BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nathanson Transcystic Bile Duct Stone Exploration Pack

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CPAP MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYLOS DR

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·June 13, 2014

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·October 16, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 13, 2012

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

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