FDA applicant
Marizyme, Inc.
FDA records 2 decisions for Marizyme, Inc. (Jupiter, FL) from 2023 to 2024: 1 510(k) clearance and 1 De Novo grant. All are in product code QEJ (Flushing Solution For Short Term Storage Of…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Marizyme”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Marizyme, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Marizyme, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report