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Icu Medical, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories8
Latest FDA decision2026-04-02
TypeNumberDevice NameCodeDateActions
510(k) K252130 LifeShield Infusion Safety Software SuitePHC2026-04-02 View
510(k) K252006 OTTO™ Disinfecting CapQBP2026-03-27 View
510(k) K251980 ClaveQS™ BagKPE2026-03-20 View
510(k) K250616 Clave™ Neutral-Displacement Needlefree ConnectorsFPA2025-06-05 View
510(k) K242115 Plum Duo™ Precision IV PumpFRN2025-04-02 View
510(k) K242114 Plum Solo™ Precision IV PumpFRN2025-04-02 View
510(k) K242117 LifeShield Infusion Safety Software SuitePHC2025-04-02 View
510(k) K243985 Rio™ Drug Reconstitution Transfer DeviceLHI2025-01-22 View
510(k) K223607 Plum Duo™ Infusion SystemFRN2023-08-24 View
510(k) K223606 LifeShield™ Infusion Safety Software SuitePHC2023-08-24 View
510(k) K173477 ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemONB2018-08-31 View
510(k) K170110 Diana Medication Transfer SetONB2018-08-10 View
510(k) K152006 Cogent Hemodynamic Monitoring SystemDXQ2016-05-05 View
510(k) K151969 Hospira Extension SetsFPA2016-01-19 View
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