# Marizyme, Inc.

- Location (FDA's records): Jupiter, FL
- FDA decisions: 2 (2023–2024): 1 510(k) clearance and 1 De Novo grant
- Names in FDA's records: Marizyme, Inc. (1); Marizyme (1)
- Product codes: QEJ (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN230002: DuraGraft (2023), cited by 1

## Recent decisions
- K240925: DuraGraft Vascular Conduit Solution (May 1, 2024)
- DEN230002: DuraGraft (Oct 4, 2023)

Source page: https://510kreport.com/company/marizyme