Icu Medical is one of 16081 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Icu Medical - FDA 510(k) Cleared Devices
Recent clearances: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61), Cogent™ Hemodynamic Monitoring System, Rio Vial-to-Bag Drug Reconstitution Device
6
Total
6
Cleared
0
Denied
Icu Medical has 6 FDA 510(k) cleared medical devices. Based in Lake Forest, US.
Latest FDA clearance: Sep 2026. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Icu Medical Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Icu Medical
6 devices
Cleared
Sep 18, 2026
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501,...
General Hospital
58d
Cleared
Dec 20, 2023
Cogent™ Hemodynamic Monitoring System
Cardiovascular
163d
Cleared
Apr 20, 2020
Rio Vial-to-Bag Drug Reconstitution Device
General Hospital
255d
Cleared
Mar 06, 2020
SwabTip Male Disinfectant Cap
General Hospital
332d
Cleared
Oct 23, 2019
Diana ChemoClave Transfer Set
General Hospital
266d
Cleared
Aug 25, 2017
Sapphire Sets
General Hospital
109d