BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    SONEX ULTRASONIC TOOTH BRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    ELECTROPULSE-COSMETIC

    FDA 510(k)
    FDA Class 2 ·Neurology

    BICART

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

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 23, 2010

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 14, 2013

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·July 3, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021