BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    LUM VASCULAR PROCEDURE SYSTEM #B5200A

    FDA 510(k)
    FDA Class 1 ·Radiology

    UNIVERSAL SLING, SLING & SWATHE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 19, 2014

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·October 26, 2010

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 21, 2012

    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