| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K091059 |
08/13/2009 |
FOXQ 980 LASER |
A.R.C. LASER GMBH |
KIRSTEN PAULSON |
| K083250 |
08/18/2009 |
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS |
AA NEUROMED CORP. |
HERMANN DOLKER |
| K090358 |
08/06/2009 |
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 |
ABBOTT LABORATORIES INC |
JUDI WALLACH |
| K092286 |
08/27/2009 |
FOX SV PTA CATHETER |
Abbott Vascular |
NADINE SMITH |
| K091827 |
08/18/2009 |
S. AUREUS PNA FISH |
ADVANDX, INC. |
PAULA E BURGER |
| K092238 |
08/11/2009 |
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS |
AGFA HEALTHCARE N.V. |
JEFFERY A JEDLICKA |
| K090169 |
08/18/2009 |
SPECTRA FLUORESCENCE CARIES DETECTION DEVICE |
AIR TECHNIQUES, INC. |
NATALYA VALERIO |
| K091333 |
08/03/2009 |
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
| K091995 |
08/07/2009 |
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K090571 |
08/13/2009 |
ALMA LASERS ALEX755 MODULE |
ALMA LASERS LTD. |
HOWARD KELLY |
| K091548 |
08/07/2009 |
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEXANDER B HENDERSON |
| K091460 |
08/06/2009 |
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 |
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
JOHN GORMLEY |
| K091699 |
08/10/2009 |
AMSURE HYDROPHILIC LATEX FOLEY CATHETER |
AMSINO INTERNATIONAL, INC. |
JESUS FARINAS |
| K091306 |
08/21/2009 |
AMSURE PVC INTERMITTENT CATHETER |
AMSINO INTERNATIONAL, INC. |
HOLIVEN JI |
| K091737 |
08/18/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K091738 |
08/18/2009 |
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD |
ANDON HEALTH CO.,LTD |
LIU YI |
| K091739 |
08/18/2009 |
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K063461 |
08/13/2009 |
ANOVA CONTAINMENT DEVICE |
ANOVA CORPORATION |
CAMPBELL TUSKEY |
| K080564 |
08/14/2009 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
JEFF RYBERG |
| K090332 |
08/14/2009 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 |
ARKRAY Factory USA, Inc. |
HAMID IDRISSI |
| K091844 |
08/28/2009 |
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS |
ARTHREX, INC. |
IVETTE GALMEZ |
| K083707 |
08/03/2009 |
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE |
ARTHREX, INC. |
SALLY FOUST |
| K090107 |
08/06/2009 |
MINI TIGHTROPE |
ARTHREX, INC. |
SALLY FOUST |
| K091552 |
08/12/2009 |
SWITCH TRT |
AUDIFON GMBH & CO. KG |
JANE PERRONE |
| K090995 |
08/14/2009 |
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET |
B. BRAUN MEDICAL, INC. |
LISA GIAQUINTO |
| K090002 |
08/07/2009 |
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A |
BAXTER HEALTHCARE CORP. |
DONNA DJINOVICH |
| K091820 |
08/26/2009 |
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM |
BAYER HEALTHCARE |
MARC HENN |
| K083867 |
08/27/2009 |
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND |
BECKMAN COULTER, INC. |
TYLER FOUTCH |
| K091742 |
08/14/2009 |
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K091292 |
08/25/2009 |
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 |
BECTON DICKINSON AND COMPANY (BD) |
MARY ANN ALSBERGE |
| K092285 |
08/28/2009 |
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 |
BEST MEDICAL CANADA LTD. |
MARY HERBERT |
| K092223 |
08/12/2009 |
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
Angela Drysdale |
| K091899 |
08/14/2009 |
VITEK 2 GRAM NEGATIVE MEROPENEM |
BIOMERIEUX, INC. |
Nancy Weaver |
| K091976 |
08/17/2009 |
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL |
BIOMET TRAUMA |
MARGARET CROWE |
| K092078 |
