FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K062505 |
09/26/2006 |
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
K062458 |
09/15/2006 |
ETHMOID SINUS SPACER |
ACCLARENT, INC. |
DEBBIE COGAN |
K062514 |
09/28/2006 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
K062059 |
09/06/2006 |
AIE REGION OF INTEREST IMAGE ENHANCEMENT |
ADVANCED IMAGE ENHANCEMENT |
JILLIAN M REED |
K062406 |
09/15/2006 |
AESCULAP NEURO PATTIES |
AESCULAP, INC. |
LISA M BOYLE |
K060762 |
09/14/2006 |
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM |
AESCULAP, INC. |
MATTHEW M HULL |
K062048 |
09/07/2006 |
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM |
AESTHERA CORPORATION |
ANNE WORDEN |
K062223 |
09/01/2006 |
AGFA MODEL CR30-X |
AGFA CORPORATION |
PATRICK J LYNCH |
K062390 |
09/18/2006 |
CRYSTALVIEW R200 |
ALARA, INC. |
DIANE M KING |
K062504 |
09/05/2006 |
CERAMAX |
ALPHADENT CO., LTD. |
NOH HAK |
K052544 |
09/29/2006 |
PULSE OXIMETER ADAPTER CABLES |
AMERICAN I.V. PRODUCTS, INC. |
GREGORY FALK |
K061850 |
09/29/2006 |
MINI-YAG LASER |
AMERICAN LASERS, INC. |
DAVID K QUON |
K062307 |
09/01/2006 |
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS |
ANULEX TECHNOLOGIES, INC |
TIMOTHY MILLER |
K061763 |
09/19/2006 |
ARC SURGICAL BIOTRAK SCREW |
ARC SURGICAL LLC. |
ED BOEHMER |
K062365 |
09/29/2006 |
ARTHREX ASPIRATE KIT |
ARTHREX, INC. |
SALLY FOUST |
K062679 |
09/27/2006 |
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES |
ARTHREX, INC. |
NANCY HOFT |
K062747 |
09/29/2006 |
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM |
ARTHREX, INC. |
ANN WATERHOUSE |
K061776 |
09/25/2006 |
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE |
ARTHROTEK, INC. |
PATRICIA SANDBORN BERES |
K061759 |
09/05/2006 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
K060787 |
09/27/2006 |
TATTOOSTAR FAMILY |
ASCLEPION LASER TECHNOLOGIES GMBH |
REINHARD THIEME |
K061856 |
09/28/2006 |
V-2200 INFANT INCUBATOR |
ATOM MEDICAL INC |
MARY STANIEWICZ |
K062159 |
09/05/2006 |
RB12 SUCTION RECTAL BIOPSY SYSTEM |
AUS SYSTEMS PTY LTD. |
IAN P GORDON |
K061422 |
09/25/2006 |
SURGICAL DRAPES |
AUSTIN MEDICAL, INC. |
PAUL DRYDEN |
K060182 |
09/07/2006 |
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE |
AUSTRALIAN SURGICAL DEVICES |
MARIO KUNA |
K060165 |
09/01/2006 |
AXYAFLEX POLYESTER SUTURE |
AXYA MEDICAL, INC. |
Howard Schrayer |
K061924 |
09/05/2006 |
CORONIS 3MP AND MDCG 3120-CB |
BARCOVIEW |
LIEVEN DE WANDEL |
K061928 |
09/05/2006 |
CORONIS COLOR 2MP AND MDCC 2121 |
BARCOVIEW |
LIEVEN DE WANDEL |
K061927 |
09/05/2006 |
CORONIS COLOR 3MP AND MDCC 3120-DL |
BARCOVIEW |
LIEVEN DE WANDEL |
K062465 |
09/06/2006 |
ZYOPTIX XP EPI SEPARATOR SYSTEM |
BAUSCH & LOMB, INC. |
NED LUCE |
K061515 |
09/11/2006 |
RENALSOFT |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
K062457 |
09/21/2006 |
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
K062058 |
09/11/2006 |
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 |
BAYER HEALTHCARE |
ROGER SONNENBERG |
K062087 |
09/14/2006 |
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 |
BD Biosciences |
CARTER NAVARRO |
K061190 |
09/15/2006 |
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 |
BECKMAN COULTER, INC. |
VALYNDA L MACHEN |
K062207 |
09/13/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
