BEUDAMED
    7 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    HYPOALLERGENIC SURGEON'S GLOVES - STERILE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EASY EYES TM CONTACT LENS CLEANING MACHINE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEVON SPONGE COUNTER BAGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·July 8, 2015

    REACH ACCESS DAILY FLOSSER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·January 15, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 4, 2014

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017