BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    SILICONE Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ZOLL IVTM SOLEX 7 CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·February 14, 2024

    FD TENS 2070

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPROVIS IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    TOTAL ASR ACET IMP SIZE 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·June 26, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 1, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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