Data / Medical devices / Oximeter, Reprocessed
Oximeter, Reprocessed (NLF): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Oximeter, Reprocessed (product code NLF, Class 2, 21 CFR 870.2700). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on October 22, 2024, and lists 1 recall event (0 Class I). 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.
- Product code
- NLF
- Device class
- 2
- Regulation
- 870.2700
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 3 |
Makers of Oximeter, Reprocessed
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions | Tempe, AZ, United States | Reprocessor, Specification developer | 6 | October 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 6 | October 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Stryker Tijuana Operations | Tijuana Baja California, Mexico | Reprocessor | 6 | October 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Renu Medical, Inc. | Everett, WA, United States | Complaint file establishment, Repackager or relabeler, Reprocessor | 4 | November 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 2 | July 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Reprocessor | 1 | December 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | December 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 1 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | July 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 22, 2024. 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.