BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Intera Refill Kit

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KNIGHTSTAR 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·October 22, 2008

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 4, 2011

    AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 3, 2013

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019