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

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.

    FDA Enforcement
    Class II ·Ongoing·Tandem Diabetes Care Inc·July 25, 2018

    20" Lead Wires, Replacement Part Number: 1067724-2

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    48" Lead Wires, Replacement Part Number: 1067724-4

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·January 21, 2026

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·December 10, 2025

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    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 Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·October 4, 2023

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·November 5, 2025

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

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025