BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    LEUCOPREP BRAND TUBE

    FDA 510(k)
    FDA Class 1 ·Hematology

    FIBER OPTIC ADAPTER #60-0896

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

    MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 13, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code DZL·December 13, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 26, 2015

    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 2, 2014