08/05/2009 |
OPTILOCK PERIARTICULAR PLATING |
BIOMET TRAUMA |
SHIKHA GOLA |
| K090895 |
08/26/2009 |
EKG-PLUS II SOFTWARE |
BIONET CO., LTD. |
HL JUNG |
| K092064 |
08/07/2009 |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 |
BIOSENSE WEBSTER, INC. |
MELISSA SCHULTZ |
| K091705 |
08/28/2009 |
PRIMER PLUS |
BISCO, INC. |
Michelle Schiltz-Taing |
| K090586 |
08/07/2009 |
BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K082886 |
08/10/2009 |
ZOOM-100DC |
BRAINSCOPE COMPANY, INC. |
MICHAEL E SINGER |
| K091659 |
08/03/2009 |
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 |
C.R. BARD, INC. |
GAIL DOW |
| K091324 |
08/07/2009 |
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET |
C.R. BARD, INC. |
RICK GAYKOWSKI |
| K091821 |
08/25/2009 |
COMMANDER 111, MODEL CD300-CD399 |
CARDIOCOM LLC |
JULIE BULVER |
| K091461 |
08/14/2009 |
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE |
CARDIOPULMONARY CORP. |
JORDAN SCHRECK |
| K091396 |
08/05/2009 |
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM |
CARDO MEDICAL CORP. |
DENISE DUCHENE |
| K091186 |
08/18/2009 |
KODAK 1500 INTRAORAL CAMERA |
CARESTREAM HEALTH, INC. |
DANIEL HOEFER |
| K082016 |
08/10/2009 |
GDX VCC WITH ECC SOFTWARE |
CARL ZEISS MEDITEC INC. |
JUDITH A BRIMACOMBE |
| K091452 |
08/21/2009 |
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K091702 |
08/07/2009 |
CDB FLIP-SIDE-CLIP BRACKET |
CDB CORPORATION |
CHARLES VERNON |
| K090791 |
08/07/2009 |
DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% |
CENTURY PHARMACEUTICALS, INC. |
PAUL DRYDEN |
| K091251 |
08/25/2009 |
CERNER FETALINK (VERSION 1.0) |
CERNER CORP. |
SHELLEY S LOOBY |
| K091287 |
08/31/2009 |
VS-SENSE TEST |
COMMON SENSE, LTD. |
NATASHA LESKOVSEK |
| K083448 |
08/20/2009 |
CABLE, TRANSDUCER, MODEL 2400GN |
CONMED CORPORATION |
SARAH RIZK |
| K091856 |
08/07/2009 |
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES |
CONMED CORPORATION |
SANDRA COVELESKI |
| K091648 |
08/05/2009 |
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
| K090936 |
08/25/2009 |
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K091385 |
08/07/2009 |
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW |
COOK, INC. |
KAREN BRADBURN |
| K091971 |
08/27/2009 |
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM |
CORVENTIS, INC. |
MADHURI BHAT |
| K091626 |
08/07/2009 |
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH |
CRYOLIFE, INC. |
JOHN FERROS |
| K091134 |
08/17/2009 |
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
| K091706 |
08/28/2009 |
QUATTRO PORCELAIN SYSTEM |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K091041 |
08/07/2009 |
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
| K091453 |
08/12/2009 |
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K091753 |
08/28/2009 |
ELVIS HSV ID AND D3 TYPING TEST SYSTEM |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K092300 |
08/28/2009 |
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K091455 |
08/14/2009 |
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL |
DIAZYME LABORATORIES |
Abhijit Datta |
| K091430 |
08/21/2009 |
CARE PAL, MODEL CPW-10X |
DIGIO2 INTERNATIONAL CO., LTD |
JENNIFER REICH |
| K091381 |
08/07/2009 |
IBEX SPINAL SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K082040 |
08/27/2009 |
MINISILK FT |
EL.EN. ELECTRONIC ENGINEERING SPA |
ANDREA TOZZI |
| K090681 |
08/12/2009 |
TANSCU O2 |
ELECTROCHEMICAL OXYGEN CONCEPTS, INC. |
CARL JENKINS |
| K091497 |
08/19/2009 |
K-LASER K-1200, MODEL 12 W |
ELTECH, S.R.L. |
RICHARD ALBRIGHT |
