| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K082670 |
09/15/2008 |
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET |
MEDTRONIC INC. |
BETH CLAAS |
| K082734 |
09/18/2008 |
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K082716 |
09/17/2008 |
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 |
A-DEC, INC. |
THOMAS H LOUISELL |
| K082827 |
09/25/2008 |
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT |
A-DEC, INC. |
THOMAS H LOUISELL |
| K082714 |
09/18/2008 |
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K082717 |
09/18/2008 |
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K082762 |
09/22/2008 |
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE |
AARDVARK MEDICAL |
|
| K082534 |
09/02/2008 |
ETEST VORICONAZOLE 0.002-32 UG/ML |
AB BIOMERIEUX |
ANETTE ENGELHARDT |
| K082668 |
09/18/2008 |
BIO-SCREEN |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K082887 |
09/30/2008 |
PM-1000F+PATIENT MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLIAN |
| K081433 |
09/03/2008 |
EK/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K082612 |
09/09/2008 |
GBS PNA FISH |
ADVANDX, INC. |
PAULA E BULGER |
| K082529 |
09/04/2008 |
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM |
ALATECH HEALTHCARE, LLC. |
NEIL ANDERSON |
| K082858 |
09/29/2008 |
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER |
ALCAVIS INTERNATIONAL, INC. |
GARY J MISHKIN |
| K082845 |
09/26/2008 |
INFINITI VISION SYSTEM WITH OZIL IP |
ALCON RESEARCH, LTD. |
MICHAEL BUENGER |
| K082622 |
09/09/2008 |
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE |
ALMA LASERS LTD. |
ANNE WORDEN |
| K082857 |
09/29/2008 |
RENEGADE WHEELCHAIR |
ALPHA ONE |
PATSY J TRISLER |
| K082898 |
09/30/2008 |
AMEDICA DRUG SCREEN TEST CUP |
AMEDICA BIOTECH, INC. |
JEFF CHEN |
| K082677 |
09/15/2008 |
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K082730 |
09/30/2008 |
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K082729 |
09/18/2008 |
RIMCLOSE BONE ANCHOR |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K082575 |
09/05/2008 |
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES |
APATECH LTD. |
CANDACE F CEDERMAN |
| K082846 |
09/29/2008 |
APK SPO2 PULSE OXIMETER SENSOR |
APK TECHNOLOGY CO., LTD |
DIANA HONG |
| K082504 |
09/02/2008 |
APOLLO ANTERIOR CERVICAL PLATE SYSTEM |
APOLLO SPINE, INC. |
PAMELA PAPINEAU, RAC |
| K082562 |
09/04/2008 |
APPLIED BIOSYSTEMS 7500 FAST DX |
APPLIED BIOSYSTEMS INC |
JOHN D'ANGELO |
| K082839 |
09/26/2008 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
BRYAN BABB |
| K082810 |
09/24/2008 |
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW |
ARTHREX, INC. |
NANCY HOFT |
| K082666 |
09/12/2008 |
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K082515 |
09/03/2008 |
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX |
ASAHI KASEI MEDICAL CO., LTD. |
DAVID L WEST |
| K082910 |
09/30/2008 |
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, "XYZ" SILVER BANDAGES |
ASO LLC |
JONATHAN WARD |
| K082748 |
09/30/2008 |
ATRIUM PROLITE S MESH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K082869 |
09/29/2008 |
AWBAT-S, AWBAT-D, AWBAT-M |
AUBREY, INC. |
STEPHEN MOSS |
| K082704 |
09/16/2008 |
BIRTHTRACK (A.K.A. CLM) |
BARNEV, LTD. |
AHAVA STEIN |
| K082589 |
09/08/2008 |
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 |
BAROSENSE, INC |
DANIEL J BALBIERZ |
| K082749 |
09/19/2008 |
OMNI-TIGHT |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
| K082913 |
09/30/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K082852 |
09/29/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
| K082538 |
09/02/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K082787 |
09/23/2008 |
VITAL SIGNS MONITOR, MODEL: MD500B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
DIANA HONG |
| K082826 |
09/25/2008 |
VANGUARD CR STEM HOUSINGS |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
| K082793 |
09/29/2008 |
INTERGRO DBM |
BIOMET SPINE |
KATHLEEN IDEO |
| K082757 |
09/19/2008 |
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
| K082705 |
09/16/2008 |
BIOPRO BIPOLAR HEAD, MODELS 18130-18152 |
BIOPRO, INC. |
DAVID MRAK |
| K082449 |
09/05/2008 |
