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

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    CRITIKON HEPARIN-COATED CARDIOVASCULAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 2, 2014

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 23, 2010

    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