BEUDAMED
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    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    FDA Enforcement
    Class III ·Ongoing·DRG International, Inc.·November 6, 2024

    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

    FDA Enforcement
    Class III ·Ongoing·Sentinel CH SpA·July 14, 2021

    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