FDA applicant

Cook Pacemaker Corp.

Leechburg, PA35 decisions1981–19970 recalls

FDA records 35 decisions for Cook Pacemaker Corp. (Leechburg, PA) from 1981 to 1997: 34 510(k) clearances and 1 original PMA approval. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTB (Permanent Pacemaker Electrode). 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 Cook Pacemaker Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cook Pacemaker Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cook Pacemaker Corp.’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 Vascular, Inc. 12 Cook Endoscopy 5 Cook Biotech Incorprated 4 Cook Medical Incorporated 3 Cook (Canada), Inc. 1 Cook Advanced Technologies 1 Cook Corporated 1

Cook Pacemaker Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cook”