BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    INFRASONICS ADULT VENTILATOR TRENDING OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ST5500 UNIVERSAL CARE STRETCHER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 28, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 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