510(k) Report

FDA applicant

Jedmed Instrument Co.

Mchenry, IL93 decisions1979–20151 recall

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, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Jedmed Instrument Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Jedmed Instrument Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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