BEUDAMED
    58 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA × Status: Open, Classified × Clear all

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    FDA Recall
    Open, Classified ·Kamiya Biomedical Company, LLC·Product code CFF·September 28, 2022

    Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KAI·February 23, 2024

    Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

    FDA Recall
    Open, Classified ·Synovo Production·Product code KXB·May 30, 2023

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    FDA Recall
    Open, Classified ·Synovo Production·Product code KXB·May 30, 2023

    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·March 10, 2023

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·April 22, 2022

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 3, 2025

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FPA·August 1, 2024

    The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·February 4, 2026

    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·December 6, 2024

    Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 29, 2023

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 21, 2025

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·January 10, 2025

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 14, 2025

    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·May 6, 2026

    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·March 7, 2024