Data / Medical devices / Pump, Infusion / United States
FDA-registered makers of Pump, Infusion in the United States: 55 establishments
55 establishments in the United States are registered with the FDA to make Pump, Infusion (product code FRN). 35 have a 510(k) clearance or PMA approval on file and 15 have a recall event. FDA data exported November 2, 2026.
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- Device
- Pump, Infusion
- Product code
- FRN
- Country
- United States
Makers of Pump, Infusion 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 | 36 | April 2, 2025 | 0 | 55 | 12 | api.fda.gov |
| Icu Medical, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 14 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 7 | July 28, 2025 | 0 | 44 | 0 | api.fda.gov |
| CareFusion 303, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 7 | April 25, 2025 | 0 | 43 | 20 | api.fda.gov |
| Koru Medical Systems, Inc. | Mahwah, NJ, United States | Manufacturer, Specification developer | 7 | January 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 6 | August 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Iradimed Corporation | Orlando, FL, United States | Manufacturer, Specification developer | 4 | May 28, 2025 | 0 | 3 | 1 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | August 22, 2003 | 0 | 3 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer, Repackager or relabeler | 4 | August 22, 2003 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 3 | December 8, 2005 | 0 | 2 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | June 23, 2010 | 0 | 6 | 0 | api.fda.gov |
| CareFusion 303, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | April 25, 2025 | 0 | 8 | 1 | api.fda.gov |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 3 | March 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| WalkMed Technologies, LLC | Aurora, CO, United States | Manufacturer | 3 | July 1, 1999 | 0 | 5 | 0 | api.fda.gov |
| Belmont Medical Technologies | Billerica, MA, United States | Manufacturer | 2 | December 23, 2024 | 0 | 2 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Medina, NY, United States | Manufacturer, Specification developer | 2 | July 28, 2025 | 0 | 10 | 1 | api.fda.gov |
| Bayer Medical Care Inc. | Pittsburgh, PA, United States | Manufacturer | 2 | June 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 2 | May 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 2 | May 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| E-Z-Em, Inc. | Princeton, NJ, United States | Specification developer | 2 | April 14, 1989 | 0 | 0 | 0 | api.fda.gov |
| HK Surgical, Inc. | San Clemente, CA, United States | Specification developer | 2 | September 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 2 | March 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Manufacturer | 2 | March 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zevex, Inc. | Salt Lake City, UT, United States | Manufacturer | 2 | May 17, 2024 | 0 | 6 | 0 | api.fda.gov |
| American I.V. Products, Inc. | Harmans, MD, United States | Manufacturer | 1 | October 9, 2003 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | August 13, 1980 | 0 | 0 | 0 | api.fda.gov |
| Elixir Corporation | Suwanee, GA, United States | Manufacturer | 1 | October 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer, Remanufacturer | 1 | June 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi USA, LLC | North Andover, MA, United States | Manufacturer, Specification developer | 1 | June 7, 2019 | 0 | 18 | 10 | api.fda.gov |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 1 | December 9, 1985 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Specification developer | 1 | April 6, 1992 | 0 | 0 | 0 | api.fda.gov |
| Milestone Scientific, Inc. | Roseland, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 10, 2006 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 1 | March 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Wells Johnson Co. | Tucson, AZ, United States | Manufacturer | 1 | August 30, 1999 | 0 | 0 | 0 | api.fda.gov |
| Zyno Medical LLC. | Natick, MA, United States | Manufacturer, Specification developer | 1 | June 12, 2013 | 0 | 6 | 2 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 6 | 2 | api.fda.gov | |
| Bo-Mer Plastics | Auburn, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clarity Design, Inc. | Poway, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emed Technologies Corporation | El Dorado Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Health Sciences | Chester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation VH | Vadnais Heights, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MFG One, LLC | Chantilly, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIDE Industries | Roseville, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Planet Innovation Products, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBM Services, LLC. | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smisson-Cartledge Biomedical LLC | Macon, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| West Pharmaceutical Services AZ, Inc. | Scottsdale, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation | Burlington, MA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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.