BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Atellica® CH Creatinine_3 (Crea3)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    METRICATH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 23, 2013

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Asheville) LLC·April 17, 2013