BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    HHI PNEUMATIC ROTARY DRILL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    A1CNOW FOR HOME USE

    FDA 510(k)
    FDA Class 2 ·Hematology

    VITAL 5 RELEAF CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·December 27, 2012

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    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