BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    HeartFlow Analysis

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIMSTEP PREGNANCY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    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

    MINIMARK DENTAL IMPLANT SYSTEM

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

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021