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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 22 | September 14, 2021 | 0 | 5 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer, Specification developer | 13 | March 5, 2020 | 0 | 1 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 10 | July 7, 2014 | 0 | 3 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 10 | July 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 8 | January 31, 2013 | 0 | 3 | 1 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 8 | January 31, 2013 | 0 | 1 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Specification developer | 7 | April 4, 2016 | 0 | 1 | 1 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Manufacturer | 6 | July 1, 2021 | 0 | 2 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 2 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer | 1 | November 18, 2010 | 0 | 1 | 0 | api.fda.gov |
| Haolang Medical Usa Corporation | Clyde Hill, WA, United States | Specification developer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 1 | January 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuwellis, Inc. | Eden Prairie, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Point Medical Corp. | Crown Point, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract 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.