26 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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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
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Enforcement
Class I
·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
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 Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·December 10, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·December 24, 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 LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·June 18, 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 Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·February 12, 2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·January 15, 2025
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·October 2, 2024
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