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

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    INCENTIVE SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

    FDA 510(k)
    FDA Class 2 ·Hematology

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    AIRLIFE

    FDA Adverse Event
    Malfunction ·CAREFUSION 211, INC.. DBA CAREFUSION·Product code BTT·April 1, 2014

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN CRM·Product code MRM·September 26, 2012

    ARROW

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code KGZ·July 13, 2010

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025