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

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    Exo Iris (El2001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452

    FDA 510(k)
    FDA Class 2 ·Neurology

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 3, 2014

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

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