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

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

    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

    FDA Enforcement
    Class III ·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026

    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

    FDA Enforcement
    Class III ·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026

    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

    FDA Enforcement
    Class III ·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026

    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

    FDA Enforcement
    Class III ·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026

    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

    FDA Enforcement
    Class III ·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026

    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