Data / Medical devices / Infusion Safety Management Software / United States
FDA-registered makers of Infusion Safety Management Software in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Infusion Safety Management Software (product code PHC). 3 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Infusion Safety Management Software
- Product code
- PHC
- Country
- United States
Makers of Infusion Safety Management Software in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 4 | April 2, 2026 | 0 | 3 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 3 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Medina, NY, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| CareFusion 303, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CareFusion 303, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 2 | 1 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi USA, LLC | North Andover, MA, United States | Manufacturer, Specification developer | 0 | 0 | 2 | 1 | api.fda.gov | |
| Intego Software, LLC D/B/A Critical Alert | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.