BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFIED DELFIA ESTRADIOL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MDI GLIADIN A TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZIP'R3/ ZIP'R3 XTRA SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 8, 2013

    VENTED SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·November 18, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 30, 2014

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025