BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·General Hospital

    Philips IntelliVue GuardianSoftware

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOX PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·February 9, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 6, 2011

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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