BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTRINSIC THERAPEUTICS FIXATION STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OpClear System

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

    INTERNAL MIDFACE DISTRACTOR, 20MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·February 21, 2013

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 27, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·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