BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    MODEL BPS08 BLOOD PRESSURE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMARTSET MV BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TECHNICON H6000 HEMATOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·October 1, 2010

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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