Data / Medical devices / United States / Curium US LLC
Curium US LLC: FDA-registered device maker in Maryland Heights, MO, United States, 1 510(k) clearance
Curium US LLC is registered with the FDA (registration 3011353845) in Maryland Heights, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 1985. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011353845
- FEI number
- 1946929
- Address
- 2703 Wagner Pl, Maryland Heights, MO, United States, 63043
- Owner or operator
- Curium US LLC (10051585)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 7, 2016
- Registered through
- 2027
- Brand names listed
- Xenotron Xenon (Xe 133) Gas Dispenser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Rebreathing, Radionuclide | IYT | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 14, 1985 | K843640 | XENON XE 127/XE 133 GAS DISPENSER | IYT | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
Compare with other makers
Updated January 14, 1985. 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.