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

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    DRS-4 DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Fujifilm Sonosite Vevo MD Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYN-O-SCOPE NASAL INHALER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    DISCOFIX 4 WAY STOPCOCK

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·October 29, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 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