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

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    LITEX 680

    FDA 510(k)
    FDA Class 2 ·Dental

    HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS

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

    UNI I

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    HUDSON ET TUBE, UNCUFFED, 2.5

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTR·June 12, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·February 11, 2013

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

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