FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K041811 |
09/10/2004 |
ABBOTT AXSYM TROPONIN-I ADV |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
K042146 |
09/17/2004 |
ROBOCOUCH PATIENT SUPPORT SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
K042225 |
09/10/2004 |
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
K041822 |
09/16/2004 |
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K042151 |
09/09/2004 |
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K041743 |
09/09/2004 |
ACON TRI-FECT DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K041268 |
09/20/2004 |
SILVERSITE OR CALGITROL |
ADRI |
GEORGE H SCHERR, PH.D. |
K042130 |
09/08/2004 |
AURA CPAP PATIENT INTERFACE |
AEIOMED INC. |
Gary Syring |
K041186 |
09/09/2004 |
CADDY |
AFIKIM ELECTRIC VEHICLES |
AVNER FISHBEIN |
K032922 |
09/22/2004 |
CLARISSA INFANT NCPAP CANNULA |
AIRWAYS LTD., INC. |
RICHARD J LARKIN |
K042242 |
09/15/2004 |
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES |
ALDEN OPTICAL LABS., INC. |
CHARLES H CREIGHTON |
K041734 |
09/22/2004 |
AMBU DISPOSABLE ECG ELECTRODE |
AMBU, INC. |
SANJAY PARIKH |
K042462 |
09/21/2004 |
AMERICAN DENTAL IMPLANT |
AMERICAN DENTAL IMPLANT CORPORATION |
STEVEN B LOMBARDI |
K040392 |
09/14/2004 |
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING |
AMERICAN I.V. PRODUCTS, INC. |
GREGORY FALK |
K042575 |
09/30/2004 |
AMPLIFE DIGITAL CLINICAL THERMOMETER |
AMPLIFE CORPORATION |
SUSAN D GOLDSTEIN-FALK |
K041279 |
09/23/2004 |
IMPLANTEO IMPLANTOLOGY MOTOR |
ANTHOGYR |
ERIC GENEVE |
K041566 |
09/08/2004 |
SONOSURG ULTRASONIC SURGICAL SYSTEM |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
K041795 |
09/14/2004 |
MODIFICATION TO OPTICAL SEPARATOR SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K041965 |
09/08/2004 |
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS |
ARTHREX, INC. |
SALLY FOUST |
K040070 |
09/21/2004 |
ARTELON SPACER CMC-1 |
ARTIMPLANT AB |
MARIE MARLOW |
K041269 |
09/14/2004 |
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
K041866 |
09/29/2004 |
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) |
AXIS-SHIELD DIAGNOSTICS, LTD. |
SUSAN LEONARD |
K042488 |
09/30/2004 |
PERIFIX CATHETER AND CONTIPLEX CATHETER |
B. BRAUN MEDICAL, INC. |
AMY SMITH |
K042105 |
09/23/2004 |
CLIPPER DIAGNOSTIC ELECTRODE CATHETER |
BARD ELECTROPHYSIOLOGY |
DEBORAH L HERRINGTON |
K042062 |
09/30/2004 |
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE |
BARD PERIPHERAL VASCULAR, INC. |
SHARI ALLEN |
K042015 |
09/29/2004 |
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE |
BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
ANDRES HOLLE |
K042251 |
09/17/2004 |
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
K041074 |
09/17/2004 |
BD FACSCANTO WITH BD FACSANTO SOFTWARE |
BD Biosciences |
KIM FONDA |
K042281 |
09/16/2004 |
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
BARBARA STEGMEIER |
K042195 |
09/16/2004 |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 |
BECKMAN COULTER, INC. |
KIM WALKER |
K040026 |
09/10/2004 |
BD FACS 7-COLOR SETUP BEADS |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
K040725 |
09/10/2004 |
BD FACSCANTO SYSTEM |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
KIM FONDA |
K042301 |
09/03/2004 |
PROTENS ELECTRODE |
BIO PROTECH, INC. |
E.J. EDWARD |
K042335 |
09/17/2004 |
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 |
BIO-RAD LABORATORIES, INC. |
MARIA ZEBALLOS |
K042429 |
09/16/2004 |
THE PRODIGY SYSTEM DENTAL IMPLANTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
K041002 |
