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

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    Filters Regulation: Us FDA ×

    N Series Patient Monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ProFlex CO2 Laser Fiber

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

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 30, 2014

    CONTOUR TS TEST STRIPS

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

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 9, 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