FDA applicant
Abbott Medical Optics, Inc.
FDA records 16 decisions for Abbott Medical Optics, Inc. (Santa Ana, CA) from 1989 to 2017: 13 510(k) clearances and 3 original PMA approvals. Most are in product codes HQC (Unit, Phacofragmentation) and LPN (Accessories, Soft Lens Products). Its devices cite 21 predicates, 6 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Medical Optics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Abbott Medical Optics, 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 “Abbott”
FDA records each applicant name separately; these may or may not be the same firm.