09/24/2004 |
FIDIS CELIAC |
BIOMEDICAL DIAGNOSTICS S.A. |
PASCALE LAROCHE |
K041982 |
09/14/2004 |
VITEK 2 GRAM NEGATIVE ERTAPENEM |
BIOMERIEUX, INC. |
Nancy Weaver |
K041872 |
09/08/2004 |
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
K041936 |
09/08/2004 |
BIOPRO SUBTALAR IMPLANT |
BIOPRO, INC. |
DAVID MRAK |
K040591 |
09/16/2004 |
DUET SYSTEM |
BIOVIEW LTD. |
DORIT WINITZ |
K040942 |
09/15/2004 |
VST3 |
BIOWATCH MEDICAL, INC. |
URSULA E WILSON |
K042100 |
09/20/2004 |
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR |
BLACKSTONE MEDICAL, INC. |
DEAN CIPORKIN |
K041732 |
09/21/2004 |
CAVERMAP SURGICAL AID |
BLUE TORCH MEDICAL TECHNOLOGIES |
FREDERICK TOBIA |
K042065 |
09/30/2004 |
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
K041330 |
09/22/2004 |
IPLAN! FLOW |
BRAINLAB AG |
RAINER BIRKENBACH |
K041767 |
09/30/2004 |
COOLCUBE COOLPEN |
BRUCE J. SAND M.D. |
BRUCE J SAND, M.D. |
K042026 |
09/10/2004 |
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 |
C.R. BARD, INC. |
KAREN S GWOZDOWSKI GAUVIN |
K040658 |
09/29/2004 |
BARDEX I.C. LATEX FOLEY CATHETER |
C.R. BARD, INC. |
JOHN C KNORPP |
K042085 |
09/17/2004 |
CRONO F |
CANE S.R.L. |
DANIEL KAMM |
K042296 |
09/20/2004 |
BIOMARC PRELOADED TISSUE MARKER DEVICE |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
K042139 |
09/09/2004 |
VISULAS YAG III |
CARL ZEISS MEDITEC AG |
R. MICHAEL CROMPTON |
K033634 |
09/15/2004 |
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED |
CENTERPULSE ORTHOPEDICS, INC. |
AUDREY SWEARINGEN |
K042142 |
09/20/2004 |
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
K040662 |
09/08/2004 |
VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS |
CHATTANOOGA GROUP |
CHERYL BAGWELL |
K041783 |
09/28/2004 |
POLAR WAND |
CHEK-MED SYSTEMS |
ROB WHALEN |
K041791 |
09/10/2004 |
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) |
CHF SOLUTIONS, INC. |
AMY PETERSON |
K041835 |
09/28/2004 |
ENDOTINE MIDFACE B 4.5 DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
K041868 |
09/28/2004 |
VALUPEN,PROFILE |
CONMED CORPORATION |
PAMELA VETTER |
K040921 |
09/28/2004 |
COOLTOUCH, MODEL NS 160 |
COOLTOUCH, INC. |
DONALD V JOHNSON |
K040549 |
09/28/2004 |
COSMED PONY FX |
COSMED S.R.L. |
ROBERT SCHIFF |
K041655 |
09/08/2004 |
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) |
COWELL MEDI CO LTD. |
DAE KYU CHANG |
K041894 |
09/17/2004 |
ORTHOFIBER |
CP MEDICAL |
MARY ANN GREENAWALT |
K042354 |
09/21/2004 |
MODIFICATION TO: CRESCO TI IMPLANT CONCEPT |
CRESCO TI SYSTEMS AB |
J. BENGTSSON |
K042569 |
09/29/2004 |
8600 VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
K041890 |
09/22/2004 |
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 |
CRYOCOR, INC. |
JAMI MILLER |
K041627 |
09/03/2004 |
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR |
DAKO A/S |
DANA OLSEN |
K040491 |
09/10/2004 |
CHIN-UP STRIP |
DALE MILLER, INC. - THE CHIN-UP COMPANY |
DALE MILLER |
K042016 |
09/23/2004 |
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER |
DATASCOPE CORP. |
PATRICE NAPODA |
K040831 |
09/02/2004 |
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 |
DATEX-OHMEDA, INC. |
SCOTT LIGHT |
K041524 |
09/20/2004 |
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
K042233 |
09/28/2004 |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
K042325 |
09/08/2004 |
TROCHANTERIC NAIL SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
STEVE KAHN |
K041801 |
09/08/2004 |
EXPEDIUM MIS SPINE SYSTEM |
DEPUY SPINE, INC. |
JENNIFER MOONEY |
K041722 |
09/23/2004 |
MODIFICATION TO VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
