Fresenius USA Manufacturing, Inc.
Irving, TX, US
Fresenius USA Manufacturing, Inc. appears in FDA device records in Irving, TX. FDA records list no 510(k) clearances, no PMA records and 9 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 9
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1651896 | 3003310249 | Fresenius USA Manufacturing, Inc. | 5201 Regent Blvd, IRVING, TX 75063 US | 2026 | |
| 1713747 | 1713747 | Fresenius USA Manufacturing, Inc. | 475 WEST 13TH ST., Ogden, UT 84404 US | 2026 | |
| 3005162618 | 1527681 | Fresenius USA Manufacturing, Inc. | 750 North Lallendorf Rd, OREGON, OH 43616 US | 2026 | |
| 3009242923 | 3009242923 | Fresenius USA Manufacturing, Inc. | 371 S. Royal Lane, DFW Airport, TX 75261 US | 2026 | No device listings on this registration |
| 3010039371 | 3010039371 | Fresenius USA Manufacturing, Inc. | 555 Blue Heron Dr, Oregon, OH 43616 US | 2026 | No device listings on this registration |
| 3012417381 | 3012417381 | Fresenius USA Manufacturing, Inc. | 2865 DAVE LYLE BLVD, Rock Hill, SC 29730 US | 2026 | No device listings on this registration |
| 3012786295 | 3012786295 | Fresenius USA Manufacturing, Inc. | 69 Tetz Rd, Suite 2A, Chester, NY 10918 US | 2026 | No device listings on this registration |
| 3013546115 | 3013546115 | Fresenius USA Manufacturing, Inc. | 5105 South National Drive, Knoxville, TN 37914 US | 2026 | |
| 3017125096 | 3017125096 | Fresenius USA Manufacturing, Inc. | 5304 East Governor John Sevier Highway, Knoxville, TN 37914 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- NIIDisinfectant, Dialysate Delivery System
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FIPSubsystem, Water Purification
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Fresenius USA Manufacturing, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain