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

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    4LYF OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINACwatch, LinacView

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIO-MAT 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALARIS SYRINGE PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·May 21, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·October 8, 2010

    VITAMIN D TOTAL (VITD) ADVIA CENTAUR ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MRG·December 13, 2012

    TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·November 1, 2019

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024