FDA applicant
Visitec Co.
FDA records 49 decisions for Visitec Co. (Sarasota, FL) from 1979 to 1995: 49 510(k) clearances. Most are in product codes HOZ (Sponge, Ophthalmic) and HMX (Cannula, Ophthalmic). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Visitec Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Visitec Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Visitec Co.’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