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

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    TRIGEN META-TAN Trochanteric Antegrade Nail

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MDPC-8127

    FDA 510(k)
    FDA Class 2 ·Pathology

    EnSite X EP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·November 26, 2008

    UNKNOWN DEPUY SIGMA SZ 4 15MM RP STAB TIB INSERT

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code NJL·September 12, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ILS·July 23, 2013

    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    ACCOLADE DR SL MRI (Model L311)

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