BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Medical Radiation Dosimetry System microSTARii

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASAHI REXEED-S DIALYZERS

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·March 1, 2013

    INPECO SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JQP·February 15, 2011

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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