Icu Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LifeShield Infusion Safety Software Suite, OTTO™ Disinfecting Cap, ClaveQS™ Bag
66
Total
65
Cleared
0
Denied
FDA 510(k) Regulatory Record - Icu Medical, Inc. General Hospital ✕
55 devices
Cleared
Apr 02, 2026
LifeShield Infusion Safety Software Suite
General Hospital
269d
Cleared
Mar 27, 2026
OTTO™ Disinfecting Cap
General Hospital
273d
Cleared
Mar 20, 2026
ClaveQS™ Bag
General Hospital
266d
Cleared
Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
General Hospital
97d
Cleared
Apr 02, 2025
Plum Solo™ Precision IV Pump
General Hospital
257d
Cleared
Apr 02, 2025
Plum Duo™ Precision IV Pump
General Hospital
257d
Cleared
Apr 02, 2025
LifeShield Infusion Safety Software Suite
General Hospital
257d
Cleared
Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
General Hospital
30d
Cleared
Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
General Hospital
265d
Cleared
Aug 24, 2023
Plum Duo™ Infusion System
General Hospital
265d
Cleared
Aug 31, 2018
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
General Hospital
291d
Cleared
Aug 10, 2018
Diana Medication Transfer Set
General Hospital
575d
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