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
BISCO, INC. |
MICHELLE SCHILTZ-TAING |
| K082652 |
09/17/2008 |
BITTAR ZIRCONIA BLOCKS |
BITTAR ZIRCONIA BLOCK, LLC |
STUART R GOLDMAN |
| K082797 |
09/23/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K082841 |
09/26/2008 |
SPINAL FORAMINOSCOPE |
BLAZEJEWSKI MEDI-TECH GMBH |
ANGELIKA SCHERP |
| K082906 |
09/30/2008 |
UNITY BETA ANCHOR SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK G BALSMANN |
| K082568 |
09/04/2008 |
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K082345 |
09/04/2008 |
OXYGEN DEMAND VALVE |
BPR MEDICAL, LTD. |
BEN JOHNSON |
| K082886 |
09/30/2008 |
ZOOM-100DC |
BRAINSCOPE COMPANY, INC. |
MICHAEL E SINGER |
| K082508 |
09/02/2008 |
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K082582 |
09/08/2008 |
SENTINEL, MODEL SP-001 |
C-RAD POSITIONING AB |
CRISTINA SVENSSON |
| K082571 |
09/05/2008 |
AVAULTA SUPPORT SYSTEM |
C.R. BARD, INC. |
JOHN C KNORPP |
| K082687 |
09/15/2008 |
COLLAMEND FM IMPLANT |
C.R. BARD, INC. |
KEVIN G STEVENS |
| K082681 |
09/15/2008 |
VACORA VACUUM ASSISTED BIOPSY SYSTEM |
C.R. BARD, INC. |
CINDY MOSS |
| K082693 |
09/15/2008 |
RESOLUTIONMD, RELEASE 2.1 |
CALGARY SCIENTIFIC, INC. |
PIERRE LEMIRE |
| K082521 |
09/02/2008 |
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K082542 |
09/03/2008 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A |
CARDICARE COMPANY, LTD. |
|
| K082539 |
09/03/2008 |
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT |
CARDINAL HEALTH GERMANY 234 GMBH |
THOMAS RUST |
| K082829 |
09/25/2008 |
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) |
CARLETON LIFE SUPPORT SYSTEMS INC. |
GARY BYRD |
| K082518 |
09/02/2008 |
DUAL NEEDLE SUTURE PASSER SYSTEM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K082629 |
09/09/2008 |
S12X WITH ESAX OPTION |
CHATTEN ASSOCIATES, INC. |
JOHN B CHATTEN |
| K082628 |
09/09/2008 |
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 |
CIRCLE CARDIOVASCULAR IMAGING INC. |
SHIRANTHA SAMARAPPULI |
| K082134 |
09/11/2008 |
CIRCULATOR BOOT |
CIRCULATOR BOOT CORP. |
RICHARD S DILLON |
| K082556 |
09/09/2008 |
CLEARCORRECT |
CLEARCORRECT, INC. |
WILLIAM GREENROSE |
| K082599 |
09/08/2008 |
NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT |
CNSYSTEM MEDIZINTECHNIK AG |
SUMPER |
| K082640 |
09/10/2008 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM |
COLOPLAST MANUFACTURING US, LLC |
ANGELA BYLAND |
| K082641 |
09/11/2008 |
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
CONTEC MEDICAL SYSTEM CO., LTD. |
DIANA HONG |
| K082682 |
09/15/2008 |
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG |
COOK BIOTECH, INC. |
DANIEL J DILLON |
| K082536 |
09/02/2008 |
COOK WIRE GUIDES |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K082525 |
09/02/2008 |
CORIN METAFIX FEMORAL STEM |
CORIN USA |
ASHLEA BOWEN |
| K082659 |
09/12/2008 |
MODIFIED ENDO STICH |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K082619 |
09/09/2008 |
SILS PORT, MODELS SILSPT5, SILSPT12 |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K082849 |
09/29/2008 |
SILENT SLEEP |
CRANIOFACIAL PAIN CENTER OF IDAHO |
JAMISON R SPENCER |
| K082606 |
09/08/2008 |
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) |
D3 RADIATION PLANNING |
NABIL ADNANI |
| K082731 |
09/18/2008 |
ML24000 UVA-1 PHOTOTHERAPY CABINET |
DAAVLIN DISTRIBUTING CO. |
TARA MANSUR |
| K082784 |
09/23/2008 |
JUMAO MANUAL WHEELCHAIR |
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. |
QING WANG |
| K082843 |
09/30/2008 |
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM |
DENTIS CO. LTD. |
JUNG BAE BANG |
| K082643 |
09/30/2008 |
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
| K082585 |
09/08/2008 |
DEPUY ASPHERE M-SPEC HEAD |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K082715 |
09/17/2008 |
DEPUY GLOBAL AP CTA HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K082675 |
09/15/2008 |
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K082462 |
09/09/2008 |
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ |
DIAMOND DIAGNOSTICS, INC. |
LIANN VOO |
| K082763 |
09/22/2008 |
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K082904 |
09/30/2008 |
STASYS MOTION CORRECTION SOFTWARE |
