BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    INSTRUMENT TRAY LINER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PEEK Corpectomy

    FDA UDI
    Nuvasive, Inc.·00887517623072·PEEK Corp Core, Ø12x17mm

    DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLADDERSCAN BVI 9400 ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·February 6, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 26, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 8, 2014

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

    ACCESS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·CLARE DISCRETE MFG IO·Product code QKO·October 22, 2020

    ACCESS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·CLARE DISCRETE MFG IO·Product code QKO·October 26, 2020

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    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