K062206 |
09/08/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K061744 |
09/15/2006 |
COCHLEA-SCAN / COCHLEA-SCAN PLUS |
BIO-LOGIC SYSTEMS CORP. |
NORMAN BRUNNER |
K061311 |
09/22/2006 |
ALLOGRAN-R |
BIOCOMPOSITES LTD. |
SIMON FITZER |
K061949 |
09/25/2006 |
DOUBLEPLAY SUTURE ANCHOR |
BIOCOMPOSITES LTD. |
SIMON FITZER |
K062141 |
09/13/2006 |
MAMMOPAD RADIOLUCENT CUSHION |
BIOLUCENT, INC. |
SHERYL HIGGINS |
K061945 |
09/19/2006 |
VITEK 2 AST-YS FLUCONAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
K061340 |
09/25/2006 |
23 MM SINGLE-PEG PATELLA COMPONENT |
BIOMET MANUFACTURING, INC. |
LESTER F PADILLA |
K061787 |
09/21/2006 |
MAXFORCE TTS SINGLE-USE BALLOON DILATOR |
BOSTON SCIENTIFIC CORP. |
WING NG |
K061877 |
09/15/2006 |
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
ELENA BICKOFF |
K061231 |
09/01/2006 |
WELLFLEX BILIARY RX STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
ALLYSON BARFORD |
K062594 |
09/20/2006 |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
Boston Scientific Corporation |
SARAH PETERSON |
K061884 |
09/06/2006 |
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 |
BOVIE MEDICAL |
RICHARD KOZLOFF |
K061764 |
09/06/2006 |
MEDIBYTE, MODEL MP8 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
K062086 |
09/20/2006 |
NAVIVISION |
BRAINLAB AG |
RAINER BIRKENBACH |
K061394 |
09/06/2006 |
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
K062164 |
09/22/2006 |
RESOLUTIONMD, VERSION 1.3 |
CALGARY SCIENTIFIC, INC. |
PIERRE LEMIRE |
K061528 |
09/22/2006 |
SELFCHECK GLUCO |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K061932 |
09/14/2006 |
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE |
CARDIOPULMONARY CORP. |
JORDAN SCHRECK |
K061075 |
09/01/2006 |
BOOMERANG WIRE |
CARDIVA MEDICAL, INC. |
GLENN FOY |
K061960 |
09/05/2006 |
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K062031 |
09/27/2006 |
CHASE CARDIAC ANALYSIS SYSTEM |
CHASE MEDICAL, LP |
DAVID M HERNON |
K061568 |
09/29/2006 |
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
Codman & Shurtleff, Inc. |
JOCELYN RAPOSO |
K061967 |
09/25/2006 |
SCD GARMENT, MODEL VP530 |
COMPRESSION THERAPY CONCEPTS, INC. |
LEN NASS |
K052206 |
09/12/2006 |
ZEUS MALE CONDOM APPLICATOR |
CONDAX LLC. |
ELI J CARTER |
K061972 |
09/18/2006 |
CONNECT IMAGING PACS |
CONNECT IMAGING, INC. |
PHILIP J MANLY |
K060623 |
09/06/2006 |
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
COOK IRELAND LTD |
EMMETT DEVEREUX |
K062531 |
09/22/2006 |
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
JOAN MARTIN |
K060482 |
09/28/2006 |
CYTORI CELUTION CELL CONCENTRATION DEVICE |
CYTORI THERAPEUTICS, INC. |
KENNETH K KLEINHENZ |
K061825 |
09/06/2006 |
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062316 |
09/06/2006 |
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K061852 |
09/22/2006 |
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K061802 |
09/11/2006 |
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062334 |
09/22/2006 |
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061990 |
09/19/2006 |
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K061795 |
09/11/2006 |
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
PAMELA A JUNGA |
K062034 |
09/06/2006 |
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062199 |
09/06/2006 |
