700 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet
FDA Enforcement
Class I
·Ongoing·ICU Medical Inc·August 21, 2024
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
ICU Medical ChemoLock Port REF: CL2100
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical Plum Solos, Item number 400011001; infusion pump
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 25, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·September 7, 2022
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025