FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K062493 |
08/25/2006 |
LAVA SOFTWARE |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
K062292 |
08/07/2006 |
UNICEM |
3M ESPE DENTAL PRODUCTS |
SABINE KRISCHER |
K062305 |
08/08/2006 |
CLARITY MODIFIED CERAMIC BRACKETS |
3M UNITEK |
L MARLYN SCHEFF |
K062337 |
08/10/2006 |
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
K062505 |
08/28/2006 |
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
K062554 |
08/30/2006 |
STARCLOSE HEX-HUB DILATOR |
ABBOTT VASCULAR INC. |
Daun Putnam |
K062582 |
08/31/2006 |
SUPRACOR BALLOON CATHETER |
ABIOMED, INC. |
ROBERT T.V. KUNG |
K062458 |
08/23/2006 |
ETHMOID SINUS SPACER |
ACCLARENT, INC. |
DEBBIE COGAN |
K062514 |
08/28/2006 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
K062331 |
08/10/2006 |
HIGHPAK-12 |
AD ELEKTRONIK GMBH |
GREGORY J MATHISON |
K062298 |
08/08/2006 |
APOLLO GAMMA CAMERA SYSTEM |
ADAC LABORATORIES |
ANNIE WRIGHT |
K062461 |
08/23/2006 |
C. ALBICANS PNA FISH |
ADVANDX, INC. |
Amy Aulwes |
K062510 |
08/28/2006 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP |
MATTHEW M HULL |
K062406 |
08/17/2006 |
AESCULAP NEURO PATTIES |
AESCULAP, INC. |
LISA M BOYLE |
K062413 |
08/17/2006 |
AESCULAP PNEUMATIC KERRISON |
AESCULAP, INC. |
KATHY A RACOSKY |
K062327 |
08/10/2006 |
MODIFICATION TO S4 SPINAL SYSTEM |
AESCULAP, INC. |
LISA M BOYLE |
K062217 |
08/01/2006 |
AESKULSKA BETA2-GLYCO-A |
AESKU, INC |
DAVID BELL |
K062434 |
08/21/2006 |
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 |
AGAMATRIX |
CONNIE HERTEL |
K062223 |
08/02/2006 |
AGFA MODEL CR30-X |
AGFA CORPORATION |
PATRICK J LYNCH |
K062390 |
08/16/2006 |
CRYSTALVIEW R200 |
ALARA, INC. |
DIANE M KING |
K062504 |
08/28/2006 |
CERAMAX |
ALPHADENT CO., LTD. |
NOH HAK |
K062371 |
08/14/2006 |
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM |
ALPHASPINE, INC. |
MIKE ENSIGN |
K062332 |
08/10/2006 |
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION |
ALTAIRE PHARMACEUTICALS, INC. |
MARTIN DALSING |
K062511 |
08/28/2006 |
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX |
ALVEOLUS, INC. |
DONALD CANAL |
K062477 |
08/24/2006 |
AMICAS VISION SERIES PACS, MODEL 4.3 |
AMICAS, INC. |
PATRICE JC NEDELEC |
K062212 |
08/01/2006 |
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S |
ANACAPA TECHNOLOGIES, INC. |
ILA DOSHI |
K062307 |
08/08/2006 |
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS |
ANULEX TECHNOLOGIES, INC |
TIMOTHY MILLER |
K062544 |
08/30/2006 |
AR1000 ULTRASONIC WOUND THERAPY SYSTEM |
AROBELLA MEDICAL, LLC |
Allison Scott |
K062365 |
08/14/2006 |
ARTHREX ASPIRATE KIT |
ARTHREX, INC. |
SALLY FOUST |
K062466 |
08/24/2006 |
ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
ANN WATERHOUSE |
K062244 |
08/03/2006 |
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR |
ARTHROCARE CORP. |
LAURA KASPEROWICZ |
K062525 |
08/28/2006 |
REPROCESSED LIGASURE VESSEL SEALER/DIVIDER |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
K062497 |
08/25/2006 |
REPROCESSED TROCARS |
ASCENT HEALTHCARE SOLUTIONS |
ELIZABETH RENKIN |
K062197 |
08/01/2006 |
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
K062277 |
08/07/2006 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE |
ATLANTIS COMPONENTS, INC. |
FRANKLIN UYLEMAN |
K062467 |
08/24/2006 |
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
ERICA CONWAY |
K062198 |
08/01/2006 |
SUNSPOTS PRE-GELLED SURFACE ELECTRODES |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
K062363 |
08/10/2006 |
BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM |
B&W TEK, INC. |
SEAN WANG |
K062441 |
08/21/2006 |
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 |
BARRX MEDICAL, INCORPORATED |
JONATHAN S KAHAN |
K062225 |
08/02/2006 |
HALO COAGULATION CATHETER |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
K062465 |
08/24/2006 |
ZYOPTIX XP EPI SEPARATOR SYSTEM |
BAUSCH & LOMB, INC. |
NED LUCE |
K062457 |
08/23/2006 |
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
K062347 |
08/10/2006 |
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
