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

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    OVUSTICK SELF-TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOASSIST

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

    Elecsys Estradiol III Calcheck

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 30, 2020

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 2, 2014

    REACH TOOTHBRUSH UNSPECIFIED

    FDA Adverse Event
    Malfunction ·SKILLMAN CONTRACT·Product code EFW·November 22, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·September 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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