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

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    AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RTX RESPIRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·June 16, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 28, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 9, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

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