BEUDAMED
    11 results · 31ms · Sources: EU EUDAMED, US FDA

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    Cypris eXact Suture Placement Device

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517442291·SpheRx II Tap, 8.5mm

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183990·Integra® Jarit® Cobb Style Bone Curette, 11", H...

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 18, 2002

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 23, 2002

    DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013