BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    DENLEY WELLPREP 2 SAMPLE PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NOVUS SPECTRA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VOLUSON E6/E8/E8EXPERT/E10

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·July 9, 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