BEUDAMED
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    DEKA Infusion System, DEKA Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707067221·LIGATURES MINI modules TRANSP LARGE

    ORION E ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    MULTIVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTMATE 3 VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 10, 2022

    HEARTMATE 3 VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·April 15, 2020

    HEALTHLINE MEDICAL

    FDA Adverse Event
    Malfunction ·HEALTHLINE·Product code INM·June 24, 2014

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·August 18, 2011

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·December 18, 2012

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·November 22, 2019

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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