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062162 |
09/14/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062182 |
09/14/2006 |
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062585 |
09/19/2006 |
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN |
DADE BEHRING, INC. |
SHANNON POPSON |
K062290 |
09/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K062596 |
09/19/2006 |
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID |
DADE BEHRING, INC. |
SHANNON POPSON |
K052532 |
09/05/2006 |
IMAX 9.5 STERILIZERS |
DENTAL X SRL |
CYNTHIA J.M. NOLTE |
K061658 |
09/18/2006 |
SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L |
DENTALL CORP. |
EDWIN FIRST |
K061648 |
09/11/2006 |
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
K062654 |
09/29/2006 |
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
K062196 |
09/11/2006 |
SFX SNAP-FIT CROSS CONNECTOR |
DEPUY SPINE, INC. |
MARY GRAY |
K052536 |
09/13/2006 |
ALGICELL AG |
DERMA SCIENCES CANADA, INC. |
DELA SHARMINI ATHERAY |
K062234 |
09/11/2006 |
MODIFICATION TO DIADEXUS PLAC TEST |
DIADEXUS, INC. |
ROBERT L WOLFERT |
K060333 |
09/08/2006 |
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM |
DIALYSIS SERVICES, INC. |
MIKE STERLING |
K061797 |
09/01/2006 |
SM IMPLANT SYSTEMS |
DIO DEPARTMENT DSI, INC. |
DAE KYU CHANG |
K062758 |
09/27/2006 |
OWL URF-3AP |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
K062424 |
09/14/2006 |
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
K061864 |
09/15/2006 |
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 |
DUKAL CORP. |
PATRICK J LAMB |
K062404 |
09/08/2006 |
TRANSEAR BONE CONDUCTION HEARING AID |
EAR TECHNOLOGY CORP. |
RICK GILBERT |
K062429 |
09/27/2006 |
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
KAREN JONES |
K061134 |
09/01/2006 |
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES |
EFS EBERLE FEINWERKTECHNISCHE SYSTEME |
GERALD GOIGITZER |
K060329 |
09/11/2006 |
ENDOFAST RELIANT SYSTEM |
ENDOGUN MEDICAL SYSTEMS |
YORAM LEVY |
K061597 |
09/27/2006 |
EPOC BLOOD ANALYSIS SYSTEM |
EPOCAL, INC. |
ROY LAYER |
K061992 |
09/19/2006 |
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 |
EPS BIO TECHNOLOGY CORP. |
Y C LEI |
K061770 |
09/25/2006 |
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM |
ETHICON ENDO-SURGERY, INC. |
TOM BOSTICCO |
K062000 |
09/25/2006 |
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH |
ETHICON ENDO-SURGERY, INC. |
CAROL WALSH |
K060700 |
09/08/2006 |
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. |
EUROIMMUN US LLC |
KATHRYN KOHL |
K061668 |
09/12/2006 |
OPTECURE +CCC |
EXACTECH, INC. |
MARITZA ELIAS |
K060734 |
09/05/2006 |
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
K062576 |
09/29/2006 |
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
K062393 |
09/01/2006 |
GE VANTAGE PET NEURO SOFTWARE |
GE HEALTHCARE |
D. DUERSTELER |
K061741 |
09/15/2006 |
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM |
GE HEALTHCARE |
ALLEN TABOR |
K061942 |
09/29/2006 |
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 |
GE HEALTHCARE |
JOEL C KENT |
K062039 |
09/11/2006 |
BIOPSY DIGIT-AM |
GIOTTO USA, LLC |
Allison Scott |
K061735 |
09/08/2006 |
INFIBRA, MODEL 1200 |
GLOBAL DENTAL PRODUCTS, INC. |
JERRY BARTICK |
K062407 |
09/06/2006 |
