BEUDAMED
    3 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    AcoSound. Model Number: LW12-BTE-M

    FDA Enforcement
    Class III ·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Enforcement
    Class III ·Ongoing·Olympus Corporation of the Americas·May 31, 2023

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Enforcement
    Class III ·Ongoing·Olympus Corporation of the Americas·May 31, 2023