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

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    Filters Regulation: Us FDA ×

    CER-S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIDI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCU-CHEK COMPACT PLUS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code NBW·October 28, 2008

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 17, 2011

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·July 3, 2013

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019