BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    NeuroOne Cortical Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESOLUTION II CLIP

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

    RAPID STRAND RX

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNICONDYLAR KNEE SYSTEM

    FDA Adverse Event
    Injury ·STELKAST, INC.·Product code JWH·October 8, 2008

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·July 20, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    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