| K091074 |
08/17/2009 |
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES |
ENCISION, INC. |
JUDITH KING |
| K091481 |
08/18/2009 |
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K083608 |
08/26/2009 |
ERBE HYBRID KNIFE |
ERBE USA, INC. |
JOHN TARTAL |
| K083053 |
08/07/2009 |
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K092299 |
08/07/2009 |
TRAILBLAZER SUPPORT CATHETER |
EV3 INC |
DAVID ROBERTSON |
| K083302 |
08/03/2009 |
LIFECARE ELECTRODES |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K090777 |
08/04/2009 |
EZC MEDICAL, LLC INTUBAIDFLEX |
EZC MEDICAL, LLC |
PAVAN SETHI |
| K090576 |
08/12/2009 |
FOOTPRINT URINARY DRAINAGE CATHETER |
FOOTPRINT MEDICAL |
CLYDE BAKER |
| K091773 |
08/07/2009 |
FUJINON STERILE OVERTUBES |
FUJINON, INC. |
JOSEPH M AZARY |
| K091533 |
08/17/2009 |
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 |
GARRISON DENTAL SOLUTIONS |
JOSEPH AZARY |
| K092004 |
08/25/2009 |
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ |
GE HEALTHCARE |
ALAN TOTAH |
| K092027 |
08/28/2009 |
CARESCAPE MONITOR B850 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOEL C KENT |
| K092140 |
08/21/2009 |
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND |
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
JAMES TURNER |
| K092079 |
08/06/2009 |
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND |
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
JAMES T TURNER |
| K091062 |
08/04/2009 |
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 |
GISH BIOMEDICAL, INC. |
JANET PEETS |
| K091782 |
08/13/2009 |
REVERE 6.35 STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K092108 |
08/13/2009 |
TRUSS THORACOLUMBAR PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K082723 |
08/31/2009 |
GRINDGUARD |
GRIND GUARD TECHNOLOGIES, LLC |
BILL MCLAIN |
| K080844 |
08/13/2009 |
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
| K090581 |
08/21/2009 |
TANTALUM BEAD SET, MODEL P003175 |
HALIFAX BIOMEDICAL, INC. |
ROSHANA AHMED |
| K092053 |
08/20/2009 |
MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH |
HANDPIECE HEADQUARTERS |
TIM ROPCHAN |
| K091338 |
08/26/2009 |
COLLASORB COLLAGEN WOUND DRESSING |
HARTMANN-CONCO INC. |
E.J. Smith |
| K092357 |
08/25/2009 |
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K090960 |
08/20/2009 |
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, |
HOLLISTER, INC. |
CHRIS STUKEL |
| K092405 |
08/27/2009 |
MAMMOSITE MULTI LUMEN |
HOLOGIC, INC. |
JENNIFER SULLIVAN |
| K092307 |
08/25/2009 |
IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR |
IMASIGHT INC |
JEAN CASAULT |
| K091238 |
08/13/2009 |
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ |
IMPACT INSTRUMENTATION, INC. |
LESLIE H SHERMAN |
| K083728 |
08/12/2009 |
INVISION SYSTEM |
INNEROPTIC TECHNOLOGY, INC |
CAROLINE GREEN |
| K090727 |
08/13/2009 |
IMM DENTAL IRRIGATION TUBING SET |
INNOVATIVE MEDICAL MANUFACTURING CO. |
JOSEPH J CHANG |
| K091763 |
08/14/2009 |
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 |
INSTRATEK, INC. |
Jeff Seavey |
| K091465 |
08/21/2009 |
MYOSURE ROD LENS HYSTEROSCOPE |
INTERLACE MEDICAL, INC. |
John Vozella |
| K091902 |
08/21/2009 |
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 |
INVIVO |
ELIZABETH WHEELER |
| K091629 |
08/11/2009 |
PROTEUS 235 PROTON THERAPY SYSTEM |
ION BEAM APPLICATIONS S.A. |
YVES JONGEN |
| K092136 |
08/07/2009 |
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 |
ISORAY MEDICAL, INC. |
FRED SWINDLER |
| K092458 |
08/28/2009 |
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 |
