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

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    SURGEONS CAP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Tyber Medical PT Interbody Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MARYLAND BIPOLAR FORCEPSINSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 18, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·October 26, 2010

    ADVANTAGE FIT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 20, 2012

    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