K033164 |
09/07/2004 |
ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM |
DR. LEN'S MEDICAL PRODUCTS LLC |
JAY MANSOUR |
K042003 |
09/01/2004 |
INFINITY TRIDENT NMT POD |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
K042276 |
09/23/2004 |
D-VAPOR |
DRAEGER MEDICAL, INC. |
GALE E WINARSKY |
K042313 |
09/09/2004 |
INTEGRADWEB MPR/MIP |
DYNAMIC IMAGING INC. |
CARL ALLETTO |
K042159 |
09/24/2004 |
KODAK COLOR MEDICAL IMAGER 1000 |
EASTMAN KODAK COMPANY |
STEPHEN SLAVENS |
K042158 |
09/24/2004 |
KODAK MEDICAL IMAGER 300 |
EASTMAN KODAK COMPANY |
STEPHEN SLAVENS |
K042237 |
09/16/2004 |
EBI PERIARTICULAR PLATING SYSTEM |
EBI, L.P. |
PETER ALLAN |
K040903 |
09/02/2004 |
CADENCE, MODELS 2001 AND 2002 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
K041739 |
09/29/2004 |
EDWARDS E360 SURGICAL ABLATION DEVICE |
EDWARDS LIFESCIENCES, LLC. |
ELIZABETH MORAN |
K042456 |
09/23/2004 |
Lysus Infusion System |
EKOS CORP. |
JOCELYN KERSTEN |
K041522 |
09/14/2004 |
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K041647 |
09/02/2004 |
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
K042269 |
09/08/2004 |
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW |
ELEKTA INSTRUMENT AB |
ANDERS SKOGLUND |
K042008 |
09/03/2004 |
ULTRAVISUAL |
EMAGEON UV, INC. |
INGER COUTURE |
K041638 |
09/02/2004 |
TARGETSCAN BIOPSY KIT |
ENVISIONEERING, LLC. |
TOM KAPPEL |
K041637 |
09/01/2004 |
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM |
ENVISIONEERING, LLC. |
TOM KAPPEL |
K041639 |
09/02/2004 |
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM |
ENVISIONEERING, LLC. |
TOM KAPPEL |
K041442 |
09/14/2004 |
EP-4 CLINICAL STIMUTATOR |
EP MEDSYSTEMS |
JAMES E KUHN JR. |
K041021 |
09/16/2004 |
RF INTRODUCTION CANNULA |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER B LAKE |
K041139 |
09/30/2004 |
ERCHONIA EML LASER |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
K021096 |
09/08/2004 |
X-SIZER CATHETER SYSTEM |
EV3 CORPORATION |
JILL MUNSINGER |
K041906 |
09/10/2004 |
EXACTECH 12/14 TOTAL HIP SYSTEM |
EXACTECH, INC. |
GARY J MILLER |
K042223 |
09/16/2004 |
XLTEK CONNEX IP HEADBOX, MODEL 1054 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K041829 |
09/07/2004 |
FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS |
FOCUS MEDICAL, LLC. |
JOHN LEE |
K041792 |
09/24/2004 |
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K041206 |
09/15/2004 |
EPITOME SYSTEM |
GEBAUER MEDIZINTECHNIK GMBH |
KIMBERLEY DONEY |
K042257 |
09/08/2004 |
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION |
GENERAL ELECTRIC CO. |
DAVID DUERSTELER |
K042030 |
09/16/2004 |
HYPROCURE SUBTALAR IMPLANT SYSTEM |
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. |
MICHAEL GRAHAM |
K041079 |
09/28/2004 |
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 |
GUAN HONG ENTERPRISE CO., LTD. |
JENNIFER REICH |
K041237 |
09/08/2004 |
ECHOSAMPLER |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
K041285 |
09/10/2004 |
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
GYRUS MEDICAL LTD. |
ANDREW DZIMITROWICZ |
K041502 |
09/01/2004 |
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY |
HAEMOSCOPE CORP. |
ELI COHEN |
K042059 |
09/30/2004 |
SHOULDER FIXATION SYSTEM |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
K041694 |
09/13/2004 |
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
K041692 |
09/13/2004 |
INFRARED EAR THERMOMETER, ET-100 SERIES |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
K042042 |
09/21/2004 |
ULTRASOUND CAPTURE SYSTEM |
HEARTLAB, INC. |
