BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Disposable Surgical Face Mask

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

    REVEAL LINQ INSERTABLE CARDIAC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 19, 2011

    CAREFUSION

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·September 12, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025