BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HCL LABORATORY SYSTEMS 200 -LISA-

    FDA Adverse Event
    Other ·HYCEL DIAGNOSTICS·Product code JJF·November 8, 2000

    EUREKA EXTENSION CYLINDERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SWANSON TITANIUM TRAPEZIUM IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2014

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 20, 2011

    FT3 - FREE TRIIODOTHYRONINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·July 21, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·May 20, 2014

    FT3 - FREE TRIIODOTHYRONINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·April 30, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·March 24, 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