DIGIRAD CORP. |
JOEL TUCKEY |
| K082588 |
09/08/2008 |
GAMMALOC SYSTEM, MODEL 03-00001 |
DILON TECHNOLOGIES LLC |
ELAINE DUNCAN |
| K082600 |
09/10/2008 |
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) |
DRAEGER MEDICAL B.V. |
JOYCE KILROY |
| K082888 |
09/30/2008 |
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 |
DRAEGER MEDICAL SYSTEMS, INC. |
PRADEEP GUPTA |
| K082261 |
09/23/2008 |
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
DXRAD SOLUTIONS LTD. |
DANIEL KAMM |
| K082899 |
09/30/2008 |
DYNAMIPEAK PEAK FLOW METER |
DYNAMITECH MEDICAL, INC |
KEITH LOWREY |
| K082863 |
09/29/2008 |
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) |
DYNAREX CORPORATION |
JAMES HURLMAN |
| K082791 |
09/23/2008 |
EMS AIR-FLOW MASTER |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA J NOLTE |
| K082465 |
09/15/2008 |
EVERON |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K082602 |
09/08/2008 |
FETAL & MATERNAL MONITOR, MODEL F6, F9 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K082663 |
09/12/2008 |
COLOR LCD MONITOR |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K082834 |
09/26/2008 |
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC |
ELLMAN INT'L INC. |
RICK EPSTEIN |
| K082601 |
09/08/2008 |
INSTA-CLOT, INSTA-CLOT OTC |
EMERGENCY MEDICAL DEVICES, LLC |
JACK MENTKOW |
| K082844 |
09/26/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K082409 |
09/08/2008 |
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 |
ENDOPHOTONIX, INC |
KIRK S HONOUR |
| K082825 |
09/25/2008 |
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM |
ENERGIST, LTD. |
TIM MAJOR |
| K082569 |
09/05/2008 |
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE |
ENTELLUS MEDICAL, INC. |
SEW-WAH TAY |
| K082750 |
09/19/2008 |
ENTACT SEPTAL STAPLER, MODEL 610-00100 |
ENTRIGUE SURGICAL, INC. |
GABRIELE G NIEDERAUER |
| K082655 |
09/12/2008 |
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K082609 |
09/08/2008 |
ERCHONIA ML SCANNER (MLS) |
ERCHONIA MEDICAL |
KEVIN WALLS |
| K082893 |
09/30/2008 |
PRAGER SHELL |
ESI, INC. |
GEORGE MYERS |
| K082579 |
09/05/2008 |
EVERCROSS .035 OTW PTA DILATATION CATHETER |
EV3 INC. |
DAVID WORRELL |
| K082854 |
09/29/2008 |
NANOCORSS .014 OTW PTA DILATATION CATHETER |
EV3 INC. |
DAVID WORRELL |
| K082702 |
09/16/2008 |
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY |
EXACTECH, INC. |
SHING JEN TAI |
| K082875 |
09/29/2008 |
PORTABLE X-RAY SYSTEM, MODEL DXR -1 |
EXARO CO., LTD. |
SHIN KUK YOO |
| K082837 |
09/26/2008 |
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
EXCELSIOR MEDICAL CORP. |
JOHN LINFANTE |
| K082656 |
09/12/2008 |
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT |
FUKUDA DENSHI USA, INC. |
LORAN VAN NOY |
| K082768 |
09/23/2008 |
G-BOND PLUS |
GC AMERICA, INC. |
MARK HEISS |
| K082740 |
09/22/2008 |
GC AADVA ZR DISK |
GC AMERICA, INC. |
MARK HEISS |
| K082540 |
09/02/2008 |
GE ENTROPY SENSOR |
GE HEALTHCARE |
JOEL C KENT |
| K082781 |
09/22/2008 |
OEC 9900 ELITE |
GE HEALTHCARE SURGERY |
MARIA C FRAME |
| K082851 |
09/29/2008 |
MULTLINK CABLE AND LEADWIRE SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MATTHIAS BUERGER |
| K082816 |
09/25/2008 |
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
STEVEN KACHELMEYER |
| K082761 |
09/22/2008 |
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
TRACEY ORTIZ |
| K082676 |
09/15/2008 |
GENADYNE A4 WOUND VACUUM SYSTEM |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN-MING GOH |
| K082789 |
09/24/2008 |
G1B PULSE OXIMETER |
GENERAL MEDITECH, INC. |
DIANA HONG |
| K081640 |
09/30/2008 |
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS |
GIMMI GMBH |
KEN BLAKE |
| K082865 |
09/30/2008 |
MODIFICATION TO ZENIEVA |
GORBEC PHARMACEUTICAL SERVICES, INC. |
SANDRA R KIRCUS |
| K082286 |
09/03/2008 |
BIOACTYS |
GRAFTYS |
ANTHONY LE NAOUR |
| K082498 |
09/03/2008 |
GRAFTYS HBS |
GRAFTYS |
ANTHONY LE NAOUR |
| K082723 |
09/17/2008 |
GRINDGUARD |
GRIND GUARD TECHNOLOGIES, LLC |
BILL MCLAIN |
| K082891 |
09/30/2008 |
LENSTAR, MODEL LS900 |
HAAG-STREIT AG |
LENA SATTLER |
| K082616 |
09/09/2008 |
HASELMEIER PEN 8 |
HASELMEIER GMBH |
STEPHEN J GOLDNER |
| K082591 |
09/08/2008 |
FLEXITIME BITE |
