BEUDAMED
    2 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024