FDA applicant
Fomed Industries, Inc.
FDA records 2 decisions for Fomed Industries, Inc. (Qian Jing City, CN) from 2022 to 2025: 2 510(k) clearances. Most are in product codes PEM (Dental Barriers And Sleeves) and FXX (Mask, Surgical). Its devices cite 2 predicates, 0 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 Fomed Industries, 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 2022.
Planning a device like Fomed Industries, 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