510(k) Report

FDA applicant

Bomed Medical Mfr., Ltd.

Mchenry, IL8 decisions1981–19860 recalls

FDA records 8 decisions for Bomed Medical Mfr., Ltd. (Mchenry, IL) from 1981 to 1986: 8 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Bomed Medical Mfr., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bomed”

FDA records each applicant name separately; these may or may not be the same firm.