BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KODATROL I AND II CONTROL AND DILUENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TERUMO SENSIBEAD EIA HPRL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·February 11, 2013

    CURRENT ACCEL VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code DTK·July 18, 2014

    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