# Corneagen, Inc.

- Location (FDA's records): Winston-Salem, NC
- FDA decisions: 2 (2015–2022): 1 510(k) clearance and 1 original PMA approval
- Names in FDA's records: Corneagen, Inc. (1); Corneagen (1)
- Product codes: OTZ (1), LQE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tdak Medical, Inc.: 1 (https://510kreport.com/company/tdak-medical)

## Recent decisions
- K203586: EndoSerter-PL (Feb 2, 2022)
- P120023: Kamra Inlay (Apr 17, 2015)

Source page: https://510kreport.com/company/corneagen