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Data / Medical devices / Catheter, Hemodialysis, Implanted / United States

FDA-registered makers of Catheter, Hemodialysis, Implanted in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Catheter, Hemodialysis, Implanted (product code MSD). 12 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Hemodialysis, Implanted
Product code
MSD
Country
United States

Makers of Catheter, Hemodialysis, Implanted in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer22September 14, 2021050api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Manufacturer, Specification developer13March 5, 2020010api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer10July 7, 2014030api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler10July 7, 2014000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer8January 31, 2013031api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer8January 31, 2013010api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer7April 4, 2016011api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesManufacturer6July 1, 2021020api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler2May 16, 2025000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer1November 18, 2010010api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer1May 16, 2025000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer1January 9, 2014000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Nuwellis, Inc.Eden Prairie, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Point Medical Corp.Crown Point, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, 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.