BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021