BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    EMDS ENZYME VERIFIER, LEVELS I & II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SATURN 3 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AirLife Autofill Humidification Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Injury ·AESCULAP INC·Product code KCT·October 12, 2016

    CAPSUREFIX

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 6, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 22, 2015

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Malfunction ·AESCULAP INC·Product code KCT·July 26, 2016

    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