BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    SpineJack Expansion Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493931903·AVANOS* Universal Block Trays

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651931907·HYH,UBLOCK,UBT,-,-,10

    FLEXI-LITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DC NEURO

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·June 21, 2013

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·ZYVEK·Product code LZH·July 21, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEMQ

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC·Product code LZG·October 14, 2014

    BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·September 14, 2022

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code LJE·December 31, 2024

    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