FDA applicant

Cook (Canada), Inc.

L4a 7x5, Canada, CA1 decision1993–19930 recalls

FDA records 1 decision for Cook (Canada), Inc. (L4a 7x5, Canada, CA) in 1993: 1 510(k) clearance. All are in product code KPR (System, X-Ray, Stationary). 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, radiology panel, where it files most

How often FDA has decided Cook (Canada), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cook (Canada), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cook (Canada), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cook (Canada), Inc.’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 “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 Medical Incorporated 3 Cook Advanced Technologies 1 Cook Corporated 1

Cook (Canada), Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cook”