MARC HENN |
K062516 |
08/28/2006 |
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) |
BECKMAN COULTER, INC. |
TYLER FOUTCH |
K062207 |
08/01/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
K062206 |
08/01/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K062211 |
08/01/2006 |
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K062213 |
08/01/2006 |
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K062558 |
08/30/2006 |
MESOSFOL SURGICAL FILM |
BIOMET MANUFACTURING CORP. |
ERIKA MARTIN |
K062567 |
08/31/2006 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
K062530 |
08/29/2006 |
TRIAGE PROTEIN C TEST |
BIOSITE INCORPORATED |
FIL V BUENVIAJE |
K062318 |
08/09/2006 |
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
LYDIA LEE |
K062289 |
08/07/2006 |
BONART ART-L3 LED CURING LIGHT |
BONART CO. LTD. |
ERIC L ONG |
K062387 |
08/15/2006 |
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM |
BOSTON SCIENTIFIC |
ANGIE BYLAND |
K062202 |
08/01/2006 |
OCCLUSION BALLOON |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M CAMERON |
K062358 |
08/14/2006 |
MODIFICATION TO VECTORVISION TRAUMA |
BRAINLAB, AG |
RAINER BIRKENBACH |
K062221 |
08/02/2006 |
CXDI-40EC |
CANON, INC. |
SHEILA DRISCOLL |
K062340 |
08/10/2006 |
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM |
CARDIO-OPTICS, INC. |
LARRY BLANKENSHIP |
K062314 |
08/08/2006 |
HORUS LASER KERATOME |
CARL ZEISS MEDITEC AG |
KENT W JONES |
K062503 |
08/25/2006 |
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT |
CATACHEM, INC. |
LUIS P LEON |
K062400 |
08/16/2006 |
IMPRESSIX, COLORCHANGE ALGINATE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K062487 |
08/25/2006 |
APERFIX FEMORAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
Floyd Larson |
K062476 |
08/24/2006 |
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER |
CERAGEM INTERNATIONAL, INC. |
SUSAN ONEL |
K062280 |
08/07/2006 |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE |
CEREMED, INC. |
TADEUSZ WELLISZ |
K062240 |
08/02/2006 |
CAREVENT |
CHIEF MEDICAL LLC |
SCOTT HORN |
K062262 |
08/04/2006 |
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
K062200 |
08/01/2006 |
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS |
COLLAGEN MATRIX, INC. |
PEGGY HANSON |
K062215 |
08/01/2006 |
CONFIDANT 2.0 |
CONFIDANT INC. |
DANIEL R PLONSKI |
K062548 |
08/30/2006 |
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
MARTIN DALSING |
K062320 |
08/09/2006 |
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 |
COOK BIOTECH, INC. |
MARY A FADERAN |
K062438 |
08/21/2006 |
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 |
COOK OB/GYN |
CINDY RUMPLE |
K062531 |
08/29/2006 |
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
JOAN MARTIN |
K062572 |
08/31/2006 |
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE |
CUSTOM SCIENTIFIC |
PATSY J TRISLER |
K062321 |
08/09/2006 |
SMARTLIPO ND:YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
K062316 |
08/09/2006 |
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K062334 |
08/10/2006 |
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062236 |
08/02/2006 |
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K062199 |
08/01/2006 |
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062276 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062293 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062375 |
08/15/2006 |
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062290 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K062569 |
08/31/2006 |
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING |
DATASCOPE CORP. |
SUSAN MANDY |
K062397 |
08/16/2006 |
SENTINEL |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
K062469 |
08/24/2006 |
VOYAGER 12 |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
K062250 |
08/02/2006 |
DELTA XTEND REVERSE SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K062301 |
08/08/2006 |
DEPUY LPS PROXIMAL TIBIAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
K062426 |
08/18/2006 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K062352 |
