FDA applicant
Adhezion Biomedical, LLC
FDA records 12 decisions for Adhezion Biomedical, LLC (Wyomissing, PA) from 2008 to 2023: 12 510(k) clearances. Most are in product codes MPN (Tissue Adhesive For The Topical Approximation…) and NZP (Sealant, Microbial). Its devices cite 25 predicates, 17 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Adhezion Biomedical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Adhezion Biomedical, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Adhezion Biomedical, LLC’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