RICHARD PETROCELLI |
K042088 |
09/02/2004 |
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 |
HEARTSINE TECHNOLOGIES, INC. |
WILLIAM J SMIRLES |
K042199 |
09/08/2004 |
TRANSLUX POWER BLUE |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
K042428 |
09/17/2004 |
SCEPTREP3 PET/CT |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLASS THISTLETHWAITE |
K042033 |
09/29/2004 |
HOVEROUND POWER WHEELCHAIR, MODEL HD700 |
HOVEROUND CORP. |
TONY DIGIOVANNI |
K041591 |
09/23/2004 |
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K041706 |
09/08/2004 |
HOFFMANN II FOOT RING |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K042019 |
09/24/2004 |
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K041709 |
09/08/2004 |
NUMELOCK II SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K042020 |
09/15/2004 |
SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) |
HUTCHINSON TECHNOLOGY, INC. |
THOMAS A DOLD |
K041867 |
09/10/2004 |
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N |
HYGIA HEALTH SERVICES, INC. |
TRACY WOOD COMAS |
K041349 |
09/24/2004 |
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM |
IBL GMBH |
Gary Lehnus |
K042507 |
09/27/2004 |
UBIPACS |
ICM CO., LTD. |
CARL ALLETTO |
K042182 |
09/01/2004 |
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 |
ICU MEDICAL, INC. |
DALE FAIRCHILD |
K042041 |
09/17/2004 |
XPLORER 1600 |
IMAGING DYNAMICS COMPANY LIMITED |
ROBIN WINSOR |
K040630 |
09/30/2004 |
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ |
IMPLEX CORP. |
MARCI HALEVI |
K042289 |
09/15/2004 |
MDI ORTHO |
IMTEC CORP. |
J. BRAD VANCE |
K041405 |
09/02/2004 |
ASPIRATION PUMP, MODEL IMD-020 |
INDUSTRIAL & MEDICAL DESIGN, INC. |
YEVGENIY KUKLIN |
K041837 |
09/24/2004 |
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED |
INNOLATEX SDN. BHD |
ELI J CARTER |
K042267 |
09/30/2004 |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP |
INOVEL LLC |
WILLIAM WAWRZYNIAK |
K042341 |
09/20/2004 |
ULTRACLIP II US |
INRAD |
MELISSA LALOMIA |
K041905 |
09/28/2004 |
HEMOSIL CALIBRATION PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K042192 |
09/02/2004 |
LOW FLOW OSV II HYDROCEPHALUS VALVE |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JUDITH E O'GRADY |
K042277 |
09/29/2004 |
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM |
INTEGRA NEUROSCIENCES, LTD. |
NIKKI HINTON |
K040915 |
09/22/2004 |
MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M |
INVIVO RESEARCH, INC. |
NEIL BATTISTE |
K040209 |
09/20/2004 |
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR |
IRIDEX CORP. |
JOHN JOSSY |
K041930 |
09/10/2004 |
VARILITE LASER SYSTEM |
IRIDEX CORPORATION |
JOHN JOSSY |
K041991 |
09/16/2004 |
ASPIREX - BONE MARROW ASPIRATE KIT |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
K042056 |
09/30/2004 |
AZ ULTRASONIC SYSTEM |
J. MORITA USA, INC. |
HOWARD ROWE |
K041914 |
09/27/2004 |
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER |
KENDALL |
JIM WELSH |
K041923 |
09/08/2004 |
BIOBLANKET |
KENSEY NASH CORP. |
DEBORAH RACIOPPI |
K032878 |
09/20/2004 |
KUNG SHIN, HMEF SK203 |
KUNG SHIN PLASTICS CO., LTD. |
JEN KE-MIN |
K042338 |
09/16/2004 |
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
K042364 |
09/30/2004 |
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES |
LAMONT MEDICAL INC |
Gary Syring |
K041883 |
09/07/2004 |
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
K041535 |
09/16/2004 |
LSC LIFESTAND COMPACT |
LIFESTAND |
CAROLANN KOTULA |
K032991 |
09/14/2004 |
LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX |
LIGHT AGE, INC. |
