510(k) Report

FDA applicant

Medelco, Ltd.

Mchenry, IL4 decisions1983–19850 recalls

FDA records 4 decisions for Medelco, Ltd. (Mchenry, IL) from 1983 to 1985: 4 510(k) clearances. Most are in product codes JES (Floss, Dental) and IPF (Stimulator, Muscle, Powered). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Medelco, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medelco, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medelco, Ltd.’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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