08/11/2006 |
FRS SCREW |
DEPUY ORTHOPAEDICS, INC. |
REBECCA LENNARD |
K062495 |
08/25/2006 |
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM |
DEPUY SPINE, INC. |
MELANIE ARCHER |
K062196 |
08/01/2006 |
SFX SNAP-FIT CROSS CONNECTOR |
DEPUY SPINE, INC. |
MARY GRAY |
K062339 |
08/10/2006 |
DERMOTHERAP GUN |
DERMOEQUIPOS S.R.L. |
BENNY ARAZY |
K062538 |
08/29/2006 |
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM |
DIACARE CORP. |
SID MATHUR |
K062234 |
08/02/2006 |
MODIFICATION TO DIADEXUS PLAC TEST |
DIADEXUS, INC. |
ROBERT L WOLFERT |
K062433 |
08/21/2006 |
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM |
DIAMICS, INC. |
PETER GOMBRICH |
K062473 |
08/24/2006 |
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 |
DIASORIN, INC. |
CAROL A DEPOUW |
K062424 |
08/18/2006 |
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
K062388 |
08/15/2006 |
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM |
DOCUSYS |
GORDON J PETERS |
K062364 |
08/14/2006 |
I-SCOPE 200 |
DONGJIN MEDICAL CO., LTD |
MIN-KANG KIM |
K062267 |
08/04/2006 |
OXYLOG 3000 |
DRAGER MEDICAL B.V. |
BRYAN OVERTON |
K062534 |
08/29/2006 |
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE |
DRG INTL., INC. |
Gary Lehnus |
K062449 |
08/22/2006 |
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 |
E-Z-EM, INC. |
ROBERT WILLIAMS |
K062404 |
08/17/2006 |
TRANSEAR BONE CONDUCTION HEARING AID |
EAR TECHNOLOGY CORP. |
RICK GILBERT |
K062494 |
08/25/2006 |
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM |
EBI, L.P. |
DEBRA BING |
K062429 |
08/21/2006 |
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
KAREN JONES |
K062507 |
08/28/2006 |
MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K062508 |
08/28/2006 |
NEUROWAVE MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K062354 |
08/14/2006 |
VECTRA GENISYS VMS FR |
ENCORE MEDICAL, L.P. |
MICHAEL TREAS |
K062209 |
08/01/2006 |
BASX BLADELESS TROCAR |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
K062201 |
08/01/2006 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC |
BRENDA JOHNSON |
K062549 |
08/30/2006 |
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K062563 |
08/31/2006 |
FEMTEN CERVICAL TENACULUM |
FEM SUITE, L.L.C. |
CARL YOUNGMANN |
K062484 |
08/25/2006 |
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS |
FLAEM NUOVA S.P.A. |
MAUREEN O'CONNELL |
K062543 |
08/30/2006 |
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G |
FOCUS DIAGNOSTICS, INC. |
MICHEAL J WAGNER,ESQ. |
K062389 |
08/16/2006 |
Z-BLOCK, MODELS 20/19, 40/19, 55/19 |
FOUNDATION MILLING CENTRE |
IAN P GORDON |
K062576 |
08/31/2006 |
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
K062580 |
08/31/2006 |
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) |
GE HEALTHCARE |
JOEL KENT |
K062393 |
08/16/2006 |
GE VANTAGE PET NEURO SOFTWARE |
GE HEALTHCARE |
D. DUERSTELER |
K062324 |
08/09/2006 |
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN |
GE HEALTHCARE |
JOEL KENT |
K062440 |
08/21/2006 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 |
GEN-PROBE, INC. |
E JOSEPH MCMULLEN |
K062312 |
08/08/2006 |
AXIOM PULSED LIGHT SYSTEM |
GENERAL PROJECT S.R.L. |
CORNELIA DAMSKY |
K062407 |
08/17/2006 |
GATEWAY THORACOLUMBAR PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K062385 |
08/15/2006 |
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES |
Grace Medical, Inc. |
JEFF COBB |
K062547 |
08/30/2006 |
QUADRA BLOC TENS, MODEL 101 |
GRADIENT TECHNOLOGIES, LLC |
JOHN TOWNSEND |
K062245 |
08/02/2006 |
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 |
HARDY DIAGNOSTICS |
Andre Hsiung |
K062383 |
08/15/2006 |
UNISYN HA PLASMA MODULAR HIP |
HAYES MEDICAL, INC. |
LUKE ROSE |
K062448 |
08/22/2006 |
LYRA ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
K062515 |
08/28/2006 |
RETENTION FLOW OPAQUE |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
K062256 |
08/04/2006 |
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM |
HILL LABORATORIES CO. |
BRANDY ALTER |
K062556 |
08/30/2006 |
ECHELON SHOULDER COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