THOMAS C HAUCK |
K042295 |
09/16/2004 |
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 |
LINVATEC BIOMATERIALS, LTD. |
TUIJA ANNALA |
K042261 |
09/20/2004 |
MACROPORE PURICEL LIPOPLASTY SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
K033026 |
09/03/2004 |
MALLARD MODEL 3000 ANESTHESIA MACHINE |
MALLARD MEDICAL, INC. |
ROBERT M PEARSON |
K041902 |
09/22/2004 |
MANTRA ELECTRODE |
MANTRA INTL. (HK) LTD. |
ROBERT B SPERTELL |
K041520 |
09/03/2004 |
MANTRA TENS MODEL NT3 |
MANTRA INTL. (HK) LTD. |
ROBERT B SPERTELL |
K042346 |
09/20/2004 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
K031788 |
09/02/2004 |
PATHFINDER |
MASSIE RESEARCH LABORATORIES, INC. |
N.A. (BERT) MASSIE |
K041904 |
09/07/2004 |
COMPASS F10 SYSTEM |
MEDCARE FLAGA |
BERGLIND HALLGRIMSDOTTIR |
K041724 |
09/28/2004 |
COMPASS M10 SYSTEM |
MEDCARE FLAGA |
BERGLIND HALLGRIMSDOTTIR |
K033570 |
09/16/2004 |
MEDCOMP T-3 |
MEDCOMP |
JEAN CALLOW |
K041964 |
09/14/2004 |
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS |
MEDIAID INC. |
KRISTA OAKES |
K042464 |
09/30/2004 |
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
NICOHL WILDING |
K042311 |
09/09/2004 |
PACSPARTNER |
MEDICAL STANDARD CO., LTD. |
CARL ALLETTO |
K041621 |
09/13/2004 |
LITEPORT LP100 SURGICAL ILLUMINATOR |
MEDICAL VISION INDUSTRIES, INC. |
DAVID SCHLERF |
K042198 |
09/24/2004 |
PS MEDICAL NEUROSURGICAL IMPLANTS |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K041830 |
09/29/2004 |
MAGELLAN RATIO DISPENSER KIT |
MEDTRONIC PERFUSION SYSTEMS |
BRUCE BACKLUND |
K041862 |
09/15/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K041777 |
09/03/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042167 |
09/08/2004 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042235 |
09/17/2004 |
ORION ANTERIOR CERVICAL PLATING SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042194 |
09/15/2004 |
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY |
MEDTRONIC VASCULAR |
LYNN JENSEN |
K040812 |
09/02/2004 |
DETECT SURGICAL PACING AND MAPPING TOOL |
MEDTRONIC VASCULAR |
EDWARD VALDEZ |
K042190 |
09/07/2004 |
MODEL 6416 TEMPORARY PACING LEAD SYSTEM |
MEDTRONIC VASCULAR |
PAULA CORDERO |
K041381 |
09/10/2004 |
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT |
MEDTRONIC XOMED, INC. |
DAVID S DODD |
K042013 |
09/08/2004 |
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
K042187 |
09/02/2004 |
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
K040213 |
09/22/2004 |
MHLX7EC TRANSDUCER |
MICROHELIX, INC. |
CHARLES HOTTINGER |
K041435 |
09/29/2004 |
THE STRIPPER PGD |
MID-ATLANTIC DIAGNOSTICS, INC. |
SUSAN J BUSH |
K041805 |
09/21/2004 |
MICROSCOPE SYSTEM |
MIRAS MIRROR IMAGING SOLUTIONS, LTD. |
DORIT WINITZ PH.D. |
K033543 |
09/17/2004 |
NARCOTREND, MODEL COMPACT 4.0 |
MT MONITORTECHNIK GMBH & CO. KG |
FRIEDMUND WIELAND |
K040143 |
09/13/2004 |
MONORAIL |
NATS CORP. |
RICHARD LANZILLOTTO |
K042170 |
09/07/2004 |
EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 |
NEOTHERMIA CORPORATION |
SHERRIE COVAL-GOLDSMITH |
K041786 |
09/08/2004 |
CALCAMEA PLATE |
NEWDEAL S.A. |
NORMA F ESTRIN |
K041082 |
09/07/2004 |
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER |
NEWPORT MEDICAL INSTRUMENTS, INC. |
RICHARD WATERS |
K041844 |
09/03/2004 |
ALL SAFE HUBER SAFETY INFUSION SETS |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
K041779 |
09/21/2004 |
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
K041751 |
09/16/2004 |
COMPRESSION ANASTOMOSIS CLIP (CAC) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
K042113 |
09/14/2004 |
