 |
MODIFICATION TO NICO WITH MARS, MODEL 7300 |
RESPIRONICS NOVAMETRIX, INC. |
KEVIN MADER |
| K040187 |
06/21/2004 |
MEDICINAL LEECHES |
RICARIMPEX SAS |
BRIGITTE LATRILLE |
| K033477 |
06/10/2004 |
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT |
ROCHESTER MEDICAL CORP. |
ROB ANGLIN |
| K041385 |
06/07/2004 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
DANIEL MICHAELI |
| K040747 |
06/17/2004 |
ALADYN RIGID SPINE PLATE |
SCIENT'X |
J.D. WEBB |
| K032983 |
06/01/2004 |
SENSITIVE SKIN ANTIBACTERIAL BANDAGES |
SCIVOLUTION, INC. |
ARTHUR WARD |
| K041041 |
06/08/2004 |
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. |
WILLIAM E HARRIS |
| K040687 |
06/25/2004 |
ONEDOSE PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES INC |
TAMMY B CARREA |
| K041319 |
06/07/2004 |
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K040675 |
06/10/2004 |
AXIOM ARTIS U |
SIEMENS MEDICAL SYSTEMS, INC. |
DEBRA PEACOCK |
| K040950 |
06/21/2004 |
ALOCLAIR ORAL GEL |
SINCLAIR PHARMACEUTICALS, LTD. |
MICHAEL KILLEEN |
| K040680 |
06/14/2004 |
CONTOUR HA COATED RECONSTRUCTION RING |
SMITH & NEPHEW, INC. |
JOHN REABE |
| K040789 |
06/04/2004 |
DURABRAID SUTURE |
SMITH & NEPHEW, INC. |
BILL MCCALLUM |
| K033552 |
06/10/2004 |
JAX-TCP |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K041216 |
06/07/2004 |
SMITH & NEPHEW ULTRABRAID SUTURE |
SMITH & NEPHEW, INC. |
DENISE LIMA |
| K041455 |
06/10/2004 |
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
SONOSCAPE COMPANY LIMITED |
BOB LEIKER |
| K041050 |
06/15/2004 |
DIGORA OPTIME (OR DIGORA ONTIME) |
SOREDEX PALODEX GROUP OY |
KAI LANER |
| K033303 |
06/24/2004 |
WAFER SYSTEM |
SPINE WAVE, INC. |
RONALD K SMITH |
| K041017 |
06/25/2004 |
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K032412 |
06/10/2004 |
RE-USEABLE MICROSTAAR INJECTOR, MSI-S |
STAAR SURGICAL CO. |
JASON K LYON |
| K041383 |
06/14/2004 |
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 |
STELLARTECH RESEARCH CORP. |
GARY A SEEGER |
| K041307 |
06/14/2004 |
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K041305 |
06/14/2004 |
STRYKER BIOZIP SUTURE ANCHOR SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K041310 |
06/14/2004 |
STRYKER WEDGE SUTURE ANCHOR SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K041040 |
06/16/2004 |
VARELISA MPO ANCA, MODEL 17648/17696 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
| K041022 |
06/17/2004 |
NEUROQ - PET DP |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
| K040777 |
06/18/2004 |
LCP RADIAL HEAD PLATING SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K040701 |
06/15/2004 |
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K033868 |
06/21/2004 |
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS |
SYNTHES (USA) |
LISA M BOYLE |
| K041107 |
06/18/2004 |
TAIDOC CHECK |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K040748 |
06/02/2004 |
ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
| K033790 |
06/03/2004 |
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES |
TECNIMED S.R.L. |
CAROLANN KOTULA |
| K040135 |
06/21/2004 |
THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K041199 |
06/01/2004 |
MEDI-PUMP ASPIRATOR, MODEL 1615 |
THOMAS INDUSTRIES |
DANIEL PFISTER |
| K040713 |
06/01/2004 |
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K041557 |
06/25/2004 |
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MARY HERBERT |
| K034053 |
06/24/2004 |
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
| K041339 |
06/17/2004 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
Mireille Lemery |
| K041499 |
06/10/2004 |
SSA-770A, APLIO VERSION 5.5 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K040695 |
06/07/2004 |
21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K040697 |
06/10/2004 |
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K032438 |
06/30/2004 |
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE |
TYCO HEALTHCARE |
DAVID OLSON |
| K040511 |
06/28/2004 |
SCD EXPRESS PORTABLE COMPRESSION SYSTEM |
TYCO HEALTHCARE/KENDALL |
BRIDGET GARDNER |
| K041404 |
06/08/2004 |
CLEARBLUE EASY EASY READ PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K040494 |
06/23/2004 |
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
| K040836 |
06/10/2004 |
DISPOSABLE OVERTUBE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
| K041545 |
06/30/2004 |
CONTACT DETACH |
UNOMEDICAL A/S |
JOHN M LINDSKOG |
| K041487 |
06/17/2004 |
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT |
USA INSTRUMENTS, INC. |
JAMES WRENN |
| K040333 |
06/07/2004 |
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS |
VALUMAX INTL., INC. |
JANET JIA |
| K033960 |
06/15/2004 |
OLINDA/EXM |
VANDERBILT UNIVERSITY |
MICHAEL STABIN |
| K040730 |
06/18/2004 |
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP |
VASCULAR SOLUTIONS, INC. |
DEBORAH L NEYMARK |
| K040726 |
06/03/2004 |
VENTLAB NASAL CPAP CANNULA |
VENTLAB CORP. |
ROBERT M KELLY |
| K040898 |
06/28/2004 |
CELLSEARCH EPITHELIAL CELL CONTROL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K040171 |
06/08/2004 |
MICRODERM, MODEL/VERSION 3.5 |
VISIOMED AG |
JOHN GREENBAUM |
| K041309 |
06/30/2004 |
IMASK TM |
VITAL SIGNS, INC. |
THOMAS DIELMANN |
| K040638 |
06/07/2004 |
VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
| K041134 |
06/02/2004 |
COMBOMAP PRESSURE AND FLOW SYSTEM |
VOLCANO THERAPEUTICS, INC. |
LORRY W HUFFMAN |
| K040657 |
06/10/2004 |
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 |
VYGON S A |
LAETITIA BERNARD |
| K041124 |
06/07/2004 |
IRRIGATION TUBING SET 2.2M AND 3.8M |
W&H DENTALWERK BURMOOS |
RALF BENDA |
| K041308 |
06/28/2004 |
REMOTENURSE PATIENT MONITORING SYSTEM |
WEBVMC, LLC |
JAY MANSOUR |
| K040800 |
06/25/2004 |
WILOSN-COOK BILIARY DILATION BALLOON |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K040794 |
06/10/2004 |
INCUBATOR CAPE |
WRAPPED IN COMFORT |
JANE GETSLA |
| K041425 |
06/25/2004 |
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| K040967 |
06/16/2004 |
DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES |
ZI BO HONG WANG PLASTIC & RUBBER PRODUCTS CO. LTD. |
HUAN-CHUNG LI |
