BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON CX3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS

    FDA 510(k)
    FDA Class 1 ·Hematology

    PRISTINE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 10, 2014

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 11, 2010

    UNKNOWN DEPUY ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·December 10, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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