BEUDAMED
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    Filters Classification: Class Iii × Status: Terminated × Clear all

    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

    FDA Enforcement
    Class III ·Terminated·Boston Scientific Corporation·July 17, 2013

    EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

    FDA Enforcement
    Class III ·Terminated·Boston Scientific Corporation·May 5, 2021