# Edap International Corp.

- Location (FDA's records): Burlington
- FDA decisions: 2 (1989–1991): 2 original PMA approvals
- Product codes: LNS (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Direx Systems Corp.: 1 (https://510kreport.com/company/direx-systems)
- Edap Tms France: 1 (https://510kreport.com/company/edap-tms-france)

## Its most-cited devices
- P880011: Technomed International Sonolith 2000 (1989), cited by 1
- P880042: Edap LT.01 Shock Wave Lithotripter (1991), cited by 1

## Recent decisions
- P880042: Edap LT.01 Shock Wave Lithotripter (Dec 12, 1991)
- P880011: Technomed International Sonolith 2000 (Jun 23, 1989)

Source page: https://510kreport.com/company/edap-international