# Mondeal North America, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: OCZ (1)
- Predicates its devices cite: 3 (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
- Instratek, Inc.: 2 (https://510kreport.com/company/instratek)
- A.M. Surgical, Inc.: 1 (https://510kreport.com/company/am-surgical)

## Recent decisions
- K072684: Mondeal Endoscopic Tissue Recession and Release System (Jan 4, 2008)

Source page: https://510kreport.com/company/mondeal-north-america