# Bernafon-Maico, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 9 (1996–1998): 9 510(k) clearances
- Product codes: ESD (5), EWO (4)
- 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
- K982723: Maico MA42 (Oct 28, 1998)
- K981142: Maico MA53 (Apr 22, 1998)
- K974211: Opus 2 - Full Concha Series - Ite (Dec 15, 1997)
- K974152: Opus 2 - Completely-in-Canal Series (Cic) (Dec 15, 1997)
- K974069: Opus 2 - Canal Series (Itc) (Dec 15, 1997)
- K973948: Dualine 100 Bte (Oct 28, 1997)
- K971158: Dualine 400 Cic (Jun 13, 1997)
- K971080: Maico MA52 (Jun 6, 1997)

Source page: https://510kreport.com/company/bernafon-maico