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

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    Monotime and Optime R

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

    QUADROX-IR ADULT AND SMALL ADULT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    nPro Surgical Mask

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

    EDWARDS PERICARDIAL PATCH

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DXZ·November 13, 2008

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·September 2, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021