BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

    FDA 510(k)
    FDA Class 2 ·Dental

    MELIDE FIBEROPTIC LIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 14, 2014

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code MMI·August 31, 2011

    GEMINI PCI INFUSION PUMP

    FDA Adverse Event
    Injury ·CAREFUSION CORPORATION·Product code FRN·July 17, 2013

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

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