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    BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    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

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

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

    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

    BIVONA TTS TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

    BIVONA TTS TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

    BIVONA TTS TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 7, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 7, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 7, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 9, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 9, 2016

    CUSTOM BIVONA TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.,·Product code JOH·July 19, 2016

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 9, 2016

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885556076460·STAPLE 3/32 X 5/8 X 3/4

    RHODIA BITE REGISTRATION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental