BEUDAMED
    9 results · 20ms · 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 ×

    SORBIE TOTAL ELBOW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELEGANCE TSH ELISA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 1, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 1, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·February 11, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    UNKNOWN URETEX MESH PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·July 22, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021