BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

    FDA 510(k)
    FDA Class 2 ·Immunology

    INFINION 0.6T MR IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEGABEAM ENDO-ENT PROBE

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

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·October 22, 2008

    BREEZE2 TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·August 4, 2011

    INFINITY DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013

    DEKA SMARTPERIO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024

    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