ZOE FLUID STATUS MONITOR |
NONINVASIVE MEDICAL TECHNOLOGIES, LLC. |
ALDEN KAY |
K041560 |
09/28/2004 |
FLO-ASSISTANT |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K040858 |
09/02/2004 |
ORALIEF THERAPY FOR SENSITIVE TEETH |
NOVAMIN TECHNOLOGY, INC. |
DAVID C GREENSPAN |
K041705 |
09/01/2004 |
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
K042202 |
09/10/2004 |
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
K042442 |
09/24/2004 |
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE |
ORION DIAGNOSTICA OY |
ANNIKKA RANTAMA |
K041764 |
09/09/2004 |
THE VITROS 5,1 FS CHEMISTRY SYSTEM |
ORTHO-CLINICAL DIAGNOSTICS |
CAREY A MAYO |
K042303 |
09/27/2004 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
SARAH GLOVER |
K041863 |
09/20/2004 |
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K042310 |
09/16/2004 |
ORTHO-PRO CANNULATED BONE SCREWS |
ORTHO-PRO LLC |
J.D. WEBB |
K040493 |
09/03/2004 |
OUTOLOGOUS SPINAL FIXATION SYSTEM |
ORTHOPEDIC SCIENCES, INC |
FLOYD G LARSON |
K041215 |
09/09/2004 |
CRANIAL HELMET |
OTTO BOCK HEALTH CARE, LP |
SHELLEY STOCKMAN |
K042309 |
09/08/2004 |
BIOSOMNIA-V3 |
OXFORD BIOSIGNALS LIMITED |
SIMON J GRIFFIN |
K042157 |
09/14/2004 |
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K040965 |
09/07/2004 |
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES |
PAJUNK GMBH |
LYNETTE HOWARD |
K040533 |
09/17/2004 |
EZ HUBER SAFETY INFUSION SET |
PFM MEDICAL, INC |
SALVADORE F PALOMARES |
K041578 |
09/10/2004 |
QUICKSCREEN, MODELS 9177X AND 9178X |
PHAMATECH |
CARL MONGIOVI |
K040904 |
09/16/2004 |
PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A |
PHILIPS MEDICAL SYSTEMS |
TERESA SKARR |
K042334 |
09/27/2004 |
ALLURA 3D-CA, RELEASE 1 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
K042293 |
09/08/2004 |
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
K042122 |
09/22/2004 |
SMARTINFUSER PAINPUMP |
PRECISE MEDICAL PRODUCTS |
OFER SHAI |
K042215 |
09/21/2004 |
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K041346 |
09/08/2004 |
SYNERGY ULTIMATE |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
K041129 |
09/24/2004 |
PERSONAL LUBRICATING GEL |
QUALIS, INC. |
MIKE PETERSON |
K041979 |
09/02/2004 |
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 |
QUEST MEDICAL, INC. |
JANE ANN MARTIN |
K042094 |
09/01/2004 |
R&D CBC-XE HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
K040377 |
09/16/2004 |
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES |
RADIANT INNOVATION, INC. |
FRANK LIN |
K041361 |
09/09/2004 |
RANDOX TRI LEVEL CARDIAC CONTROL |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
K041784 |
09/13/2004 |
RAVEN PROTEST - EO |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
K042490 |
09/30/2004 |
ELECSYS FOLATE II CALSET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR MT (ASCP), RAC |
K042389 |
09/14/2004 |
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K033491 |
09/01/2004 |
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
K042463 |
09/22/2004 |
HOLTER PLUS |
ROZINN ELECTRONICS, INC. |
MARK ROSOFF |
K040178 |
09/10/2004 |
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE |
S.P.O. MEDICAL EQUIPMENT, LTD. |
AHAVA STEIN |
K041941 |
09/13/2004 |
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE |
SAFE T MEDICAL DEVICES, LTD. |
DEBBIE IAMPIETRO |
K042136 |
09/08/2004 |
SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
K041749 |
09/08/2004 |
SCANDIUS ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
ERIC BANNON |
K042317 |
09/24/2004 |
CERVICAL PLATE |
SCIENT'X |
J.D. WEBB |
K042238 |
