BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    SKYTRON ELITE 3100 SURGICAL TABLE

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

    DeGen Medical Patient Specific Implant (PSI) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Atlas SPEEDER Header/Neck

    FDA 510(k)
    FDA Class 2 ·Radiology

    4 FR SL GROSHONG NXT CLEARVUE BASIC KIT

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD)·Product code LJS·April 11, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·November 29, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 17, 2015

    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