K063104 |
08/10/2006 |
FOX MEDICAL DIODE LASER SYSTEM 810NM |
HOWARD INSTRUMENTS, INC. |
JACK HOWARD |
K062419 |
08/18/2006 |
TRIDENT LARGE DIAMETER ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
K062498 |
08/25/2006 |
PROFYLE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K062488 |
08/25/2006 |
IQ-SYSTEM PACS SYSTEM |
IMAGE INFORMATION SYSTEMS, LTD. |
CARL ALLETTO |
K062417 |
08/18/2006 |
XPLORER 1100 |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K062405 |
08/15/2006 |
XPLORER 1590 |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K062432 |
08/21/2006 |
NANOTITE DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUELYN A HUGHES |
K062541 |
08/30/2006 |
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
INNOVA VISION INC. |
JENNIFER REICH |
K062361 |
08/14/2006 |
INNOVACON HCG UKTRA TEST DEVICE |
INNOVACON, INC. |
EDWARD TUNG |
K062261 |
08/04/2006 |
FOAM RING PORT PROTECTOR |
INSPIRED IDEAS, INCORPORATED |
Allison Scott |
K062431 |
08/21/2006 |
HEMOSIL LIQUID ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K062430 |
08/21/2006 |
HEMOSIL PROTEIN C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K062353 |
08/11/2006 |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
INTEGRA LIFESCIENCES CORPORATION |
DIANA M BORDON |
K062402 |
08/17/2006 |
EASYSTAND EVOLV |
INVACARE CORP. |
RONALD CLINES |
K062252 |
08/03/2006 |
MOLTENO3 |
IOP, INC. |
JASON MALECKA |
K062369 |
08/14/2006 |
IRIDEX OCULIGHT TX |
IRIDEX CORP. |
JOHN JOSSY |
K062259 |
08/04/2006 |
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 |
ISCIENCE SURGICAL |
GRACE BARTOO |
K062384 |
08/15/2006 |
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE |
ISORAY, INC |
DAVID J SWANBERG |
K062258 |
08/04/2006 |
GENESIS DIODE LASER |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K062218 |
08/01/2006 |
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
K062462 |
08/24/2006 |
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L |
JAWON MEDICAL CO., LTD. |
W. H PARK |
K062522 |
08/28/2006 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
JIANGSU JAYSUN GLOVE CO., LTD. |
CHU XIAOAN |
K062520 |
08/28/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
JIANGSU JAYSUN GLOVE CO., LTD. |
CHU XIAOAN |
K062439 |
08/21/2006 |
POWERTONE, MODEL PT-11 |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
K062401 |
08/16/2006 |
MODIFICATION TO LUCAS |
JOLIFE AB |
HOWARD M HOLSTEIN |
K062480 |
08/24/2006 |
JOYKEY SURGICAL DRAPES (STERILE) |
JOYKEY INDUSTRYIAL LTD. |
JENNIFER REICH |
K062479 |
08/24/2006 |
JOYKEY SURGICAL GOWNS (STERILE) |
JOYKEY INDUSTRYIAL LTD. |
JENNIFER REICH |
K062464 |
08/24/2006 |
MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K062311 |
08/08/2006 |
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 |
KARMA MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K062309 |
08/08/2006 |
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 |
KARMA MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K062227 |
08/02/2006 |
V.A.C. THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
K062412 |
08/17/2006 |
CRYOMATIC |
KEELER INSTRUMENTS, INC. |
EUGENE R VANARSDALE |
K062275 |
08/07/2006 |
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
TOM MASON |
K062519 |
08/28/2006 |
NEXUS 3 |
KERR CORPORATION |
COLLEEN BOSWELL |
K062453 |
08/22/2006 |
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 |
KINGLY STAR INTL. TECHNOLOGY CO., LTD. |
JEN KE-MIN |
K062570 |
08/31/2006 |
PATIENT CONTOURED MESH (PCM) |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K062356 |
08/14/2006 |
KOWA NONMYD ALPHA-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
K062382 |
08/15/2006 |
CLEARFIL DC BOND |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K062410 |
08/17/2006 |
CLEARFIL ESTHETIC CEMENT & DC BOND |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K062409 |
08/17/2006 |
K-ETCHANT GEL |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K062559 |
08/30/2006 |
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
K062308 |
08/08/2006 |
