BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    MONARK ERGOMETERS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips MR Patient Care Portal

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 11, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    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