# Mdi Instruments, Inc.

- Location (FDA's records): Woburn, MA
- FDA decisions: 2 (1997–1997): 2 510(k) clearances
- Product codes: ETY (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K970685: Earcheck Pro (1997), cited by 1

## Recent decisions
- K971859: Earcheck (Aug 18, 1997)
- K970685: Earcheck Pro (May 28, 1997)

Source page: https://510kreport.com/company/mdi-instruments