FDA applicant
Marco Ophthalmic, Inc.
FDA records 15 decisions for Marco Ophthalmic, Inc. (Jacksonville, FL) from 1992 to 1994: 15 510(k) clearances. Most are in product codes HLM (Instrument, Measuring, Lens, Ac-Powered) and HME (Chair, Ophthalmic, Ac-Powered). 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 Marco Ophthalmic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Marco Ophthalmic, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Marco Ophthalmic, 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 “Marco”
FDA records each applicant name separately; these may or may not be the same firm.