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

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    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CEDIA(R) CARBAMAZEPINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 11, 2019

    REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH

    FDA Adverse Event
    Malfunction ·SKILLMAN CONTRACT·Product code EFW·February 5, 2013

    WELLFLEX BILIARY RX STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·January 3, 2011

    UNKNOWN DEPUY SZ. 40 LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code KWA·July 18, 2014

    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