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

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    TRANSCUTANEOUS OXYGEN MONITOR OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OMNIFIT HFX HIP STEM SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE

    FDA 510(k)
    FDA Unclassified ·Unknown

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    MINIARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 9, 2012

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 2010

    NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·March 4, 2015