# Edgewater Medical Systems, Inc.

- Location (FDA's records): Mayfield Hts., OH
- FDA decisions: 2 (1988–1988): 2 510(k) clearances
- Product codes: BTX (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K884838: Allen Prone Armboard (Dec 15, 1988)
- K881292: Allen Lateral Armboard (Apr 7, 1988)

Source page: https://510kreport.com/company/edgewater-medical-systems