Data / Medical devices / Catheter, Hemodialysis, Non-Implanted / United States
FDA-registered makers of Catheter, Hemodialysis, Non-Implanted in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Catheter, Hemodialysis, Non-Implanted (product code MPB). 10 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Hemodialysis, Non-Implanted
- Product code
- MPB
- Country
- United States
Makers of Catheter, Hemodialysis, Non-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 | 6 | August 12, 2025 | 0 | 1 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 4 | January 17, 2020 | 0 | 2 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 4 | January 17, 2020 | 0 | 1 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 3 | September 14, 2000 | 0 | 4 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 3 | February 12, 2009 | 0 | 2 | 1 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 3 | September 14, 2000 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 2 | January 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 1 | November 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 1 | December 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | November 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Kluge Design Inc. | Rogers, MN, 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 | |
| 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.