GATEWAY THORACOLUMBAR PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K062385 |
09/27/2006 |
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES |
Grace Medical, Inc. |
JEFF COBB |
K061690 |
09/15/2006 |
SURGICAL HEADLIGHT |
GULF MEDICAL FIBEROPTICS |
MARCELINO AFANADOR |
K061611 |
09/11/2006 |
BOSWORTH DENTIN RESIN |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
K062448 |
09/20/2006 |
LYRA ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
K060765 |
09/06/2006 |
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 |
HEMOCUE AB |
ALLEN WHITE |
K061138 |
09/29/2006 |
ABX PENTRA 400 : CRP |
HORIBA ABX |
TIM LAWTON |
K061432 |
09/11/2006 |
HOSPIRA ENTERAL FEEDING SET, MODEL 20640 |
HOSPIRA, INC. |
DIANE RENNPFERD |
K061573 |
09/19/2006 |
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT |
HOSPIRA, INC. |
THOMAS KOZMA |
K062488 |
09/19/2006 |
IQ-SYSTEM PACS SYSTEM |
IMAGE INFORMATION SYSTEMS, LTD. |
CARL ALLETTO |
K062417 |
09/15/2006 |
XPLORER 1100 |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K062405 |
09/13/2006 |
XPLORER 1590 |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K062586 |
09/29/2006 |
XPLORER 1600 PLUS |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K061979 |
09/22/2006 |
MODIFICATION TO MYALLERGY TEST |
IMMUNETECH CORPORATION |
NANCY BENSON |
K061319 |
09/29/2006 |
SPECTRA SYSTEM |
IMPLANT DIRECT LLC |
LESLIE TERRY |
K061974 |
09/15/2006 |
GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K061598 |
09/22/2006 |
HEMOSIL HOMOCYSTEINE AND CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K062431 |
09/01/2006 |
HEMOSIL LIQUID ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K062430 |
09/01/2006 |
HEMOSIL PROTEIN C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K062599 |
09/27/2006 |
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS |
INTEGRA LIFESCIENCES CORPORATION |
DARLENE M WELSH |
K053540 |
09/06/2006 |
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE |
INTERMEDIC ARFRAN, S.A. |
KLAUS SIVEC |
K062402 |
09/21/2006 |
EASYSTAND EVOLV |
INVACARE CORP. |
RONALD CLINES |
K061874 |
09/05/2006 |
INVACARE'S TWILIGHT II NASAL MASKS |
INVACARE CORP. |
JANICE BROWNLEE |
K062252 |
09/27/2006 |
MOLTENO3 |
IOP, INC. |
JASON MALECKA |
K061781 |
09/05/2006 |
MULTILINK SPRINT |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K060882 |
09/01/2006 |
EXCEL BOND DC, MODEL 28-200100 |
J. MORITA USA, INC. |
HOWARD ROWE |
K061664 |
09/08/2006 |
FORMCORE DC, MODEL 28-700100 |
J. MORITA USA, INC. |
TAKESHI INOUE |
K062462 |
09/29/2006 |
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L |
JAWON MEDICAL CO., LTD. |
W. H PARK |
K062522 |
09/08/2006 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
JIANGSU JAYSUN GLOVE CO., LTD. |
CHU XIAOAN |
K062401 |
09/28/2006 |
MODIFICATION TO LUCAS |
JOLIFE AB |
HOWARD M HOLSTEIN |
K060917 |
09/22/2006 |
KENSEY NASH BONE VOID FILLER |
KENSEY NASH CORPORATION |
JENNIFER J BOSLEY |
K062275 |
09/20/2006 |
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
TOM MASON |
K052870 |
09/29/2006 |
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 |
KIMBERLY-CLARK CORP. |
TIERNEY NORSTED |
K051165 |
09/07/2006 |
KLS MARTIN STERNAL TALON |
KLS-MARTIN L.P. |
JENNIJER DAMATO |
K061507 |
09/21/2006 |
SONICWELD RX ENDOBROW FIXATION |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K062356 |
