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

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    REAGENT FOR DETERM. POTASSIUM/IN HUMAN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MACS CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIGITAL SPOT MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    Fisher Wallace Stimulator Models FW-100 and FW-200

    FDA Recall
    Open, Classified ·Fisher Wallace Laboratories Inc.·Product code QJQ·April 6, 2023

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023