BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    Pre-Formed Silicone Block

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    INTRAUTERINE DELIVERY SYSTEM - INJECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    HELIX BLADE 85MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code KTT·November 4, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013

    ACCOLADE DR SL MRI (Model L311)

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