BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    FILLING VOLUME OPTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SURGI TEK'S DISPOS. INNER CANNULA FOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POLY FLEX IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    SYNFRAME HALF RING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·December 20, 2012

    SIGN I. M. NAIL

    FDA Adverse Event
    Injury ·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·October 20, 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