ISORAY MEDICAL, INC. |
FRED SWINDLER |
| K091193 |
08/10/2009 |
ACCELL EVO3C |
ISOTIS ORTHOBIOLOGICS, INC |
CARROLL COUNCILMAN |
| K090818 |
08/18/2009 |
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MONIKA CAMPBELL |
| K091357 |
08/10/2009 |
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K091039 |
08/07/2009 |
KOWA, FM-600, MODEL LSS50 |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K091098 |
08/07/2009 |
KOWAGENESIS-DF |
KOWA CO. LTD. |
AKIHIRO GUJITA |
| K090309 |
08/28/2009 |
LAGIS ENDOSCOPIC INSTRUMENTS |
LAGIS ENTERPRISES CO, LTD. |
JOSEPH J CHANG |
| K082947 |
08/14/2009 |
LENSX 550 LASER SYSTEM |
LENSX LASERS, INC. |
Judy Gordon |
| K092291 |
08/21/2009 |
SKINTACT AND VARIOUS OTHER TRADENAMES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K090456 |
08/26/2009 |
INSUFLOW |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K090343 |
08/11/2009 |
SENTINEL SPINAL SYSTEM |
LIFE SPINE |
MURALI AUDIPUDY |
| K090774 |
08/13/2009 |
LIGHTLAS SELECTOR |
LIGHTMED CORP. |
ANITA CHEN |
| K091682 |
08/20/2009 |
LSVT C OR LSVT COMPANION, MODEL V.1 |
LSVT GLOBAL, LLC |
DAVID H MCFARLAND |
| K091320 |
08/19/2009 |
SPECTRA SP II, SPECTRA DENTA II |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K091733 |
08/28/2009 |
VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 |
MAQUET CARDIOVASCULAR, LLC |
ARTIE KAUSHIK |
| K090662 |
08/10/2009 |
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K090048 |
08/14/2009 |
ASFORA BULLET CAGE SYSTEM |
MEDICAL DESIGNS, LLC |
KRISTI VONDRA |
| K090869 |
08/27/2009 |
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD |
MEDTRONIC PERFUSION SYSTEMS |
JESSICA SIXBERRY |
| K091365 |
08/06/2009 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOAFAMOR DANEK |
MELISA LANSKY |
| K090740 |
08/14/2009 |
MODIFICATION TO: TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LILA JOE |
| K091165 |
08/07/2009 |
HORIZON XVU |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K090710 |
08/20/2009 |
MERCURY CPAP |
MERCURY MEDICAL |
PAUL DRYDEN |
| K092343 |
08/07/2009 |
EN SNARE ENDOVASCULAR SNARE SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
GLENN NORTON |
| K081268 |
08/10/2009 |
SONIC AIR MM1500 + (MID), MODEL 50400014 |
MICRO-MEGA SOCIETE ANONYME |
ISABELLE BOURG |
| K091288 |
08/14/2009 |
MEDI-6000 MEDICAL IMAGE DIGITIZER |
MICROTEK INTERNATIONAL, INC. |
HUI-CHEN KAI |
| K090337 |
08/13/2009 |
TROPAZONE LOTION |
MIDLOTHIAN LABORATORIES |
BRYCE HARVEY |
| K081360 |
08/17/2009 |
PATHFAST CK-MB-II, PATHFAST MYO-II |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
| K082977 |
08/20/2009 |
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP |
MK BIO, INC |
Jane Zhang |
| K090240 |
08/06/2009 |
MONTERIS MEDICAL UFO |
MONTERIS MEDICAL |
CRAIG COOMBS |
| K092207 |
08/04/2009 |
RESTORELLE POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES INC |
CAROLINE STRETTON |
| K092203 |
08/12/2009 |
OMNISURE URETHRAL SLING, MODEL OTK52 |
MPATHY MEDICAL DEVICES, LTD. |
CAROLINE STRETTON |
| K090377 |
08/28/2009 |
SINUS QUICK EB SYSTEM |
NEOBIOTECH CO., LTD. |
JUNG B BANG |
| K083603 |
08/06/2009 |
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL |
NEURO KINETICS |
Aura Kullmann |
| K090811 |
08/27/2009 |
INSPIRA HD, MODEL: NL1000 |
NEUROLOGICA CORPORATION |
DONALD D FICKETT |
| K092235 |
08/06/2009 |
BEYONDIMAGE WORKSTATION |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K091279 |
08/12/2009 |
NIPRO DISPOSABLE SYRINGE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K092102 |
08/25/2009 |
