BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    PEN-INJECT 2.25

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADAM (ABSORBENT INCONTINENCE SHIELD)

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    BLOM-SINGER SHOWER GUARD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·February 11, 2013

    ATLAS II VR

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

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·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