BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SQUEEZE PLAY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Xpert C. difficile/Epi

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GBR System

    FDA 510(k)
    FDA Class 2 ·Dental

    BONE SCREW/LOCK, END CAPS, THREADED RECON SCREWS, CORTICAL SCREWS,

    FDA Adverse Event
    Malfunction ·BIOMET·Product code HRS·November 23, 2011

    QUARTET

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·February 5, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2010

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 18, 2014

    PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 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