09/27/2006 |
KOWA NONMYD ALPHA-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
K061906 |
09/28/2006 |
CLEARFIL CERAMIC PRIMER |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K062382 |
09/27/2006 |
CLEARFIL DC BOND |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K062410 |
09/26/2006 |
CLEARFIL ESTHETIC CEMENT & DC BOND |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K061860 |
09/18/2006 |
CLEARFIL MAJESTY ESTHETIC |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K060153 |
09/29/2006 |
ACUMED LASER, MODEL 1000 |
LASER THERA, LLC |
SHELLY HENRY |
K061871 |
09/20/2006 |
LEICA MODEL FL800 |
LEICA MICROSYSTEMS, INC. |
MAX STURGIS |
K061023 |
09/20/2006 |
THERMOSUIT SYSTEM |
LIFE RECOVERY SYSTEMS HD, LLC |
PAUL A TENTHOREY |
K061364 |
09/05/2006 |
PILOT POSTERIOR LUMBAR PLATING SYSTEM |
LIFE SPINE |
ERIN MALLOY |
K061966 |
09/27/2006 |
LITETOUCH DENTAL LASER SYSTEM |
LIGHT INSTRUMENT LTD |
YORAM LEVY |
K062242 |
09/29/2006 |
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
K062483 |
09/08/2006 |
MINI POWER CHAIR, MODEL MN 5000 |
LINE IND.(SHANGHAI) CO., LTD. |
SID MATHUR |
K061742 |
09/06/2006 |
URYXXON RELAX URINE ANALYZER |
MACHEREY-NAGEL GMBH & CO., KG. |
ARMOND WELCH |
K060847 |
09/26/2006 |
MAGSTIM 200-2 |
MAGSTIM COMPANY US, LLC. |
REZA JALINOUS |
K062501 |
09/29/2006 |
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
K061473 |
09/21/2006 |
SURGI-WRAP MAST BIORESORBABLE SHEET |
MAST BIOSURGERY USA INC. |
KENNETH K KLEINHENZ |
K061502 |
09/15/2006 |
MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
K062229 |
09/11/2006 |
CTC WORKSTATION, MODEL 2200 |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
JAMES M BENSON |
K061731 |
09/06/2006 |
MEDGRAPHICS ULTIMA SYSTEM |
MEDICAL GRAPHICS CORP. |
LYNN BROSIOUS |
K062611 |
09/20/2006 |
IGUIDE SYSTEM |
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA |
MICHAEL WOLFF |
K062639 |
09/21/2006 |
MODIFICATION TO HEXAPOD RT COUCH TOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA |
MICHAEL WOLFF |
K061339 |
09/19/2006 |
HIERSPEC SPECULUM |
MEDICAL PRODUCTS DIV. |
THOMAS W COPELAND |
K062119 |
09/22/2006 |
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 |
MEDICAL PRODUCTS MFG., LLC |
ROSINA ROBINSON |
K060681 |
09/15/2006 |
MEDTRONIC PS MEDICAL STRATA TYPE VALUE |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K062348 |
09/08/2006 |
TIMESH SELF DRILLING SCREW |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K062606 |
09/25/2006 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
EDWARD S CHIN |
K061635 |
09/05/2006 |
MSD BIPOLAR FORCEPS |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
K062427 |
09/12/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
EDWARD CHIN |
K061591 |
09/08/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K062133 |
09/26/2006 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SPINAL AND BIOLOGICS DIV |
LEE GRANT |
K062420 |
09/08/2006 |
5F SHERPA ACTIVE NX GUIDE CATHETER |
MEDTRONIC VASCULAR |
MARK PUOPOLO |
K061958 |
09/05/2006 |
MEDTRONIC EXPORT XT CATHETER |
MEDTRONIC VASCULAR |
KAREN A BROZOWSKI |
K061557 |
09/15/2006 |
FUSION |
MEDWAVE, INC. |
DONNA R LUNAK |
K061809 |
09/13/2006 |
ARTEGRAL IMCROWN |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
K061471 |
09/11/2006 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K061092 |
