BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    RESCUE PACK

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

    SONIK LDI 20 AIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OMNI-VUE 2 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 13, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 13, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2015

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    FDA Enforcement
    Class II ·Ongoing·Isopure Corp·July 20, 2022