BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    URIC ACID 75CDO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Rapid NCCT Stroke

    FDA 510(k)
    FDA Class 2 ·Radiology

    CANDELA SMOOTHBEAM LASER SYSTEM

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

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·February 5, 2014

    UNKNOWN LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·November 7, 2012

    CORAIL 2 NON COL HO SIZE 12

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·August 25, 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