# Boule Medical AB

- Location (FDA's records): Plantation, FL
- FDA decisions: 2 (2004–2009): 2 510(k) clearances
- Product codes: GKZ (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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K083420: Medonic M Series (Feb 3, 2009)
- K032214: Medonic CA620/530 Hematology Analyzer (Jan 29, 2004)

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