BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    BLADE, SURGICAL PREP RAZOR STRAIGHT

    FDA 510(k)

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074456362·INSTRUMENT 8880048 SL SAS SCRDRVER SILO

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867424753·Drill Guide, 1.5mm / 2.0mm

    AMINOGLYCOSIDE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MSK EXTREME MR SCANNER, MODEL AA5000

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL BIT, .059" (1.5MM)

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTW·December 22, 2023

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·October 13, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 19, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020