BEUDAMED
    12 results · 28ms · 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.

    DIFFUSION OPTION, OMNI-LAB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNIVERSAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·June 29, 2007

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 11, 2012

    NEURO SPG-1X1"-STERILE- 20/CS

    FDA Adverse Event
    Malfunction ·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025

    NEURO SPNG-1/2X3"-STRL- 20/CS

    FDA Adverse Event
    Malfunction ·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025

    NEURO-SP-1/2X1/2"-STRL 20/CS

    FDA Adverse Event
    Malfunction ·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025

    NEURO-SP-1/2X1/2"-STRL 20/CS

    FDA Adverse Event
    Malfunction ·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025

    NEURO-SP-1/2X1/2"-STRL 20/CS

    FDA Adverse Event
    Malfunction ·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025