BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    LDH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THE MEDCOMP .010 VASCULAR GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Blood and IV Fluid Infusion Warmer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VARIO-CUP

    FDA Adverse Event
    Malfunction ·WALDEMAR LINK GMBH & CO. KG·Product code KWY·June 13, 2025

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·June 26, 2007

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·Product code JWH·October 11, 2012

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020