NORDICBRAINEX SOFTWARE, VERSION 1.0 |
NORDICIMAGINGLAB AS |
CHANDANA GURUNG BHANDARI |
| K091398 |
08/26/2009 |
ARTHROSCOPE |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K092222 |
08/20/2009 |
THERMAPULSE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K091944 |
08/03/2009 |
MODIFICATION TO: DSS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
ADAM HERDER |
| K091600 |
08/25/2009 |
DIRECTVISION GUIDE SYSTEM |
PERCUVISION LLC |
ERROL O SINGH, M.D. |
| K091554 |
08/07/2009 |
PHARMAPAC PERSONAL LUBRICANT |
PHARMAPAC LLC |
TOM OTTO |
| K091230 |
08/12/2009 |
HDR PROSTATE TEMPLATE AND ACCESSORIES |
PHOTON TECHNOLOGIES CORPORATION |
JEFFREY A EDWARDS |
| K083087 |
08/07/2009 |
ECOCEL |
POLICHEM S.A. |
HARI NAGARADONA |
| K090781 |
08/13/2009 |
HELIO2 BLENDER |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K092500 |
08/20/2009 |
MODIFICATION TO PROFLU+ ASSAY |
PRODESSE, INC. |
KRISTINE SCHRAUFNAGEL |
| K091628 |
08/21/2009 |
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX |
PROTEC GMBH & CO. KG |
JOCHEN KRUPP |
| K092232 |
08/19/2009 |
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 |
PURICORE INC. |
DENNIS J MAHONEY |
| K083571 |
08/13/2009 |
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR |
PURNABINA SDN BHD |
ROBERT HILL |
| K090762 |
08/28/2009 |
LEDA |
QUANTEL DERMA GMBH |
DIETMAR FISCHER |
| K083208 |
08/25/2009 |
SATURN ACTIVE LASER SYSTEM |
RESEARCH INSTRUMENTS LTD. |
|
| K091129 |
08/03/2009 |
QUATTRO LT |
RESMED LTD. |
DAVID D'CRUZ |
| K091319 |
08/03/2009 |
REMSTAR AUTO A-FLEX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K092217 |
08/21/2009 |
MERCURY VCO2 |
RESPIRONICS NOVAMETRIX, INC. |
KEVIN MADER |
| K092043 |
08/05/2009 |
BIPAP SYNCHRONY 2 |
RESPIRONICS, INC. |
ZITA YURKO |
| K090750 |
08/05/2009 |
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
| K082699 |
08/19/2009 |
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS |
Roche Diagnostics |
JANE PHILLIPS |
| K091142 |
08/31/2009 |
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 |
RTI BIOLOGICS, INC. |
TRAVIS AROLA |
| K083382 |
08/13/2009 |
CHROMA, MODEL: RZ153C |
SCOTTCARE CORPORATION |
TIMOTHY J LEYVA |
| K092323 |
08/19/2009 |
CONTURA CAVITY MAINTENANCE CATHETER |
SENORX, INC. |
EBEN GORDON |
| K091408 |
08/18/2009 |
DISPOSABLE PRESSURE TRANSDUCER |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
LEE FU |
| K091521 |
08/10/2009 |
POWERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG CENTURY PLASTIC CO., LTD |
CHU XIAOAN |
| K091167 |
08/06/2009 |
SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES |
SHINA CORP. |
YONG NAM SHIN |
| K092022 |
08/17/2009 |
TISSU TRANS HARVEST TUBING |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH L SHIPPERT |
| K092519 |
08/27/2009 |
SYNGO.X |
SIEMENS AG, MEDICAL SOLUTIONS |
SVEN KNOKE |
| K091123 |
08/14/2009 |
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K091289 |
08/06/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K092073 |
08/07/2009 |
MONOPOLY PEDICLE SCREW SYSTEM |
SIGNUS MEDICAL |
THOMAS HOGHAUG |
| K083031 |
08/18/2009 |
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT |
SMITHS MEDICAL ASD, INC. |
JOHN TULLETT |
| K090304 |
08/28/2009 |
WAVEON WRX BONE FIXATION SYSTEM |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CARLOS GONZALEZ |
| K090342 |
08/11/2009 |
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 |
SOPHYSA SA |
ESTHER SALTZ |
| K092315 |
08/12/2009 |
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
BARRY SAIL |
| K091410 |
08/11/2009 |
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECCHIA |
