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

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    TORQUE HANDLE DEVICE FOR GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DYNATRON 350 EMG/BIOFEEDBACK ANALYZER

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 12, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI PLANT - ST. PAUL·Product code LWS·July 1, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015