BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sonicision Cordless Ultrasonic Dissection Device

    FDA 510(k)
    FDA Unclassified ·Unknown

    AMS MALE TRANSOBTURATOR SLING SYSTEM

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

    COUDE/ OR TIEMANN

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

    VITALITY AVT

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    TBD

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 8, 2013

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    FREE STYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023