FDA applicant

Cook Medical Incorporated

Bjaeverskov3 decisions2011–20243 recalls

FDA records 3 decisions for Cook Medical Incorporated (Bjaeverskov) from 2011 to 2024: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes MIH (System, Endovascular Graft, Aortic Aneurysm…) and DYB (Introducer, Catheter). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Cook Medical”.

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 Cook Medical Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2025

2011high 1 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Cook Medical Incorporated by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cook”

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

Cook, Inc. 371 Cook Urological, Inc. 104 Cook Biotech, Inc. 47 Cook Ob/Gyn 43 Cook Ireland, Ltd. 37 Cook Pacemaker Corp. 35 Cook Vascular, Inc. 12 Cook Endoscopy 5 Cook Biotech Incorprated 4 Cook (Canada), Inc. 1 Cook Advanced Technologies 1 Cook Corporated 1

Cook Medical Incorporated

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cook”