ICU Medical, Inc.
IV therapy, infusion management, and oncology systems for hospitals worldwide.
ICU Medical is a global manufacturer of innovative medical devices used in infusion therapy, critical care, and oncology applications, including IV sets, needlefree connectors, catheters, closed-system drug transfer devices, and infusion pumps. The company acquired Hospira Infusion Systems from Pfizer, adding a large portfolio of large-volume IV solutions and critical care products to its device business. ICU Medical sells to hospital systems, group purchasing organizations, and healthcare distributors across more than 100 countries.
- Type
- Manufacturer
- Location
- San Clemente, CA, United States
- Founded
- 1984
- Website
- icumedical.com
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, United Kingdom, Germany, Australia, Canada, Japan, France
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)