LMT-KATH-S; LMT-KATH-I |
LICHER MEDIZINTECHNOLOGIE GMBH |
DIETER MUSHOFF |
K062195 |
08/01/2006 |
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
CINDY MORROW |
K062242 |
08/02/2006 |
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
K062483 |
08/25/2006 |
MINI POWER CHAIR, MODEL MN 5000 |
LINE IND.(SHANGHAI) CO., LTD. |
SID MATHUR |
K062571 |
08/31/2006 |
LONGPORT EPISCAN, MODEL-I-200 |
LONGPORT, INC. |
MICHAEL G FARROW |
DEN060007 |
08/14/2006 |
INTROL CF PANEL I CONTROL |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
JOAN GORDON |
K062501 |
08/25/2006 |
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
K062535 |
08/29/2006 |
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING |
MCNEIL-PPC, INC. |
NADER FOTOUHI PH.D. |
K062474 |
08/24/2006 |
SMITHWICK CAROTID SHUNT |
MCPHERSON ENTERPRISES, INC. |
WILLIAM MCPHERSON |
K062377 |
08/15/2006 |
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 |
MEDAPPS, INC. |
KENT E DICKS |
K062229 |
08/02/2006 |
CTC WORKSTATION, MODEL 2200 |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
JAMES M BENSON |
K062482 |
08/24/2006 |
VENTED VIAL ADAPTER TRANSFER DEVICE |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
K062386 |
08/15/2006 |
QANGIO CT |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
K062295 |
08/07/2006 |
IRI INTEGRATED RETINAL IMAGER |
MEDIVISION MEDICAL IMAGING, LTD. |
AHAVA STEIN |
K062478 |
08/24/2006 |
CLAVIS |
MEDTRONIC A/S |
ANN-CHRISTINE PROVOOST |
K062348 |
08/11/2006 |
TIMESH SELF DRILLING SCREW |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K062427 |
08/18/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
EDWARD CHIN |
K062254 |
08/04/2006 |
AXIS FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD CHIN |
K062447 |
08/22/2006 |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
ED CHIN |
K062420 |
08/18/2006 |
5F SHERPA ACTIVE NX GUIDE CATHETER |
MEDTRONIC VASCULAR |
MARK PUOPOLO |
K062264 |
08/04/2006 |
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM |
MEDTRONIC VASCULAR |
JENNIFER HACKNEY |
K062421 |
08/18/2006 |
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER |
MENTOR CORPORATION |
NICOLA SELLEY |
K062490 |
08/25/2006 |
VISAGE PACS/CS, RELEASE VERSION 4.1 |
MERCURY COMPUTER SYSTEMS, INC |
RICHARD GLASHEEN |
K062546 |
08/30/2006 |
IMMUNOCARD STAT! EHEC, MODEL 751630 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K062355 |
08/14/2006 |
ENA CEM |
MICERIUM S.P.A. |
EUGENIO MICELI |
K062367 |
08/14/2006 |
MINISCREWS ANCHORING SYSTEM, M.A.S. |
MICERIUM S.P.A. |
EUGENIO MICELI |
K062302 |
08/08/2006 |
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM |
MILLICORE AB |
ROSINA ROBINSON |
K062524 |
08/28/2006 |
OCTAX LASER SHOT SYSTEM |
MINITUBE OF AMERICA, INC |
FREDERICK KIKKERS |
K062230 |
08/02/2006 |
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 |
MINRAD, INC. |
JOHN MCNEIRNEY |
K062231 |
08/02/2006 |
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 |
MINRAD, INC. |
JOHN MCNEIRNEY |
K062471 |
08/24/2006 |
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF |
MISONIX, INC. |
RONALD R MANNA |
K062436 |
08/21/2006 |
SIS SINUS IMPLANT STABILIZER |
MONDEAL MEDICAL SYSTEMS GMBH |
ANGELIKA SCHERP |
K062282 |
08/07/2006 |
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 |
MONEBO TECHNOLOGIES, INC. |
DALE J MISCZYNSKI |
K062527 |
08/28/2006 |
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
MULTISAFE SDN BHD |
ABD HADI BIN HUSIN |
K062526 |
08/28/2006 |
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE |
MULTISAFE SDN BHD |
ABD HADI BIN HUSIN |
K062205 |
08/01/2006 |
DBX STRIP |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
K062459 |
08/23/2006 |
ORIGEN DBM WITH BIOACTIVE GLASS |
NANOTHERAPEUTICS |
PAULA WILKERSON |
K062187 |
08/01/2006 |
BETACHEK GLUCOSE TEST |
NATIONAL DIAGNOSTIC PRODUCTS |
BRANDON BRANSGROVE |
K062539 |
08/29/2006 |
NCONTACT COAGULATION SYSTEM KIT |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K062284 |
08/07/2006 |
CES ULTRA |
NEURO-FITNESS LLC |
MICHAEL STEVENS |
K062533 |
08/29/2006 |
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 |