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
CHERYL V ZIMMERMAN |
| K082892 |
09/30/2008 |
REJUVENATE MONOLITHIC HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
DENISE DAUGERT |
| K082567 |
09/04/2008 |
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K082883 |
09/29/2008 |
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082880 |
09/29/2008 |
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082879 |
09/29/2008 |
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082806 |
09/24/2008 |
SPINNING SPIROS, MODEL CH-2000 |
ICU MEDICAL, INC |
TRACY BEST |
| K082836 |
09/26/2008 |
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES |
ICU MEDICAL, INC. |
NILOUFAR SAMIMI |
| K082706 |
09/16/2008 |
INFINITT CARDIOLOGY PACS |
INFINITT CO., LTD. |
CARL ALLETTO |
| K082746 |
09/19/2008 |
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 |
INSIGHTRA MEDICAL, INC. |
TOM COLONNA |
| K082853 |
09/29/2008 |
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR |
INSPIRED TECHNOLOGIES, INC. |
PAUL DRYDEN |
| K082545 |
09/03/2008 |
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K082764 |
09/22/2008 |
STRAUMANN WN CARES TITANIUM ABUTMENT |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K082859 |
09/29/2008 |
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K082795 |
09/25/2008 |
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT |
INTERVENTIONAL SPINE, INC. |
CAROL EMERSON |
| K082916 |
09/30/2008 |
HRB-127-32 HIGH RESOLUTION BRAIN COIL |
INVIVO |
JEFF WILKINSON |
| K082416 |
09/03/2008 |
IBA PROTON THERAPY SYSTEM- PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN REISS |
| K082530 |
09/02/2008 |
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY |
ISODOSE CONTROL B.V. |
HUB VAN DE BERGH |
| K082808 |
09/24/2008 |
IMAGESVR PACS |
JAGUAR TECHNOLOGY LIMITED |
KE-MIN JEN |
| K082911 |
09/30/2008 |
SMOOTHCOOL HR SYSTEM |
JEISYS MEDICAL, INC. |
KEVIN WALLS |
| K082882 |
09/30/2008 |
A.V. FISTULA BLUNT NEEDLE SET |
JMS NORTH AMERICA CORP. |
MARIA F GRIFFIN |
| K082698 |
09/17/2008 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
RICHARD WOODS |
| K082769 |
09/23/2008 |
MESA AND RANGE SPINAL SYSTEMS |
K2M, INC. |
RICHARD W WOODS |
| K082560 |
09/04/2008 |
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT |
KETTENBACH GMBH & CO KG |
MICHAELA ZINKE |
| K082824 |
09/25/2008 |
FLUID FILLED TEETHER |
KIDS II |
BILL YUNG |
| K082554 |
09/03/2008 |
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
| K082509 |
09/04/2008 |
EOS SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
JUNG BAE BANG |
| K082399 |
09/04/2008 |
PECTUS STRUT |
KOROS USA, INC. |
TIBOR KOROS |
| K082767 |
09/22/2008 |
KOWA NONMYD ALPHA-DIII |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K082900 |
09/30/2008 |
KYMCO FORU, MODEL EQ10 |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K082901 |
09/30/2008 |
KYMCO FORU, MODEL EQ20 |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K082752 |
09/19/2008 |
QUICKPIN |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K082614 |
09/09/2008 |
EVOX ELECTRO DIAGNOSTIC DEVICE |
LABORIE MEDICAL TECHNOLOGIES, INC. |
BARBARA MORNET |
| K082774 |
09/22/2008 |
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
LANX, LLC |
ALAN BURKHOLDER |
| K082685 |
09/15/2008 |
GALAXY 55 |
LARSEN & TOUBRO LIMITED |
S.B. BHOSALE |
| K082592 |
09/08/2008 |
LDR SPINE EASYSPINE SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K082802 |
09/24/2008 |
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B |
LEARNING CURVE BRANDS INC. THE FIRST YEARS |
SUPRAVAN KHONGKRUAPHAN |
| K082367 |
09/12/2008 |
INFANT SLEEP BEANIE |
LIFE INNOVATIONS LLC |
JANE SCOTT |
| K082772 |
09/22/2008 |
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 |
LIFE-TECH, INC. |
JEFF KASOFF |
| K082513 |
09/02/2008 |
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
OYINKAN DONALDSON |
| K082590 |
09/08/2008 |
SYMPHONY METER REMOTE |
LIFESCAN, INC. |
MARTHA MURARI |
| K082586 |
09/08/2008 |
LIGHTWAVE PROFESSIONAL DELUXE |
LIGHTWAVE TECHNOLOGIES LLC |
MARIA F GRIFFIN |
| K082809 |
09/24/2008 |
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
LUMENIS, INC. |
FRANCES E HARRISON |
| K082700 |
09/15/2008 |
TEMPORARY COLD.V AND SELF-CURE DENTINE |
