FDA applicant
Kosan Far East Ent., Ltd.
FDA records 2 decisions for Kosan Far East Ent., Ltd. (Hong Kong, TW) in 1989: 2 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and EYC (Catheter, Upper Urinary Tract). 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 Kosan Far East Ent., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kosan Far East Ent., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kosan Far East Ent., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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