09/13/2006 |
BAXTER DUPLOSPRAY MIS APPLICATOR |
MICROMEDICS, INC. |
THOMAS LOPAC |
K062163 |
09/22/2006 |
MIMVIEWER |
MIMVISTA CORP. |
PETER SIMMELINK |
K052492 |
09/05/2006 |
AIRNERGY+STREAM |
NATURAL ENERGY SOLUTIONS AG |
MARTINA GUNDEROTH |
K062451 |
09/28/2006 |
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
K062210 |
09/25/2006 |
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
K061618 |
09/25/2006 |
COOLTOUCH, MODEL CTEV |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
K060644 |
09/18/2006 |
AHMED GLAUCOMA VALVE, MODEL M4 |
NEW WORLD MEDICAL, INC. |
A. MATEEN AHMED |
K061768 |
09/28/2006 |
MP-1 MICROPERIMETER |
NIDEK TECHNOLOGIES SRL |
ALDO COCCHIGLIA |
K062020 |
09/05/2006 |
LIFESOUND ESOPHAGEAL STETHOSCOPE |
NOVAMED, LLC |
PAUL DRYDEN |
K062317 |
09/01/2006 |
MODIFICATION TO NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K062610 |
09/28/2006 |
CARE-E-VAC 3 |
OHIO MEDICAL CORPORATION |
HOBY CHAE |
K062049 |
09/22/2006 |
EVIS EXERA II 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K062423 |
09/21/2006 |
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
K061524 |
09/26/2006 |
ISS INTEGRATED SPINE SYSTEM |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
K060770 |
09/15/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
SARAH PARSONS |
K060678 |
09/14/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
SARAH PARSONS |
K052968 |
09/08/2006 |
MODIFICATION TO: ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN CAMBRIA |
K062072 |
09/22/2006 |
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K061494 |
09/21/2006 |
DERMADAPT WOUND DRESSING |
PEGASUS BIOLOGICS, INC. |
PAMELA MISAJON |
K061695 |
09/14/2006 |
LED PROLUX 770 |
PENG LIM ENTERPRISE CO., LTD. |
C.S. WANG |
K062650 |
09/21/2006 |
EP NAVIGATOR SOFTWARE |
PHILIPS MEDICAL SYSTEMS |
LYNN HARMER |
K061685 |
09/15/2006 |
PULSERA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
JOSEPH S ARNAUDO |
K061995 |
09/06/2006 |
XCELERA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
K062283 |
09/20/2006 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
ANDREAS SUCHI |
K062392 |
09/06/2006 |
PHILIPS MP5 INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
K061961 |
09/06/2006 |
ART LAB SOFTWARE |
PIE MEDICAL |
CARRI GRAHAM |
K062042 |
09/06/2006 |
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) |
PLETHORA SOLUTIONS |
KIMBERLEY DONEY |
K061564 |
09/01/2006 |
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD |
PORTLAND ORTHOPAEDICS PTY. LTD. |
ELAINE DUNCAN |
K062172 |
09/20/2006 |
FETCH ASPIRATION CATHETER |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
K061649 |
09/01/2006 |
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K062092 |
09/15/2006 |
PREVU POINT OF CARE SKIN STEROL TEST |
PREMD, INC. |
THOMAS M TSAKERIS |
K062160 |
09/12/2006 |
GO GO MINI, MODEL SC30 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
K061790 |
09/19/2006 |
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
PROTEIN POLYMER TECHNOLOGIES, INC. |
RADINE POBUDA |
K061008 |
09/08/2006 |
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 |
QUIDEL CORP. |
JOHN D TAMERIUS |
K060180 |
09/06/2006 |
BIOSET XC |
REGENERATION TECHNOLOGIES, INC. |
Lisa Simpson |
K061532 |
09/18/2006 |
GENTLE COLON (REVISION 2.0) |
RENDOSCOPY, INC. |
