510(k) Report

FDA applicant

Adhezion Biomedical, LLC

Wyomissing, PA12 decisions2008–20230 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Adhezion Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12009: 12013: 32014: 32015: 12016: 12017: 12023: 1
2008high 3 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Adhezion Biomedical, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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