FDA applicant
Downs Surgical, Ltd.
FDA records 60 decisions for Downs Surgical, Ltd. (Sheffield S9 4wj, GB) from 1980 to 1990: 60 510(k) clearances. Most are in product codes HRX (Arthroscope) and GDM (Needle, Aspiration And Injection, Reusable). 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 Downs Surgical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Downs Surgical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Downs Surgical, 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