BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRE-DENT SYSTEM OR PRE-DENT II

    FDA 510(k)
    FDA Class 1 ·Hematology

    ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012