MAJOR PRODOTTI DENTARI S.P.A. |
MONICA FUNAI |
| K082520 |
09/02/2008 |
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES |
MALLINCKRODT MEDICAL |
SCOTT D DICKERHOFF |
| K082544 |
09/03/2008 |
QUART ARTERIAL FILTER WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K082725 |
09/25/2008 |
GRAFTGUARD PRESSURE CONTROLLING SYRINGE |
MAQUET CARDIOVASCULAR, LLC |
CHRISTINA L ROWE |
| K082818 |
09/30/2008 |
SUBCUTANEOUS NEEDLE INFUSION SET |
MARCAL MEDICAL, INC. |
ARTHUR WARD |
| K082703 |
09/16/2008 |
MRDH BANDAGE |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K082856 |
09/29/2008 |
CARAPASTE ORAL WOUND DRESSING |
MCGRATH PHARMACEUTICALS, INC. |
PATRICK D MCGRATH |
| K082792 |
09/23/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K082541 |
09/02/2008 |
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM |
MEDI NUCLEAR CORP., INC. |
JERRY SCHOEN |
| K082587 |
09/08/2008 |
AUTO-SAFETY INJECTOR-2 (ASI-2) |
MEDICAL HOUSE PRODUCTS LIMITED |
ROSE Y GUANG |
| K082472 |
09/05/2008 |
VIROCULT, MODEL MW950 |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K082577 |
09/05/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J D WEBB |
| K082514 |
09/02/2008 |
TENS/EMS COMBO, EMS, TENS |
MEDIHIGHTEC MEDICAL CO., LTD. |
MU-SHENG HUNG |
| K082657 |
09/12/2008 |
RTX RESPIRATOR |
MEDIVENT LIMITED |
SHAHAR HAYEK |
| K082905 |
09/30/2008 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC |
MEDRAD, INC. |
FORTUNATO ALDAPE |
| K082917 |
09/30/2008 |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K082918 |
09/30/2008 |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K082732 |
09/18/2008 |
MODIFICATION TO: CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K082728 |
09/18/2008 |
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MELISA LANSKY |
| K082873 |
09/29/2008 |
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES |
MEDTRONIC VASCULAR |
TARA N TURNEY |
| K082707 |
09/16/2008 |
MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K082581 |
09/05/2008 |
C-QUEST |
MEDX, INC. |
WILLIAM GREENROSE |
| K082855 |
09/29/2008 |
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K082613 |
09/08/2008 |
MERIT MICROCATHETER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K082881 |
09/29/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K082357 |
09/04/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K082461 |
09/04/2008 |
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K082739 |
09/18/2008 |
MICRUS MICROCOIL DELIVERY SYSTEM |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K082627 |
09/13/2008 |
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL |
MINXRAY, INC. |
DANIEL KAMM |
| K082766 |
09/22/2008 |
MODIFICATION TO MINISPIR, SPIROLAB III |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K082819 |
09/25/2008 |
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 |
MIRAMAR LABS, INC. |
KATHY O'SHAUGHNESSY |
| K082710 |
09/16/2008 |
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET |
NEOCHILD, LLC |
RHETT BOLEN |
| K082724 |
09/17/2008 |
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM |
NEWPORT MEDICAL INSTRUMENTS, INC. |
DIANA RODRIGUEZ |
| K082566 |
09/04/2008 |
MARK 5 NUVO LITE OCSI AND STD |
NIDEK MEDICAL PRODUCTS, INC. |
JENNIFER MCWILLIAMS |
| K082785 |
09/23/2008 |
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K082719 |
09/17/2008 |
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P |
NIKKISO CO. LTD. |
FUMIAKI KANAI |
| K082528 |
09/02/2008 |
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM |
NOBLE ANESTHESIA-AIR, INC. |
ALEXANDER B HENDERSON |
| K082672 |
09/16/2008 |
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
NOVABONE PRODUCTS, LLC |
DAVID M GALSSER |
| K082642 |
09/11/2008 |
ONCENTRA RT VIEWER 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K082524 |
09/03/2008 |
MINI GHOST, MODEL: 507 |
NUMED, INC. |
NICHELLE LAFLESH |
| K082868 |
09/29/2008 |
MULLINS-X, MODEL 250X |
NUMED, INC. |
NICHELLE LAFLESH |
| K082776 |
09/22/2008 |
NUCLEUS-X PTV CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K082833 |
09/30/2008 |
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER |
NUTEK ORTHOPAEDICS, INC. |
PETER MINCIELLI |
| K082720 |
09/23/2008 |
