510(k) Report

FDA applicant

Cortex Research Corp.

Walker, MI1 decision1980–19800 recalls

FDA records 1 decision for Cortex Research Corp. (Walker, MI) in 1980: 1 510(k) clearance. All are in product code GLE (Mixer, Blood Tube). 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, clinical chemistry panel, where it files most

How often FDA has decided Cortex Research Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cortex Research Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cortex”

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