FDA applicant
Aizu Olympus Co., Ltd.
FDA records 1 decision for Aizu Olympus Co., Ltd. (Melville, NY) in 2005: 1 510(k) clearance. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 1 predicate, 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 Aizu Olympus Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Aizu Olympus Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aizu Olympus Co., 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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