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K082576 |
09/09/2008 |
XCHF-T160 VIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K082812 |
09/24/2008 |
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K082574 |
09/05/2008 |
MAXTORQUE MINI CANNULATED SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K082838 |
09/30/2008 |
ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN CAMBRIA |
| K082523 |
09/02/2008 |
OSSTELL ISQ IMPLANT STABILITY METER |
OSSTELL AB |
CHERITA JAMES |
| K082213 |
09/04/2008 |
GS III FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K082615 |
09/09/2008 |
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES |
OSTEOTECH INC |
CHRIS TALBOT |
| K082722 |
09/17/2008 |
P & F POWER WHEELCHAIR, MODEL HC-500SB |
P&F BROTHER IND.,CORP |
KE-MIN JEN |
| K082799 |
09/23/2008 |
HDS HI 1.54 |
PARAGON VISION SCIENCES |
WILLIAM MEYERS |
| K082800 |
09/24/2008 |
STAR/VENT INTERNAL HEX SCREW IMPLANT |
PARK DENTAL RESEARCH CORP. |
DANIEL J MANELLI |
| K082664 |
09/12/2008 |
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
KEN PERINO |
| K082786 |
09/23/2008 |
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES |
PEAK SURGICAL, INC. |
GRACE CARLSON |
| K082803 |
09/24/2008 |
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
| K082759 |
09/22/2008 |
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
PHADIA US INC. |
MARTIN R MANN |
| K082583 |
09/08/2008 |
INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HERBERT VAN DYK |
| K082633 |
09/10/2008 |
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K082721 |
09/17/2008 |
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS |
PHOTOMEDEX, INC. |
ALFRED INTINTOLI |
| K082301 |
09/18/2008 |
GRIND NO MORE |
PLACONTROL INC. |
JONATHAN S KAHAN |
| K082330 |
09/13/2008 |
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
PRIMARY CARE SOLUTIONS, INC. |
RON MADDIX |
| K082817 |
09/25/2008 |
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M |
PRIMUS STERILIZER COMPANY, LLC. |
LYLE LOHRMEYER |
| K082661 |
09/12/2008 |
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K082688 |
09/15/2008 |
PRO HMPV+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K082850 |
09/29/2008 |
EYE SPHERES |
PRODUCT AND EDUCATIONAL SERVICES LLC |
EDWARD GRIFFITH |
| K082620 |
09/09/2008 |
ONCE-A-DAY VERTOS TEST PACK |
PROPPER MFG. CO., INC. |
MARIAN M SCHUMAN |
| K082771 |
09/22/2008 |
PROTRON TECHNOLOGIES, LLC "STETHOTRON" |
PROTRON TECHNOLOGIES, LLC |
LEON M DONDYSH |
| K082302 |
09/30/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K082805 |
09/24/2008 |
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX |
Q UROLOGICAL CORPORATION |
SCOTT M EPSTEIN |
| K082636 |
09/10/2008 |
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T |
QUALITY ELECTRODYNAMICS |
|
| K082631 |
09/10/2008 |
THROMBO TEK PSE, MODEL 90-480 |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K082756 |
09/19/2008 |
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K082594 |
09/08/2008 |
REMESENSE |
REMEDENT NV |
WILLIAM GREENROSE |
| K082603 |
09/10/2008 |
TRIMIRA OCS 3000 |
REMICALM, LLC |
DAVID B JONES |
| K082718 |
09/17/2008 |
TEMPUSIC PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K082782 |
09/22/2008 |
REPLICATION MEDICAL VESSEL GUARD |
REPLICATION MEDICAL INC |
MARCOS VELEZ-DURAN |
| K082605 |
09/25/2008 |
VPAP AUTO WITH HUMIDAIRE 3I |
RESMED LTD. |
DAVID D'CRUZ |
| K082660 |
09/12/2008 |
V60 VENTILATOR, MODEL V8000 |
RESPIRONICS CALIFORNIA, INC. |
MARA CALER |
| K082866 |
09/29/2008 |
REVOLUTIONFULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW ZELTWANGER |
| K082558 |
09/09/2008 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
ANDREW ZELTWANGER |
| K082654 |
09/12/2008 |
ENTERAL ONLY EXTENSION SET |
RESPIRONICS, INC. |
ANDREW P ZELTWANGER |
| K082553 |
09/03/2008 |
REXASTOM ORAL EASE |
REXADERM, INC. |
CLYDE R GOODHEART |
| K082699 |
09/15/2008 |
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS |
ROCHE DIAGNOSTICS |
JANE PHILLIPS |
| K082595 |
09/11/2008 |
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
ROCHE DIAGNOSTICS |
SCOTT THIEL |
| K082902 |
09/30/2008 |
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES |
RZ MEDIZINTECHNIK GMBH |
