FDA applicant
American Medical Systems, Inc.
FDA records 83 decisions for American Medical Systems, Inc. (Minnetonka, MN) from 1979 to 2014: 82 510(k) clearances and 1 original PMA approval. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and OTP (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 109 predicates, 83 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “American Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like American Medical Systems, 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