BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 20, 2025

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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