FDA applicant
J.F. Jelenko & Co., Inc.
FDA records 56 decisions for J.F. Jelenko & Co., Inc. (Armonk, NY) from 1988 to 2001: 56 510(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.
FDA’s records also spell it “J.F. Jelenko & Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided J.F. Jelenko & Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for J.F. Jelenko & Co., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like J.F. Jelenko & Co., 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) Report