FDA applicant
Olympus Optical Co., Ltd.
FDA records 48 decisions for Olympus Optical Co., Ltd. (Melville, NY) from 1996 to 2003: 48 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 106 predicates, 21 of them its own earlier devices. 67 recalls are linked to its devices, 15 Class I.
FDA’s records also spell it “The Olympus Optical Co.”, “Olympus Optical, Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Optical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Olympus Optical Co., Ltd. since 2007.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Olympus Optical 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) ReportOther applicant names beginning “Olympus”
FDA records each applicant name separately; these may or may not be the same firm.