# Ofi Biomedica S.P.A.

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 1 (2001–2001): 1 510(k) clearance
- Product codes: FIB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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
- Jms North America Corp.: 1 (https://510kreport.com/company/jms-north-america)

## Its most-cited devices
- K001971: Hemodialysis Tubing Sets (2001), cited by 1

## Recent decisions
- K001971: Hemodialysis Tubing Sets (May 24, 2001)

Source page: https://510kreport.com/company/ofi-biomedica