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    BIVONA TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 3, 2018

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 15, 2016

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 19, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 12, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

    PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·July 10, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 30, 2016

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 30, 2016

    PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 10, 2017

    PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 10, 2017