BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUICK COMBO PAD

    FDA Adverse Event
    Injury ·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997

    Afinion HbA1c Dx

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THERAPY SCOOTER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LAMITRODE 88 PADDLE LEAD

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 19, 2010

    SPECTRUM INFUSION PUMP

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

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·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