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

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    MAX FRAME DESIGN

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    COBAS FP TDM CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNK CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019

    PS TIBIAL INSERTS SZ 1, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 11, 2024

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·February 5, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·December 1, 2010

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 18, 2014

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018

    THREADED PERSUADER-STANDARD

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·March 20, 2014

    ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

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