FDA applicant
Proxy Biomedical, Ltd.
FDA records 6 decisions for Proxy Biomedical, Ltd. (Stillwater, MN) from 2005 to 2018: 6 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and OTO (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 3 predicates, 3 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 Proxy Biomedical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Proxy Biomedical, Ltd.’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