BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    ClearPoint System (Software Version 3.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEEPVESSEL FFR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vu-Path Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025