FDA applicant

Cortex, Inc.

Santa Clara, CA2 decisions2026–20260 recalls

FDA records 2 decisions for Cortex, Inc. (Santa Clara, CA) in 2026: 2 510(k) clearances. All are in product code MTD (Catheter, Intracardiac Mapping, High-Density…). Its devices cite 2 predicates, 1 of them its own earlier devices. 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 Cortex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Cortex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Cortex”

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

Cortex Dental Implants Industries, Ltd. 4 Cortex Manufacturing, Inc. 3 Cortex Biophysik GmbH 2 Cortex Technology Aps 2 Cortex Research Corp. 1

Cortex, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cortex”