FDA applicant
Bionova Medical, Inc.
FDA records 6 decisions for Bionova Medical, Inc. (Germantown, TN) from 2012 to 2024: 6 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 255 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 6 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 Bionova Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Bionova Medical, 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