BEUDAMED
    13 results · 58ms · Sources: EU EUDAMED, US FDA

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    500 INFUSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES

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

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

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

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

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.,·Product code JOH·July 16, 2016

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

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

    BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 27, 2017

    REPLY

    FDA Adverse Event
    Injury ·SORIN C.R.M., S.R.L.·Product code NVZ·January 10, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 17, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 6, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015