NEUROVIRTUAL USA, INC. |
EDUARDO FARIA |
K062451 |
08/22/2006 |
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
K062210 |
08/01/2006 |
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
K062551 |
08/30/2006 |
NEXUS IRRIGATION TUBING SET |
NEXUS MEDICAL, LLC |
ANITA SMITH |
K062566 |
08/31/2006 |
NOBELREPLACE TAPERED CONICAL CONNECTION |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
K062248 |
08/03/2006 |
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM |
NORTH AMERICAN CLINICAL LASERS, LTD. |
GEOFFREY D SWANK |
K062241 |
08/02/2006 |
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR |
NORTH AMERICAN SCIENTIFIC, INC. |
LEIGH SPOTTEN |
K062456 |
08/23/2006 |
NOVASPINE POWERED SUCTION PUMP PRO-1 |
NOVASPINE LLC |
DINA L WEISSMAN |
K062500 |
08/25/2006 |
FLEXPEN NEEDLE |
NOVO NORDISK INC. |
RICK SPRING |
K062317 |
08/09/2006 |
MODIFICATION TO NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K062444 |
08/21/2006 |
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT |
OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. |
CHARLES H KYPER |
K062581 |
08/31/2006 |
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
OLYMPUS AMERICA, INC. |
DAVID DAVIS |
K062517 |
08/28/2006 |
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K062423 |
08/18/2006 |
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
K062489 |
08/25/2006 |
APEX HCLA ACETABULAR CUP LINERS |
OMNILIFE SCIENCE |
EDWARD CHEAL |
K062263 |
08/04/2006 |
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 |
OMRON HEALTHCARE, INC. |
RANNDY KELLOGG |
K062416 |
08/17/2006 |
RETINAL FUNCTIONAL IMAGER (RFI) |
OPTICAL IMAGING LTD. |
JONATHAN S KAHAN |
K062336 |
08/10/2006 |
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE |
OPTIMEDICA CORPORATION |
JUDY F GORDON |
K062552 |
08/30/2006 |
RTVUE |
OPTOVUE, INC. |
JAY WEI |
K062285 |
08/07/2006 |
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K062460 |
08/23/2006 |
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K062260 |
08/04/2006 |
OSTEOBOOST-BMA |
ORTHOS LIMITED |
ALAN RORKE |
K062502 |
08/25/2006 |
OSSPRAY CLEANING COMPOUND |
OSPRAY, LTD. |
CARMELINA G ALLIS |
K062403 |
08/17/2006 |
IMAX CEPH DIGITAL X-RAY SENSOR |
OWANDY |
CLAUDE D BERTHOIN |
K062532 |
08/28/2006 |
ELECTROPULSE - LOW BACK PAIN |
PAIN RELIEF TECHNOLOGIES |
KENDALL GORHAM |
K062518 |
08/28/2006 |
CELERITY |
PARKELL, INC. |
NELSON J GENDUSA |
K062300 |
08/08/2006 |
OX-SOX, MODEL C, D, E, |
PATTIENT SAFETY INNOVATIONS, LLP |
ERIK STALHANDSKE |
K062366 |
08/14/2006 |
OPTIME, SINUSORB PGA |
PETERS SURGICAL |
ANNIE LASSERRE |
K062338 |
08/10/2006 |
TELEVISIT |
PHD MEDICAL |
NANCY RUTH |
K062271 |
08/07/2006 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
K062455 |
08/23/2006 |
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL |
PHILIPS MEDICAL SYSTEMS |
RICH MCCLEARY |
K062268 |
08/07/2006 |
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
DAVID OSBORN |
K062233 |
08/02/2006 |
HEARTSTART MRX MONITOR/DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
MICHAEL J DOYLE |
K062283 |
08/07/2006 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
ANDREAS SUCHI |
K062392 |
08/16/2006 |
PHILIPS MP5 INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
K062247 |
08/03/2006 |
HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
STEVE SINGLAR |
K062481 |
08/24/2006 |
SERENO ELECTRONIC STETHOSCOPE |
PISHON HIGH TECH CO., LTD. |
DANIEL KAMM |
K062540 |
08/30/2006 |
NASOPORE EAR, MODELS ND04, ND05 |
Polyganics BV |
JAN NIEUWENHUIS |
K062220 |
08/02/2006 |
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM |
POSSIS MEDICAL, INC. |
MARK D STENOIEN |
K062575 |
08/31/2006 |
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
K062565 |
08/31/2006 |
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
K062219 |
08/02/2006 |
PRODRIVE SYSTEMS REPLACEMENT TURBINE |
PRODRIVE SYSTEMS, INC. |
TIM NASON |
K062313 |
08/08/2006 |
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE |
PT. MAHAKARYA INTI BUANA |
VENUGOPAL NADARAJAN |
K062306 |
08/08/2006 |
