BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731601·GC Initial™ AL Gingival Universal GU, 20g

    BECKMAN SYSTEM E4A

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ROTATION BOOT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MICROFIX QA+#3/0 OC V-4W/BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·January 18, 2019

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2014

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·October 18, 2010

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·December 13, 2012

    MICROFIX QA+#3/0 OC V-4W/BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·July 21, 2017

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014