FDA applicant
Jelenko Co.
FDA records 12 decisions for Jelenko Co. (Armonk, NY) from 1988 to 2001: 12 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) 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 Jelenko Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Jelenko Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Jelenko 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