Data / Medical devices / United States / Nuo Therapeutics, Inc.
Nuo Therapeutics, Inc.: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Nuo Therapeutics, Inc. is registered with the FDA (registration 3004140833) in Houston, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004140833
- Address
- 8285 El Rio Suite 190, Houston, TX, United States, 77054
- Owner or operator
- Nuo Therapeutics, Inc. (9058053)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 8, 2007
- Registered through
- 2026
- Brand names listed
- 4TR, Aurix, Aurix Multifly 4-Pack, Aurix XL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Phlebotomy Blood Collection Kit | OFM | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | 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 12, 2003 | K032150 | SAFETY-MULTIFLY | FPA | Substantially Equivalent | Sarstedt, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Phlebotomy Blood Collection Kit
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, Administration, Intravascular
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Updated September 12, 2003. 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.