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

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    TARGET(TM) CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Confirm Rx Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BODYVIZ, MODEL 100

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANUFLO

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

    FOX PLUS PTA CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-BERINGEN·Product code LIT·October 22, 2010

    HEALICOIL - PK

    FDA Adverse Event
    Malfunction ·MANSFIELD MANUFACTURING SITE·Product code MBI·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