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

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    AMPCARE ESP THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131255822·SENSEI, BTE 13 WL 90 BP

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012141·SHEA OVAL CUP ALLIGATOR FORCEPS CURVED UP 4 MM ...

    Intramedullary Plugs

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575036899·Intramedullary Plug Impactor, threaded, L=400 m...

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    SCANLUBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MRI-Q SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962110614·SUTURE WIRE, 22 GAUGE

    TRILOGY 02

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 23, 2013

    UNK

    FDA Adverse Event
    TORNIER INC.,·Product code KWH·August 19, 2014

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·June 16, 2011

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015