MIRA PATTANAYAK |
K062291 |
09/08/2006 |
VPAP MALIBU WITH H2I |
RESMED LTD. |
DAVID D'CRUZ |
K060919 |
09/22/2006 |
ACTICAL |
RESPIRONICS, INC. |
ZITA A YURKO |
K061785 |
09/07/2006 |
CYL-FIL OXYGEN SYSTEM |
RESPONSIVE RESPIRATORY INC. |
THOMAS BANNON |
K060948 |
09/05/2006 |
PORTRAIT PSR3 |
RHYTEC INCORPORATED |
MAUREEN O'CONNELL |
K062578 |
09/18/2006 |
DIGI-LITE TCD DEVICE |
RIMED LTD. |
AHAVA STEIN |
K061224 |
09/05/2006 |
LAPDOC I |
ROBODENT GMBH |
JUERGEN BIER |
K062319 |
09/13/2006 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K062239 |
09/11/2006 |
GLUCOSE HK NEW FORMULATION TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
K061780 |
09/15/2006 |
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + |
ROZINN ELECTRONICS, INC. |
MARK ROSOFF |
K061663 |
09/06/2006 |
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
MARC JAKER |
K062304 |
09/29/2006 |
DLM112 DAYLINK MONITOR |
RTX HEALTHCARE A/S |
BJARNE FLOU |
K062335 |
09/14/2006 |
SEDECAL X PLUS LP PLUS |
SEDECAL S.A. |
DANIEL KAMM |
K062342 |
09/25/2006 |
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT |
SENTRA MEDICAL DEVICES, LLC |
KARTHIK MARAYAN |
K062204 |
09/22/2006 |
ARCHITECT CORTISOL ASSAY |
SERADYN INC. |
EARL E KNIGHT |
K053254 |
09/19/2006 |
INFANT HEEL WARMER BY INTCO |
SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. |
JOHN ZHAO |
K062067 |
09/06/2006 |
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
K061442 |
09/05/2006 |
PULSE OXIMETER, MODEL PM-50 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K062655 |
09/18/2006 |
POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K062673 |
09/22/2006 |
MODIFICATION TO SYNGO INSPACE 4D |
SIEMENS AG, MEDICAL SOLUTIONS |
RUDIGER KOMER |
K061577 |
09/14/2006 |
OVALTWIST PEDICLE SCREW SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
MIKE ENSIGN |
K062506 |
09/08/2006 |
INCORIS AL |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K062509 |
09/12/2006 |
INCORIS ZI |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K062216 |
09/15/2006 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K062408 |
09/12/2006 |
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD |
SMITH & NEPHEW, INC. |
GINO ROUSS |
K062396 |
09/28/2006 |
MODIFICATION TO STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
K062095 |
09/29/2006 |
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
K062278 |
09/19/2006 |
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
K060012 |
09/29/2006 |
CLIRPATH TURBO PERIPHERAL CATHETERS |
SPECTRANETICS CORP. |
MICHAEL J RYAN |
K062071 |
09/28/2006 |
PROMETEY, MODEL G1-03 |
SPECTRUM INTERNATIONAL |
GEORGE I BEKOV |
K062468 |
09/13/2006 |
SPECTRUM M2 MONITOR |
SPECTRUM MEDICAL, LLP |
STEVE TURNER |
K060288 |
09/01/2006 |
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS |
SPIRE BIOMEDICAL, INC. |
Ray Kelly |
K060651 |
09/13/2006 |
PROXIS SYSTEM, MODEL EPS101 |
ST. JUDE MEDICAL |
KIMBERLY BRIGGS |
K060763 |
09/22/2006 |
STRYKER INJECTABLE CEMENT |
Stryker |
WADE T RUTKOSKIE |
K061225 |
09/14/2006 |
STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS |
STRYKER CORP. |
DESIREE MAE CRISOLO |
K061548 |
09/28/2006 |
STRYKER URETERAL ILLUMINATION SYSTEM IV |
STRYKER CORP. |
ERICA A WALTERS |
K061835 |
09/08/2006 |
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
K061813 |
