FDA applicant
MLM Biologics, Inc.
FDA records 2 decisions for MLM Biologics, Inc. (Alachua, FL) from 2014 to 2026: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided MLM Biologics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like MLM Biologics, 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