FDA applicant

Cortex Biophysik GmbH

Appollo Beach, FL2 decisions2000–20010 recalls

FDA records 2 decisions for Cortex Biophysik GmbH (Appollo Beach, FL) from 2000 to 2001: 2 510(k) clearances. Most are in product codes BZC (Calculator, Pulmonary Function Data) and BTY (Calculator, Predicted Values, Pulmonary Function). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Cortex Biophysik GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cortex Biophysik GmbH 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.

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

Cortex Biophysik GmbH

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”