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ICU Medical FDA Approvals

0 new drug approvals and 2 device clearances on file. Matched by name to ICUI.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)510(k)Sep 18, 2026General Hospital
Cogent™ Hemodynamic Monitoring System; Cogent™ HMS510(k)Dec 20, 2023Cardiovascular

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