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

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    BIB Stent Placement Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code LFR·September 10, 2008

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024