Data / Medical devices / United States / Novex Innovations, LLC
Novex Innovations, LLC: FDA-registered device maker in Winston Salem, NC, United States, 1 510(k) clearance
Novex Innovations, LLC is registered with the FDA (registration 3011680766) in Winston Salem, NC, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011680766
- Address
- 101 N Chestnut ST Ste 308, Winston Salem, NC, United States, 27101
- Owner or operator
- Novex Innovations (10049549)
- Roles
- Manufacturer
- First device listed
- June 17, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Hot/Cold Water | FPF | 1 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Ac-Powered, Ophthalmic | HPL | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 19, 2024 | K232204 | ReyaGel (RG03 - MTP gel 3mL) | KGN | Substantially Equivalent | Fettech | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Fixation, Ac-Powered, Ophthalmic
- All makers of Bottle, Hot/Cold Water
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated April 19, 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.