FDA applicant
Jedmed Instrument Co.
FDA records 93 decisions for Jedmed Instrument Co. (Mchenry, IL) from 1979 to 2015: 93 510(k) clearances. Most are in product codes ETF (Unit, Examining/Treatment, Ent) and DZI (Drill, Bone, Powered). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Jedmed Instrument Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jedmed Instrument Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Jedmed Instrument 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