PLASMACON N, PLASMACON L-1, PLASMACON L-2 |
R2 DIAGNOSTICS, INC. |
MARC GOLDFORD |
K062303 |
08/08/2006 |
FRAXEL II SR LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
K062291 |
08/07/2006 |
VPAP MALIBU WITH H2I |
RESMED LTD. |
DAVID D'CRUZ |
K062545 |
08/30/2006 |
RMI LCD ALCOHOL DETECTOR |
RESOURCE MANAGEMENT INTERNATIONAL, LLC |
DANIEL KAMM |
K062224 |
08/02/2006 |
RESPCARE HYBRID AV MASK |
RESPCARE INC. |
FRANK PELC |
K062376 |
08/15/2006 |
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI |
RF SYSTEMS LAB. |
CLAUDE D BERTHOIN |
K062578 |
08/31/2006 |
DIGI-LITE TCD DEVICE |
RIMED LTD. |
AHAVA STEIN |
K062445 |
08/22/2006 |
MONITORING EAR THERMOMETER, MODEL BTM-D1A |
RIO FLEXON TECHNOLOGY CO., LTD. |
JEFF LIAO |
K062579 |
08/31/2006 |
OMNIPICC P.I. |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
K062414 |
08/17/2006 |
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
K062395 |
08/16/2006 |
ACCU-CHEK SMART PIX |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K062319 |
08/09/2006 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K062379 |
08/15/2006 |
COBAS INTEGRA CERULOPLASMIN |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K062239 |
08/02/2006 |
GLUCOSE HK NEW FORMULATION TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
K062203 |
08/01/2006 |
TINA-QUANT D-DIMER TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
K062399 |
08/16/2006 |
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
ROB CHIOINI |
K062325 |
08/09/2006 |
RS-4I MUSCLE STIMULATOR FAMILY |
RS MEDICAL |
STEVEN CHERNOFF |
K062304 |
08/08/2006 |
DLM112 DAYLINK MONITOR |
RTX HEALTHCARE A/S |
BJARNE FLOU |
K062362 |
08/14/2006 |
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS |
SARMED SRL |
ANTONIO ROSSETTI |
K062418 |
08/18/2006 |
K-SPRAY, MODEL 085-2715 |
SCICAN |
BRENDA MURPHY |
K062335 |
08/10/2006 |
SEDECAL X PLUS LP PLUS |
SEDECAL S.A. |
DANIEL KAMM |
K062342 |
08/11/2006 |
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT |
SENTRA MEDICAL DEVICES, LLC |
KARTHIK MARAYAN |
K062204 |
08/01/2006 |
ARCHITECT CORTISOL ASSAY |
SERADYN INC. |
EARL E KNIGHT |
K062360 |
08/14/2006 |
BRANSIST SAFIRE |
SHIMADZU CORP. |
RANDAL WALKER |
K062351 |
08/11/2006 |
SYNGO DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
K062454 |
08/22/2006 |
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES |
SIEMENS MEDICAL SOLUTIONS, INC. |
JUDITH CAMPBELL |
K062506 |
08/28/2006 |
INCORIS AL |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K062509 |
08/28/2006 |
INCORIS ZI |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K062216 |
08/01/2006 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K062408 |
08/17/2006 |
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD |
SMITH & NEPHEW, INC. |
GINO ROUSS |
K062323 |
08/09/2006 |
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
K062396 |
08/16/2006 |
MODIFICATION TO STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
K062472 |
08/24/2006 |
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 |
SOURCE-RAY, INC. |
RAY MANEZ |
K062278 |
08/07/2006 |
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
K062341 |
08/10/2006 |
MALE REMEEX SYSTEM |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
K062450 |
08/22/2006 |
D-SPECT CARDIAC SCANNER SYSTEM |
SPECTRUM DYNAMICS LTD. |
AHAVA STEIN |
K062468 |
08/24/2006 |
SPECTRUM M2 MONITOR |
SPECTRUM MEDICAL, LLP |
STEVE TURNER |
K062513 |
08/28/2006 |
APEX SPINE SYSTEM |
SPINECRAFT, INC. |
AMI AKALLAL-ASAAD |
K062496 |
08/25/2006 |
OSTEOPORE TCP |
SPINECRAFT, INC. |
AMI AKALLAL-ASSAD |
K062435 |
08/21/2006 |
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS |
SPIRE BIOMEDICAL, INC. |
SHEKHAR NIMKAR |
K062251 |
08/03/2006 |
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 |
ST. JUDE MEDICAL |
GLENN JACQUES |
K062257 |
08/04/2006 |
STARION INSTRUMENTS THERMAL LITIGATING SHEARS |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
K062297 |
08/07/2006 |
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
PATRICK J MCCULLAGH |
K062333 |
08/10/2006 |
LAIMAD |
STEVEN LAMBERG, D.D.S |
JONATHAN S KAHAN |
