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.
    Filters Regulation: Us FDA ×

    NOVA 11 NA/K/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELUXE SANITARY PAD

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ACTH IRMA KIT MITSUBISHI YUKA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 16, 2014

    TOTAL ASR FEM IMP SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·January 15, 2013

    AMPLATZER® SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·December 6, 2010

    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