510(k) Report

FDA applicant

Bio-Med Corp.

Mchenry, IL5 decisions1980–19820 recalls

FDA records 5 decisions for Bio-Med Corp. (Mchenry, IL) from 1980 to 1982: 5 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and FJI (Dialyzer, Capillary, Hollow Fiber). 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 Bio-Med Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Med Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio-Med 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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