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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer36April 2, 202505512api.fda.gov
Icu Medical, Inc.San Diego, CA, United StatesManufacturer, Specification developer14April 2, 2025000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer7July 28, 20250440api.fda.gov
CareFusion 303, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer7April 25, 202504320api.fda.gov
Koru Medical Systems, Inc.Mahwah, NJ, United StatesManufacturer, Specification developer7January 28, 2026000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer6August 13, 2003000api.fda.gov
Iradimed CorporationOrlando, FL, United StatesManufacturer, Specification developer4May 28, 2025031api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4August 22, 2003030api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer, Repackager or relabeler4August 22, 2003000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer3December 8, 2005020api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesComplaint file establishment, Manufacturer, Specification developer3June 23, 2010060api.fda.gov
CareFusion 303, INCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3April 25, 2025081api.fda.gov
Deka Research & Development Corp.Manchester, NH, United StatesSpecification developer3March 11, 2025000api.fda.gov
WalkMed Technologies, LLCAurora, CO, United StatesManufacturer3July 1, 1999050api.fda.gov
Belmont Medical TechnologiesBillerica, MA, United StatesManufacturer2December 23, 2024020api.fda.gov
Baxter Healthcare CorporationMedina, NY, United StatesManufacturer, Specification developer2July 28, 20250101api.fda.gov
Bayer Medical Care Inc.Pittsburgh, PA, United StatesManufacturer2June 23, 2010000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer2May 12, 1999000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer2May 12, 1999000api.fda.gov
E-Z-Em, Inc.Princeton, NJ, United StatesSpecification developer2April 14, 1989000api.fda.gov
HK Surgical, Inc.San Clemente, CA, United StatesSpecification developer2September 27, 2013000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesComplaint file establishment, Manufacturer2March 11, 2025000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesManufacturer2March 11, 2025000api.fda.gov
Zevex, Inc.Salt Lake City, UT, United StatesManufacturer2May 17, 2024060api.fda.gov
American I.V. Products, Inc.Harmans, MD, United StatesManufacturer1October 9, 2003000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1August 13, 1980000api.fda.gov
Elixir CorporationSuwanee, GA, United StatesManufacturer1October 23, 2008000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer, Remanufacturer1June 7, 2019000api.fda.gov
Fresenius Kabi USA, LLCNorth Andover, MA, United StatesManufacturer, Specification developer1June 7, 201901810api.fda.gov
Haemonetics CorporationBoston, MA, United StatesSpecification developer1December 9, 1985000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Specification developer1April 6, 1992000api.fda.gov
Milestone Scientific, Inc.Roseland, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1July 10, 2006000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1March 9, 1998000api.fda.gov
Wells Johnson Co.Tucson, AZ, United StatesManufacturer1August 30, 1999000api.fda.gov
Zyno Medical LLC.Natick, MA, United StatesManufacturer, Specification developer1June 12, 2013062api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer for export0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0062api.fda.gov
Bo-Mer PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Clarity Design, Inc.Poway, CA, United StatesContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Emed Technologies CorporationEl Dorado Hills, CA, United StatesSpecification developer0000api.fda.gov
Innovative Health SciencesChester, NY, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
IntriCon Corporation VHVadnais Heights, MN, United StatesContract manufacturer0000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
PRIDE IndustriesRoseville, CA, United StatesContract manufacturer0000api.fda.gov
Planet Innovation Products, Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
RBM Services, LLC.Knoxville, TN, United StatesContract manufacturer0000api.fda.gov
Smisson-Cartledge Biomedical LLCMacon, GA, United StatesSpecification developer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
West Pharmaceutical Services AZ, Inc.Scottsdale, AZ, United StatesContract manufacturer0000api.fda.gov
scPharmaceuticals Inc., a wholly owned subsidiary of MannKind CorporationBurlington, MA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.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.