09/19/2006 |
MANTIS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062701 |
09/25/2006 |
QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR |
SUNRISE MEDICAL, INC. |
JOSEPH E OLSAVSKY |
K062315 |
09/08/2006 |
SUPERDIMENSION/BRONCHUS PREMIUM 2 |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
K061910 |
09/21/2006 |
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K061973 |
09/11/2006 |
SYNTHES 3.5MM SPRING PLATE |
SYNTHES (USA) |
DEBORAH L JACKSON |
K061940 |
09/08/2006 |
SYNTHES LCP ANKLE ARTHRODESIS PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K053418 |
09/06/2006 |
SYNTHES OC FUSION SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
K062235 |
09/19/2006 |
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 |
K061662 |
09/15/2006 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K061659 |
09/15/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K062725 |
09/29/2006 |
MAXIFLEX-SEMI FLEX SCOPE |
TECHNOLOGY DELIVERY SYSTEMS, INC. |
CAROLANN KOTULA |
K062452 |
09/21/2006 |
KIT MENDEC SPINE AND DELIVERY SYSTEM |
TECRES SPA |
CHRISTINE BRAUER |
K062608 |
09/15/2006 |
29G AND 30G K-PACK II NEEDLE |
TERUMO EUROPE N.V. |
M.J. AERTS |
K061688 |
09/08/2006 |
ANTI-SNORING / SLEEP APNEA DEVICE |
TOMED DR. TOUSSAINT GMBH |
WINFRIED TOUSSAINT |
K061824 |
09/14/2006 |
TORNIER CEMENT RESTRICTOR |
TORNIER |
Mireille Lemery |
K061976 |
09/27/2006 |
CKIS-004A INJECTOR SYNCHRONIZATION OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K062022 |
09/11/2006 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062391 |
09/14/2006 |
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
K062428 |
09/29/2006 |
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS |
TRIPATH IMAGING, INC. |
BRYAN J TUCKER |
K062238 |
09/21/2006 |
TYTAN BLOOD PRESSURE CUFF |
TYTAN MEDICAL CORP. |
Ke-Min Jen |
K062326 |
09/01/2006 |
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
Daniel Campion |
K062618 |
09/22/2006 |
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K052523 |
09/07/2006 |
PROXIS SYSTEM |
VELOCIMED INC. |
KIMBERLY BRIGGS |
K062093 |
09/20/2006 |
AVEA VENTILATOR |
VIASYS RESPIRATORY CARE INC |
TOM GUTIERREZ |
K062062 |
09/11/2006 |
VOYAGER PACS SYSTEM |
VOYAGER IMAGING |
CARL ALLETTO |
K062425 |
09/15/2006 |
LIFECATH S PICC AND MIDLINE CATHETER |
VYGON CORP. |
COURTNEY SMITH |
K061250 |
09/29/2006 |
MULTICATH EXPERT |
VYGON CORP. |
COURTNEY SMITH |
K060944 |
09/15/2006 |
NUTRISAFE 2 |
VYGON CORP. |
COURTNEY SMITH |
K052475 |
09/14/2006 |
VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS |
VYGON US LLC |
COURTNEY SMITH |
K062693 |
09/29/2006 |
GLADIATOR BIPOLAR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K060953 |
09/18/2006 |
OCCULTECH FECAL OCCULT BLOOD RAPID TEST |
YD DIAGNOSTICS CORP. |
DUSIC KWAK |
K061410 |
09/08/2006 |
SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT |
ZIMMER DENTAL INC. |
Floyd Larson |
K061717 |
09/08/2006 |
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED |
ZIMMER DENTAL INC. |
ERIN MCVEY |
K062281 |
09/05/2006 |
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 |
ZIMMER DENTAL INC. |
ERIN L MCVEY |
K061155 |
09/22/2006 |
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM |
ZIMMER TRABECULAR |
ROBERT A POGGIE |
K061851 |
09/29/2006 |
ZIRKONZAHN ICE |
ZIRKONZAHN GMBH |
DONNA M HARTNETT |