FDA applicant
Unitek Corp.
FDA records 23 decisions for Unitek Corp. (Monrovia, CA) from 1980 to 1994: 23 510(k) clearances. Most are in product codes EJF (Bracket, Metal, Orthodontic) and EJS (Alloy, Other Noble Metal). 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 Unitek Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Unitek Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Unitek Corp.’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