FDA applicant
Olympus America, Inc.
FDA records 149 decisions for Olympus America, Inc. (Melville, NY) from 1994 to 2012: 149 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 88 predicates, 36 of them its own earlier devices. 71 recalls are linked to its devices, 2 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
13in 2026
Class I Class II/III not classified
Planning a device like Olympus America, Inc.’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.