BEUDAMED
    7 results · 17ms · 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.

    MASK, OXYGEN, NONBREATHING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    uCT 530, uCT 550

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO CORAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PATELLA CLAMP

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 10, 2012

    FLOTRAC SENSOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DRS·August 3, 2010

    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 19, 2017