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

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    CorPath GRX System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLUE POWER FREE NITRILE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Altapore MIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Death ·COOK INC.·Product code DQY·November 4, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR·Product code MVK·July 2, 2013

    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