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

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    BUN (ENZYMATIC BERTHELOT) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TEST, (IVDP) THYROID ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ALTA Anterior Cervical Interbody Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    AMVISC PLUS

    FDA Adverse Event
    Malfunction ·LIFECORE BIOMEDICAL, LLC·Product code LZP·November 21, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 22, 2015

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    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