# Higia., Inc. d/b/a Eden

- Location (FDA's records): Wilmington, DE
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: LLZ (1)
- 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
- K261788: Eden PACS (Oct 21, 2026)

Source page: https://510kreport.com/company/higia-d-b-a-eden