K062553 |
08/30/2006 |
SIMPLEX P BONE CEMENT |
STRYKER ORTHOPAEDICS |
TIFFANI D ROGERS |
K062270 |
08/07/2006 |
RADIUS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062310 |
08/08/2006 |
REFLEX HYBRID ACP SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062315 |
08/09/2006 |
SUPERDIMENSION/BRONCHUS PREMIUM 2 |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
K062350 |
08/11/2006 |
SURGINETICS ADVANTAGEBLADE |
SURGINETICS |
MANETA D LOLLAR |
K062528 |
08/29/2006 |
TISSUE SITE MARKING SYSTEM |
SUROS SURGICAL SYSTEMS, INC. |
HEIDI STRUNK |
K062265 |
08/04/2006 |
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM |
SWISS MEDICAL CARE S.A. |
ROBERT AROMANDO |
K062237 |
08/02/2006 |
CADI, VERSION 4 |
SYNCA MARKETING, INC. |
STEPHANE ARSENAULT |
K062564 |
08/31/2006 |
SYNTHES LCP DISTAL FEMUR PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K062299 |
08/08/2006 |
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K062235 |
08/02/2006 |
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST |
TaiDoc Technology Corporation |
PI-SHIOU LI |
K062529 |
08/29/2006 |
BELMAX CM MODEL X168 |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
K062437 |
08/11/2006 |
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED |
TECHNOMED EUROPE |
RENE RONCKEN |
K062452 |
08/22/2006 |
KIT MENDEC SPINE AND DELIVERY SYSTEM |
TECRES SPA |
CHRISTINE BRAUER |
K062273 |
08/07/2006 |
SPACER-G TEMPORARY HIP PROSTHESIS |
TECRES SPA |
AMNON TALMOR |
K062274 |
08/07/2006 |
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 |
TECRES SPA |
DIANA TAYLOR |
K062381 |
08/15/2006 |
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K062446 |
08/22/2006 |
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K062372 |
08/14/2006 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
K062475 |
08/24/2006 |
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM |
THE LARYNGEAL MASK CO.,LTD. |
FOSTER BOOP |
K062521 |
08/28/2006 |
OXALATE URINE CONTROLS (NORMAL AND ELEVATED) |
THERMO-ELECTRON CORP. |
MELITA LAMBIRIS |
K062391 |
08/16/2006 |
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
K062428 |
08/18/2006 |
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS |
TRIPATH IMAGING, INC. |
BRYAN J TUCKER |
K062523 |
08/28/2006 |
TRU-MR LARYNGOSCOPE SET |
TRUPHATEK INTERNATIONAL, LTD. |
PAUL DRYDEN |
K062238 |
08/02/2006 |
TYTAN BLOOD PRESSURE CUFF |
TYTAN MEDICAL CORP. |
Ke-Min Jen |
K062577 |
08/31/2006 |
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC |
TZ MEDICAL, INC. |
MADALYN DUNCAN |
K062222 |
08/02/2006 |
UNITIP HIGH RESOLUTION CATHETER |
UNISENSOR AG |
ROBERT N CLARK |
K062326 |
08/09/2006 |
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
Daniel Campion |
K062422 |
08/18/2006 |
HUMERAL HEAD, MANUAL DRIVER |
VIDACARE CORPORATION |
GRACE HOLLAND |
K062555 |
08/30/2006 |
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G |
VISGENEER, INC. |
Ke-Min Jen |
K062328 |
08/10/2006 |
VITREAACCESS, VERSION 1.0 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K062345 |
08/11/2006 |
CERAMIC BOND |
VOCO GMBH |
MICHAEL SUES |
K062343 |
08/11/2006 |
GRANDIO FLOW TRY-IN |
VOCO GMBH |
MICHAEL SUES |
K062344 |
08/11/2006 |
GRANDIO SEAL |
VOCO GMBH |
MICHAEL SUES |
K062425 |
08/18/2006 |
LIFECATH S PICC AND MIDLINE CATHETER |
VYGON CORP. |
COURTNEY SMITH |
K062380 |
08/15/2006 |
FLOSIMPLE ARTHROSCOPY PUMP A120 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
K062368 |
08/14/2006 |
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
K062214 |
08/01/2006 |
BRACHYSCIENCES STRANDPORT |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
WAYNE W RICHARDSON |
K062542 |
08/30/2006 |
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX |
Z-Systems AG |
FLOYD G LARSON |
K062281 |
08/07/2006 |
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 |
ZIMMER DENTAL INC. |
ERIN L MCVEY |
K062228 |
08/02/2006 |
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION |
ZIMMER, INC. |
PATRICIA JENKS |
K062537 |
08/29/2006 |
ZOLL M SERIES WITH REAL CPR HELP |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |