# Edge Medical, LLC

- Location (FDA's records): Lutsen, MN
- FDA decisions: 1 (2014–2014): 1 510(k) clearance
- Product codes: PCT (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: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radiadyne: 1 (https://510kreport.com/company/radiadyne)

## Recent decisions
- K141958: Erb Endorectal Balloon (Nov 18, 2014)

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