BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    VERSABLOT

    FDA 510(k)
    FDA Class 1 ·Pathology

    HODGE DECOMPRESSION TUBE

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

    PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014

    ETHICON HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ASCENT HEALTHCARE SOLUTIONS·Product code LFL·October 22, 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) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

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