BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    JANACEK TUBO-UTERINE IMPLANTATION SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OPTISOURCE, MODEL 1032P

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO-COMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSE BONE GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 30, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 20, 2012

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·September 17, 2010

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

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