BEUDAMED
    8 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 ×

    KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    IMUBIND TPA ELISA, MODEL 860

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD NEOFLON¿ IV CANNULA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 14, 2022

    SYNERGY

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS MED REL·Product code LGW·November 12, 2010

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·December 21, 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