BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    COULTER CARBON DIOXIDE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WACKERS-LIU CQ SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THYRETAIN TM TSI REPORTER BIOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·June 24, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·January 8, 2013

    ENDOPATH** XCEL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 18, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025