09/16/2004 |
CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES |
SEAL POLYMER INDUSTRIES BHD. |
CHUN CHOOI FONG |
K042361 |
09/29/2004 |
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D |
SEDECAL USA, INC. |
DANIEL KAMM |
K042262 |
09/10/2004 |
INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 |
SEQUAL TECHNOLOGIES, INC. |
BRIAN JARRELL |
K042214 |
09/15/2004 |
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES |
SHANDONG PERFECT PLASTIC CO., LTD. |
ALAN P SCHWARTZ |
K042213 |
09/09/2004 |
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES |
SHANDONG PERFECT PLASTIC CO., LTD. |
ALAN P SCHWARTZ |
K041954 |
09/15/2004 |
DISPOSABLE MONITORING ELECTRODES |
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
CHRIS HEALY |
K042247 |
09/02/2004 |
SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
JAMES CHU |
K042378 |
09/20/2004 |
NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE |
SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD. |
JAMES CHU |
K031370 |
09/01/2004 |
SHINMED MODE SW-988 UNTRASONIC NEBULIZER |
SHINING WORLD HEALTH CARE CO., LTD. |
JEN KE-MIN |
K040079 |
09/09/2004 |
M.L. PRIMER |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
K042229 |
09/01/2004 |
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE |
SIEMENS MEDICAL SOLUTION, INC. USA |
NEALIE HARTMAN |
K042203 |
09/24/2004 |
LEONARDO SYNGO CARDIOLOGY WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ANA LADINO |
K042328 |
09/14/2004 |
SOMATOM SPIRIT |
SIEMENS MEDICAL SYSTEMS, INC. |
NEALIE HARTMAN |
K041989 |
09/16/2004 |
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X |
SINTEA BIOTECH, INC. |
ISABELLA ELIAS |
K042072 |
09/16/2004 |
CALLOS CMF BONE VOID FILLER |
SKELETAL KINETICS, LLC |
DURAN YETKINLER |
K042312 |
09/24/2004 |
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K033341 |
09/10/2004 |
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
K042234 |
09/08/2004 |
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET |
SPECIALTY HEALTH PRODUCTS, INC. |
Mark Nelson |
K042304 |
09/08/2004 |
CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251 |
SPECTRIS TECHNOLOGIES, INC. |
STEVE GIBSON |
K042292 |
09/08/2004 |
ISITE PACS |
STENTOR, INC. |
DEANA WISEMAN |
K041127 |
09/23/2004 |
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS |
STERILMED, INC. |
BRUCE LESTER |
K041924 |
09/09/2004 |
HAUSTED POWERTRAN SERIES STRETCHER |
STERIS Corporation |
ROBERT H MCCALL |
K040901 |
09/09/2004 |
STERITEC EMU-GRAPH, MODEL NO. CI 131/US |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
K042374 |
09/23/2004 |
STOCKERT SCP RHYTHM |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
K033132 |
09/02/2004 |
STRYKER SWITCHPOINT INFINITY |
STRYKER COMMUNICATIONS CORP. |
NATHAN WOODCOCK |
K041754 |
09/07/2004 |
STRYKER MAESTRO SYSTEM |
STRYKER CORP. |
NICOLE PETTY |
K041651 |
09/30/2004 |
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
K042294 |
09/10/2004 |
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) |
SUITER ENTERPRISES, INC. |
TIMOTHY J.S. SUITER |
K041593 |
09/20/2004 |
FEATHERLIFT EXTENDED LENGTH APTOS THREAD |
SURGICAL SPECIALTIES CORP. |
RICHARD JONES |
K041617 |
09/08/2004 |
STALIF TT |
SURGICRAFT LTD. |
JANET M WEBB |
K034021 |
09/08/2004 |
VACUUM ASSISTED CORE BIOPSY DEVICE |
SUROS SURGICAL SYSTEMS, INC. |
JOSEPH L MARK |
K042226 |
09/30/2004 |
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
JAMES CHU |
K041533 |
09/01/2004 |
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS |
SYNTHES (USA) |
Lisa Boyle |
K041911 |
09/08/2004 |
SYNTHES (USA) LCP CURVED PLATES |
