BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    ALT-30, 60 AND 100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DENLASER 800 PLUS

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

    ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    PS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 7, 2012

    LEECHES

    FDA Adverse Event
    RICARIMPEX SAS·Product code NRN·June 18, 2015

    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