BEUDAMED
    7 results · 47ms · Sources: EU EUDAMED, US FDA

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    AVANOS MEDICAL, INC.

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code BTR·June 5, 2025

    Navik 3D v2, REF NAVIK3D, 3D Mapping System

    FDA Recall
    Open, Classified ·APN Health LLC·Product code DQK·November 7, 2023

    Navik 3D v2, REF NAVIK3D, 3D Mapping System

    FDA Enforcement
    Class III ·Ongoing·APN Health LLC·December 20, 2023

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Sungo Cert GmbH

    Authorized representative
    🇩🇪 Germany·173 Manufacturers·3269 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices