15 results
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16ms
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Sources: EU EUDAMED, US FDA
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, 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
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
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·April 19, 2023
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·December 27, 2023
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·April 17, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·September 11, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
FDA Enforcement
Class I
·Terminated·Fresenius Kabi USA, LLC·October 12, 2022