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

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    VISTA SINGLE CHIP VIDEO CAMERA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STRYKER SPINE XIA III SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M Bair Hugger Model 675 Total Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XIA 3 TITANIUM BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-SWITZERLAND·Product code MNI·January 21, 2016

    UNI LFIT MEDIAL FEMORAL COMP.

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code HRY·April 15, 2013

    T.W. POWER SUPLPY

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code HQO·February 4, 2013

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·January 27, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    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