SYNTHES (USA) |
LISA M BOYLE |
K041860 |
09/08/2004 |
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K041611 |
09/08/2004 |
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP |
SYNTHES (USA) |
LISA M BOYLE |
K042426 |
09/22/2004 |
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) |
TAIJECT MEDICAL DEVICE CO., LTD. |
JIM-SON CHOU |
K042260 |
09/07/2004 |
PHOT-X II, MODEL 303 |
TAKARA BELMONT USA, INC. |
MASAHIRO KANAYA |
K042145 |
09/17/2004 |
READY-HEAT BLANKET |
TECHTRADE LLC |
ARTHUR M HOROWITZ |
K042010 |
09/01/2004 |
POWER SCOOTER, MODEL TL-688 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
K042011 |
09/24/2004 |
POWER SCOOTER, MODEL TL0821 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
K042012 |
09/24/2004 |
TEH LIN POWER SCOOTER, MODEL TL-822 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
K042141 |
09/28/2004 |
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE |
TELEFLEX MEDICAL |
STEVE ASTORINO |
K041437 |
09/16/2004 |
MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
K033599 |
09/16/2004 |
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
THE LAGADO CORP. |
JOHN M SZABOCSIK |
K041592 |
09/16/2004 |
CORAL SPINAL SYSTEM |
THEKEN SURGICAL |
RANDY THEKEN |
K042244 |
09/16/2004 |
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
K041660 |
09/08/2004 |
TRIMEDYNE HOLMIUM LASER SYSTEMS |
TRIMEDYNE, INC. |
GLENN YEIK |
K041771 |
09/14/2004 |
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM |
TWIN STAR MEDICAL, INC. |
JONATHAN KAHAN |
K041853 |
09/03/2004 |
OTOGRAM |
TYMPANY, INC. |
DANIEL KAMM |
K041625 |
09/08/2004 |
LTD POLYAXIAL FIXATION SYSTEM |
U.S. SPINAL TECHNOLOGIES, LLC. |
ELAINE DUNCAN |
K042326 |
09/16/2004 |
ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
IULIA NUCA |
K042280 |
09/10/2004 |
FACT PLUS ONE-STEP PREGNANCY TEST KIT |
UNIPATH LTD. |
Louise Roberts |
K042412 |
09/24/2004 |
MODIFIED SPACEMAKER SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
RENEE ALFANO |
K042342 |
09/24/2004 |
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL |
USA INSTRUMENTS, INC. |
JAMES WRENN |
K041587 |
09/28/2004 |
LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 |
VALLEYLAB |
CHARLES COPPERBERG |
K031611 |
09/29/2004 |
P4-FITNESS |
VALMED CORP. |
GUY POITOUT |
K041909 |
09/23/2004 |
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
K041528 |
09/14/2004 |
MODIFICATION TO EPTFE GRAFT |
VASCUTEK LTD. |
STEVEN ARICK |
K041516 |
09/08/2004 |
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
K041468 |
09/09/2004 |
PREMICATH, 1261.205 |
VYGON CORP. |
COURTNEY SMITH |
K042425 |
09/30/2004 |
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
K042424 |
09/30/2004 |
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
K042474 |
09/29/2004 |
ARION |
WAVELIGHT LASER TECHNOLOGIE AG |
THORSTEN CRETER |
K040479 |
09/14/2004 |
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
K041663 |
09/16/2004 |
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRIAN J YOUNG |
K042205 |
09/20/2004 |
BONE FUSION PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
K042128 |
09/08/2004 |
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) |
ZARGIS MEDICAL CORP. |
DONALD BROOKS |
K041491 |
09/20/2004 |
ZEWA MFM-007 BLOOD PRESSURE MONITOR |
ZEWA, INC. |
THOMAS ZEINDLER |
K042249 |
09/15/2004 |
CLS SPOTORNO STEM |
ZIMMER AUSTIN, INC. |
AUDREY SWEARINGEN |
K041925 |
09/24/2004 |
ST360 SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
KRISTIN JANS |
K041549 |
09/01/2004 |
ZIMMER TRABECULAR METAL HUMERAL STEM |
ZIMMER, INC. |
DALENE BINKLEY |