Data / Medical devices / United States / Steriatrics Usa, LLC
Steriatrics Usa, LLC: FDA-registered device maker in Oak Ridge, NJ, United States, 1 510(k) clearance
Steriatrics Usa, LLC is registered with the FDA (registration 3013413516) in Oak Ridge, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013413516
- Address
- 5470 Berkshire Valley Rd, Oak Ridge, NJ, United States, 07438
- Owner or operator
- Steriatrics USA, LLC (10096101)
- Roles
- Specification developer
- First device listed
- July 9, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | 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 |
|---|---|---|---|---|---|---|
| December 12, 2017 | K170279 | Disposable High Pressure Syringe | DXT | Substantially Equivalent | Union Medical Shenzhen Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2017. 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.