ANGELIKA SCHERP |
| K082573 |
09/05/2008 |
SARGON NON-EXPANDABLE DENTAL IMPLANT |
SARGON ENT., INC. |
DANIEL J MANELLI |
| K082755 |
09/19/2008 |
SEDAT FLAMINGO |
SEDAT |
CHARLES COUSIN |
| K082876 |
09/29/2008 |
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY |
SHARPLIGHT TECHNOLOGIES LTD. |
ILAN SHARON |
| K082224 |
09/22/2008 |
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K082744 |
09/18/2008 |
BEAUTIBOND |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K082735 |
09/18/2008 |
STONE GRASPING BASKET, MODEL PD-T1 2115 |
SIALO TECHNOLOGY, LTD. |
AHAVA STEIN |
| K082645 |
09/11/2008 |
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K082680 |
09/15/2008 |
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K082638 |
09/10/2008 |
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
YUK-TING LEWIS |
| K082775 |
09/22/2008 |
PRESCISION OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K082848 |
09/29/2008 |
NUBIC AND RABEA DEVICES |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K082679 |
09/18/2008 |
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X |
SINTEA BIOTECH, INC. |
DANIELLE WERNIKOWSKI |
| K082871 |
09/29/2008 |
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM |
SIS LTD. SURGICAL INSTRUMENT SYSTEMS |
KEVIN WALLS |
| K082516 |
09/02/2008 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS |
SMITH & NEPHEW, INC. |
LAURA SEJNOWSKI |
| K082783 |
09/23/2008 |
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K082543 |
09/03/2008 |
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 |
SONOCINE, INC. |
ROBERT J CHIN |
| K082796 |
09/30/2008 |
SOPRO 184 CAMERA |
SOPRO |
RICK ROSATI |
| K082651 |
09/12/2008 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
| K082580 |
09/09/2008 |
SPECTRA GUIDEWIRE INTRODUCER NEEDLE |
SPECTRA MEDICAL DEVICES, INC. |
AGUSTIN TURRIZA |
| K082674 |
09/15/2008 |
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE |
SPECTRA MEDICAL DEVICES, INC. |
SCOTT HENDERSON |
| K082689 |
09/15/2008 |
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
DAVID L ROSEN |
| K082559 |
09/08/2008 |
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K082561 |
09/08/2008 |
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K082821 |
09/25/2008 |
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K082683 |
09/15/2008 |
SD CHECK GOLD |
STANDARD DIAGNOSTICS, INC. |
WILLIAM GREENROSE |
| K082773 |
09/22/2008 |
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K082765 |
09/22/2008 |
ASTOFLO PLUS |
STIHLER ELECTRONIC GMBH |
STEPHEN T MLCOCH |
| K082758 |
09/19/2008 |
PRISMAFLO II |
STIHLER ELECTRONIC GMBH |
STEPHEN T MLCOCH |
| K082532 |
09/02/2008 |
STRAUMANN GUIDED INSTRUMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K082813 |
09/24/2008 |
STRYKER LED LIGHTSOURCE |
STRYKER CORP. |
DESIREE CRISOLO |
| K082608 |
09/08/2008 |
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 |
STRYKER SPINE |
CURTIS TRUESDALE |
| K082535 |
09/02/2008 |
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
TIM M LOHNES |
| K082662 |
09/12/2008 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
RENEE BORGESANO |
| K082828 |
09/25/2008 |
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE |
SUTURTEK INCORPORATED |
ART RANKIS |
| K082671 |
09/15/2008 |
HERCULITE ULTRA |
SYBRON DENTAL SPECIALTIES |
WENDY GARMAN |
| K082807 |
09/24/2008 |
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS |
SYNTHES (USA) |
JILL R SHERMAN |
| K082625 |
09/09/2008 |
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K082624 |
09/09/2008 |
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K082649 |
09/12/2008 |
SYNTHES 90 DEGREE SCREWDRIVER |
SYNTHES (USA) |
ANDREA M TASKER |
| K082650 |
09/12/2008 |
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
SYNTHES (USA) |
JILL R SHERMAN |
| K082914 |
09/30/2008 |
CLAMPFIX |
SYNTHES SPINE |
JASON LIPMAN |
| K082572 |
09/09/2008 |
USS ILIOSACRAL, USS POLYAXIAL |
SYNTHES SPINE |
JASON LIPMAN |
| K082618 |
09/09/2008 |
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 |
TAIDOC TECHNOLOGY CORPORATION |
YUHUA CHEN |
| K082597 |
09/08/2008 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K082598 |
09/08/2008 |
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE |
