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

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    IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BiomarC Fiducial Marker

    FDA 510(k)
    FDA Class 2 ·Radiology

    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 6, 2013

    REVEAL DX

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code DSI·February 15, 2011

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 8, 2014

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    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