28 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Enforcement
Class II
·Ongoing·KOB GmbH·March 18, 2026
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
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
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