FDA applicant
Optmed, Inc.
FDA records 3 decisions for Optmed, Inc. (New York, NY) from 2015 to 2025: 3 510(k) clearances. Most are in product codes MPN (Tissue Adhesive For The Topical Approximation…) and KMF (Bandage, Liquid). Its devices cite 5 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 Optmed, 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 2015.
Planning a device like Optmed, 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