FDA applicant
G.W.B. Intl., Ltd.
FDA records 8 decisions for G.W.B. Intl., Ltd. (Sudbury, MA) from 1990 to 1996: 8 510(k) clearances. Most are in product codes OKS (Lacrimal Stents And Intubation Sets) and LZU (Plug, Punctum). 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 G.W.B. Intl., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for G.W.B. Intl., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like G.W.B. Intl., 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