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

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    ViewPoint 6

    FDA 510(k)
    FDA Class 2 ·Radiology

    T-QUEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    THE SENSITITRE AIM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 10, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2011

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 28, 2013

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021