BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    AS-10, CXDI-401RF

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAPHAEL COLOR ASV VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 15, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

    OXISENSOR II, N25

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DQA·April 14, 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