BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    CIRCON ACMI BICAP III THERAPEUTIC SYSTEM

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

    PBC IV SET VENTED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TENSION-ISOMETER

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

    ELITE, ROLL AROUND INJ SYSTEM

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM COMPANY·Product code DXT·May 20, 2014

    MITRAL PROSTHETIC HEART VALVE

    FDA Adverse Event
    ATS MEDICAL INC.·Product code LWR·October 18, 2010

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·December 21, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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