BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    VersaCross Transseptal Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    ELECSYS TOXO IGG CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OCTANE-C INTERBODY FUSION DEVICE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1ATRIXNEURO BURR HOLE COVER F/BURRHOLES-

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GXR·June 22, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 29, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·August 17, 2023

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·April 8, 2025

    TFNA HELICAL BLADE 100MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 12, 2018

    TI-SU03 GC

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

    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