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. |
CHU XIAOAN |
| K082623 |
09/23/2008 |
VISIX IMAGING |
TELEVERE SYSTEMS |
BARBARA DEAY |
| K082820 |
09/25/2008 |
K-PACK II NEEDLE - 29G THIN WALL |
TERUMO EUROPE N.V. |
M J AERTS |
| K082519 |
09/02/2008 |
FINECROSS MG CORONARY MICRO-GUIDE CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K082644 |
09/11/2008 |
GLIDESHEATH |
TERUMO MEDICAL CORP. |
|
| K082847 |
09/29/2008 |
PINNACLE ROII INTRODUCER SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K082736 |
09/18/2008 |
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K082637 |
09/10/2008 |
CRANIAL PERFORATOR |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
| K082823 |
09/25/2008 |
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS |
THE BINDING SITE GROUP LTD |
JAY H GELLER |
| K082909 |
09/30/2008 |
RSVP HALF SPHERE PHANTOM, MODEL DDP010 |
THE PHANTOM LABORATORY, INC. |
JOSHUA R LEVY |
| K082712 |
09/16/2008 |
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K082754 |
09/19/2008 |
AEQUALIS HUMERAL NAIL SYSTEM |
TORNIER |
BRIAN HODOREK |
| K082684 |
09/15/2008 |
4D VIEWER RADIOLOGY, MODEL USWP-100A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082830 |
09/26/2008 |
INFX-8000H, INFINIX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
| K082596 |
09/08/2008 |
ULTRAEXTEND USWS-900A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082617 |
09/09/2008 |
TRAUSON GENERAL SPINAL SYSTEM (GSS) |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
DIANA HONG |
| K082584 |
09/09/2008 |
GIVEN ELECTROSURGICAL NEEDLE |
TRIPPS COURT ENTERPRISES, INC |
JULIE STEPHENS |
| K082919 |
09/30/2008 |
UC-CARE POSITIONING SYSTEM |
UC-CARE MEDICAL SYSTEMS LTD |
JONATHAN S KAHAN |
| K082546 |
09/03/2008 |
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) |
UNIMED MEDICAL SUPPLIES INC. |
DON MELNIKOFF |
| K082686 |
09/15/2008 |
MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
DAVID O CHANG |
| K082811 |
09/24/2008 |
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS |
URIT MEDICAL ELECTRONIC CO., LTD. |
MARIA GRIFFIN |
| K082701 |
09/16/2008 |
URONIRS, MODEL 2000 |
URODYNAMIX TECHNOLOGIES LTD |
ANDRE KINDSVATER |
| K082801 |
09/24/2008 |
PHANTOM PLUS CAGE SYSTEM |
US SPINE |
PETER HARRIS |
| K082646 |
09/11/2008 |
OPTIMUS 0.035" PTA BALLOON DILATATION CATHETER |
USCI IRELAND |
MAUREEN O'CONNELL |
| K082653 |
09/12/2008 |
CENTERING INTRALUMINAL APPLICATOR |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K082870 |
09/30/2008 |
VTI INTRAOPERATIVE DOPPLER SYSTEMS |
VASCULAR TECHNOLOGY INCORPORATED |
DAVID L REGAN |
| K082634 |
09/10/2008 |
VERTIGONE BPPV GOGGLE |
VERTIGONE, INC. |
JAYE THOMPSON |
| K082709 |
09/16/2008 |
VICOR PD2I ANALYZER, VERSION 2.1 |
VICOR TECHNOLOGIES, INC. |
JULES MITCHEL |
| K082329 |
09/22/2008 |
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K082667 |
09/12/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K082727 |
09/18/2008 |
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K082604 |
09/11/2008 |
VIZTEK DR, MODELS: DR1000, DR3000, DR4000 |
VIZTEK, INC. |
DANIEL KAMM |
| K082753 |
09/19/2008 |
FUTURABOND M/FUTURABOND M SINGLE DOSE |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K082607 |
09/08/2008 |
MRI-PLAQUE VIEW, VERSION 1.1.2003 |
VPDIAGNOSTICS, INC |
MICHAEL HARTMANN |
| K082478 |
09/02/2008 |
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K082815 |
09/25/2008 |
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS |
WELL LEAD MEDICAL INSTRUMENTS |
HAN GUANG YUAN |
| K082626 |
09/09/2008 |
PAM 3000 |
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
EFRAIM GAVRILOVICH |
| K082673 |
09/15/2008 |
CONSERVE PRESSFIT FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K082630 |
09/10/2008 |
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES |
ZEFON INTL. |
SCOTT RYAN |
| K082822 |
09/25/2008 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO ZHUANGYUAN PLASTIC PRODUCTS COMPANY |
CHU XIAOAN |
| K082639 |
09/23/2008 |
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K082770 |
09/22/2008 |
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K082527 |
09/02/2008 |
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
