Data / Medical devices / System, Rebreathing, Radionuclide / United States
FDA-registered makers of System, Rebreathing, Radionuclide in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make System, Rebreathing, Radionuclide (product code IYT). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Rebreathing, Radionuclide
- Product code
- IYT
- Country
- United States
Makers of System, Rebreathing, Radionuclide in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medi Nuclear Corp., Inc. | Baldwin Park, CA, United States | Manufacturer | 2 | October 20, 1987 | 0 | 0 | 0 | api.fda.gov |
| Curium US LLC | Maryland Heights, MO, United States | Complaint file establishment, Specification developer | 1 | January 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler | 1 | November 3, 1995 | 0 | 0 | 0 | api.fda.gov |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 1 | April 11, 1988 | 0 | 0 | 0 | api.fda.gov |
| Radnostix | Idaho Falls, ID, United States | Specification developer | 1 | October 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | March 2, 1982 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tricor Systems | Elgin, IL, 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.