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

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    PERITONEAL CATHETERS WITH AN ADDED FUNCTION

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

    ORTHADAPT PR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Arthrex Tenodesis Button

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    PRECISION XTRA

    FDA Adverse Event
    Injury ·Product code NBW·November 3, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 29, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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