BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMG REPORT GENERATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    CARHILL ONE-WAY RESUSCITATION VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 5, 2010

    EFUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 27, 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