BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    HEMOCUE B-HEMOGLOBIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    C-STEM

    FDA UDI
    DEPUY (IRELAND)·10603295236801·C-STEM Revision Stem - Length 240mm SIZE 8 9/10...

    36MM BIOLOX DELTA CERAMIC HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sysmex Automated Blood Coagulation Analyzer CS-2100i

    FDA 510(k)
    FDA Class 2 ·Hematology

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·February 8, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 20, 2010

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·July 18, 2014

    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

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025