BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756554312·LAMINECTOMY TRAY

    ER-REBOA PLUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHILLY BOLT

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code GCC·January 22, 2021

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 19, 2014

    ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FPA·June 3, 2014

    AQVATRACK

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES·Product code DQX·November 5, 2010

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 29, 2008

    LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET

    FDA Adverse Event
    Malfunction ·COOK VANDERGRIFT INC·Product code GCC·March 9, 2022

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017