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

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    HEMODIALYSIS CONCENTRATE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198765·AK3 Ultra Insert Trial Size 5, 13mm

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707067511·LIGATING MODULES 1,3mm TRANSPARENT

    RAINBOW BLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    HLA-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SLALOM PTA DILATATION CATHETER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code LIT·October 16, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code CGA·April 29, 2015

    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. 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