BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    SYNERGY POROUS SIZE 8 HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MUELLER HINTON AGARS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Deflectable Brush Biopsy Set

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

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 6, 2013

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code JJE·January 28, 2011

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·August 8, 2014

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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