Medical Device Manufacturer · US , Walker , MI

Icu Medical, Inc. - FDA 510(k) Cleared Devices

64 submissions · 63 cleared · Since 1984

64

Total

63

Cleared

0

Denied

FDA 510(k) cleared devices by Icu Medical, Inc. General Hospital ✕

53 devices

1-12 of 53

Cleared Mar 20, 2026

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

Cleared Jan 19, 2016

Hospira Extension Sets

General Hospital · 187d

Cleared Jul 26, 2013

CHEMOLOCK, CHEMOLOCK PORT

General Hospital · 58d

Looking for a specific device from Icu Medical, Inc.? Search by device name or K-number.

Search all Icu Medical, Inc. devices