BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    INTESTOPLANT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981144692·Modular Trial 20x15x12mm, 10 Deg Lordosis, w/ D...

    Hoggan Scientific® microFET2™

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRYOMATIC

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CARELINK

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    WALLFLEX¿ BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    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