BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STRESS HANDLER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SMARTSITE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·February 1, 2013

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 4, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 21, 2014

    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