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Data / Medical devices / Filter, Infusion Line / United States

FDA-registered makers of Filter, Infusion Line in the United States: 10 establishments

10 establishments in the United States are registered with the FDA to make Filter, Infusion Line (product code FPB). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Filter, Infusion Line
Product code
FPB
Country
United States

Makers of Filter, Infusion Line in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer6August 31, 2026000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer2January 11, 1990000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer2January 11, 1990000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer1December 8, 2011000api.fda.gov
Douglas Medical Products, IncMundelein, IL, United StatesComplaint file establishment, Specification developer1February 16, 1995000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1April 9, 1986000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer1March 6, 1979000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1February 27, 1979000api.fda.gov
RG Medical USAMount Juliet, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Tech Group Grand Rapids, Inc.Gr, MI, United StatesContract manufacturer0000api.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.