510(k) Report

FDA applicant

Bio-Medical Systems Corp.

Mchenry, IL4 decisions1978–19790 recalls

FDA records 4 decisions for Bio-Medical Systems Corp. (Mchenry, IL) from 1978 to 1979: 4 510(k) clearances. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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, neurology panel, where it files most

How often FDA has decided Bio-Medical Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Medical Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Medical Systems Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio-Medical Systems Corp.’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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