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
FDA 510(k) Regulatory Record - Icu Medical General Hospital ✕
5 devices
Cleared
Sep 18, 2026
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501,...
General Hospital
58d
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