BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    EXTERNAL FEEDING SET FOR PUMP USE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRASONIC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STAT TEMP MODEL 4800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 5, 2015

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·December 29, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020