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

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    Byte Aligner System

    FDA 510(k)
    FDA Class 2 ·Dental

    CLARITY LPC LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    CUSTOM PAK

    FDA Adverse Event
    Injury ·ALCON - HOUSTON·Product code KYG·November 13, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 16, 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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025