FDA applicant
Maxigen Biotech, Inc.
FDA records 5 decisions for Maxigen Biotech, Inc. (Taoyuan, TW) from 2011 to 2026: 5 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and OLR (Oral Wound Dressing). Since 2016 its 510(k)s took a median of 373 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Maxigen Biotech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Maxigen Biotech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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