BEUDAMED
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    REVELATION STEM, MODEL 427-21/42-080/180

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B582083651·RETRACTOR, ALL TYPES

    INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AURORA

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVALIGN

    FDA Adverse Event
    Malfunction ·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019

    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

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013

    TENDRIL SDX

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

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 28, 2008

    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