FDA applicant

Cortex Technology Aps

Washington, DC2 decisions1998–19990 recalls

FDA records 2 decisions for Cortex Technology Aps (Washington, DC) from 1998 to 1999: 2 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Cortex Technology Aps since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cortex Technology Aps’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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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, Inc. 2 Cortex Biophysik GmbH 2 Cortex Research Corp. 1

Cortex Technology Aps

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cortex”