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

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    PFISTER-SCHWARTZ STONE RETRIEVER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293289·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117919·MODULAR TIBIA PUNCH DART Size 5-6

    K-Wire w. double end trocarpoint 1.1mm/229mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM713020·K-Wire w. double end trocarpoint 1.1mm/...

    ELECTRONIC BLOOD PRESSURE UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUTTER, P606 BONE

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

    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 19, 2017

    UNKNOWN

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code MDI·April 24, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·October 4, 2012

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 27, 2010

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025