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

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    COAT-A-COUNT CORTISOL RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

    FDA 510(k)
    FDA Class 1 ·Microbiology

    THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OR/GASTRO/DUODENAL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code FPD·March 26, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 2, 2007

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017