BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODEL AO-800PA CO2 MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOSCOPIC ASPIRATION CATHETER SET

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

    DIAMOND BURS-HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    9800

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

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 3, 2013

    SECURE II MED/SURG BED

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

    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