BEUDAMED
    8 results · 35ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Microbiology

    3B WILLOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4

    FDA 510(k)
    FDA Class 2 ·Radiology

    MERGE CARDIO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC ABLATION FRONTIERS·Product code DRF·June 27, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018