BEUDAMED
    7 results · 23ms · 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.

    MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Isolette 8000 plus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·June 13, 2014

    CONSTELLATION

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 14, 2010

    LRG TAP PRI MOD NCK 0DEG 30MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012

    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