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Icu Medical, Inc.

FDA 510(k) & PMA Approved Devices — 65 products

Total Devices65
Categories0
Latest FDA decision
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) K223606 LifeShield™ Infusion Safety Software SuitePHC2023-08-24 View
510(k) K223607 Plum Duo™ Infusion SystemFRN2023-08-24 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
510(k) K131549 CHEMOLOCK, CHEMOLOCK PORTONB2013-07-26 View
510(k) K100576 HIGH PRESSURE SETS-400 PSIFPA2010-12-17 View
510(k) K100434 CLAVE NEUTRONFPA2010-07-09 View
510(k) K090189 ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVEFPA2009-04-10 View
510(k) K082806 SPINNING SPIROS, MODEL CH-2000FPA2009-04-06 View
510(k) K082836 ICU MEDICAL UNIVERSAL SINGLE-USE SPIKESFMG2009-02-25 View
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