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Icu Medical

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories5
Latest FDA decision2023-12-20

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-06). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K232048 Cogent™ Hemodynamic Monitoring System; Cogent™ HMSDXG2023-12-20 View
510(k) K192154 Rio Vial-to-Bag Drug Reconstitution DeviceLHI2020-04-20 View
510(k) K190918 SwabTip Male Disinfectant CapQBP2020-03-06 View
510(k) K190157 Diana ChemoClave Transfer SetONB2019-10-23 View
510(k) K171346 Sapphire SetsMRZ2017-08-25 View
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