BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biograph mCT and mCT Flow PET/CT Scanners

    FDA 510(k)
    FDA Class 2 ·Radiology

    NORWOOD ABBEY CENTURION SES EPIKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SIGMA HP UNI TIB TRAY SZ4 LMRL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·June 5, 2014

    SELOX ST 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE AND CO. KG·Product code NVZ·October 31, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010

    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