BEUDAMED
    11 results · 36ms · Sources: EU EUDAMED, US FDA

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    TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613025342·Mayo Harrington Scissors, Straight, Overall Len...

    UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STAPHYLOCOCCUS QUICKFISH BC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ATTUNE IMPACTION HANDLE

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 14, 2015

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 11, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 3, 2014

    SMALLBORE BIFUSE EXT. SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·April 28, 2015

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    FREE STYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015