| K092572 |
08/26/2009 |
CORE*IT DUAL |
SPIDENT CO., LTD. |
I.S. WHANG |
| DEN080011 |
08/07/2009 |
SNAP WOUND CARE DEVICE |
SPIRACUR, INC. |
JANICE M HOGAN |
| K092310 |
08/27/2009 |
SEGUIN ANNULOPLASTY RING |
ST. JUDE MEDICAL |
THOMAS RADEMACHER |
| K092075 |
08/07/2009 |
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K091158 |
08/10/2009 |
SCALAR WAVE LASER SYSTEM |
STELLAR LASERS |
Kevin Walls |
| K083097 |
08/03/2009 |
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
JOHN R SCOVILLE |
| K083643 |
08/07/2009 |
VERIFY 275F GRAVITY INDICATORS |
STERIS Corporation |
JOHN ROBERT SCOVILLE, JR. |
| K091970 |
08/12/2009 |
AIXPLORER ULTRASOUND SYSTEM |
SUPERSONIC IMAGINE |
JACQUES SOUQUET |
| K083582 |
08/26/2009 |
SIGN HIP CONSTRUCT (SHC), MODEL: 701 |
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
DOUGLAS J DONNELLY |
| K091439 |
08/25/2009 |
HEAD FIXATION ARC AND TABLE BASE |
SURGIVISION, INC. |
J. HARVEY KNAUSS |
| K091144 |
08/25/2009 |
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES |
SYNTHES (USA) |
ANDREA TASKER |
| K091897 |
08/25/2009 |
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 |
TaiDoc Technology Corporation |
ERICA LI |
| K090258 |
08/25/2009 |
VENTURI NPWT V. II ADVANCED VACUUM SYSTEM |
TALLEY MEDICAL |
JACK VAN DYKE |
| K090551 |
08/12/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K091633 |
08/07/2009 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
MARY P LEGRAW |
| K083747 |
08/20/2009 |
TERUMO PALL AL3X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K083758 |
08/14/2009 |
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS |
THE ELECTRODE STORE, INC. |
CARL YOUNGMANN |
| K091419 |
08/28/2009 |
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF |
THE PROCTER & GAMBLE CO. |
RICHARD J COOKE |
| K092423 |
08/26/2009 |
XPECT FLU A & B |
Thermo Fisher Scientific |
MARY A SILVIUS |
| K081246 |
08/13/2009 |
TT-102 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
YOUSEF MOHAJER |
| K092537 |
08/27/2009 |
DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 |
TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. |
JOHN KURZYDLO |
| K090783 |
08/20/2009 |
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE |
TUTTNAUER USA CO. LTD. |
THEODORE SULLIVAN |
| K090978 |
08/10/2009 |
UC-CARE WARMING SYSTEM |
UC-CARE LTD. |
JONATHAN S KAHAN |
| K091778 |
08/31/2009 |
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS |
VASCUTEK LTD. |
KAREN KELSO |
| K091412 |
08/21/2009 |
CLEAN PEAK FLOW METER |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K082329 |
08/05/2009 |
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K091768 |
08/03/2009 |
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES |
VISION-SCIENCES, INC. |
LILLIAN QUINTERO |
| K092486 |
08/28/2009 |
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT |
VORTEX MEDICAL INC |
BRIAN KUNST |
| K083429 |
08/07/2009 |
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
Diana Hong |
| K092201 |
08/20/2009 |
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH FAIRFIELD |
| K091423 |
08/25/2009 |
PROFEMUR HIP SYSTEM MODULAR NECKS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K083270 |
08/27/2009 |
WMT COMPOSITE DBM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K090199 |
08/11/2009 |
JIAJIAN ACUPUNCTURE NEEDLE |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K091200 |
08/21/2009 |
XTRACT SYRINGE KEYS |
XTRACT SOLUTIONS, LLC |
KEITH LOWREY |
| K090493 |
08/07/2009 |
SIGNAL |
ZARGIS MEDICAL CORP. |
JOHN KALLASSY |
