BEUDAMED
    11 results · 29ms · 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 ×

    Penumbra LP Coil System

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517570215·CoRoent Ant TLIF Ti, 13x10x28mm 4°

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464030231·OTICON MORE 3 MINIRITE T C090

    ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FOUNDATION

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWY·November 7, 2008

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    TOTAL ASR ACET IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    AxioGlass

    FDA UDI
    Axiodent Inc.·D161230280·

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025