FDA applicant
Aomori Olympus Co., Ltd.
FDA records 7 decisions for Aomori Olympus Co., Ltd. (Melville, NY) from 2003 to 2005: 7 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 26 predicates, 4 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 Aomori Olympus Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Aomori Olympus Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aomori 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.
See the 510(k) Report