Data / Medical devices / United States / Fresenius USA Manufacturing, Inc.
Fresenius USA Manufacturing, Inc.: FDA-registered device maker in Ogden, UT, United States, 3 510(k) clearances
Fresenius USA Manufacturing, Inc. is registered with the FDA (registration 1713747) in Ogden, UT, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1713747
- Address
- 475 West 13TH ST., Ogden, UT, United States, 84404
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Manufacturer
- First device listed
- May 9, 2017
- Registered through
- 2026
- Brand names listed
- Hemoflow F3 Dialyzer, Hemoflow F4 Dialyzer, Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers, Optiflux F180NR Dialyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, Capillary, Hollow Fiber | FJI | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2020 | K192707 | Optiflux F180NR Dialyzer | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| August 23, 2019 | K190459 | Hemoflow F3 and F4 Dialyzers | FJI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 6, 2017 | K162488 | Optiflux dialyzer | KDI | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, Capillary, Hollow Fiber
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
Updated September 21, 2020. 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.