BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    BREEZY WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BALLOON PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUB-TALAR LOK, MODEL 7-11 MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 30, 2014

    AOS TROCHANTERIC NAIL

    FDA Adverse Event
    Injury ·ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·Product code HSB·October 20, 2010

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 19, 2012

    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020