BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    BARITONE C2 & BARITONE L3

    FDA 510(k)
    FDA Class 2 ·Dental

    MODEL #M9 ULTRACLAVE STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEGA SPINAL ANESTHESIA KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 3, 2020

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 14, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 12, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·July 3, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021