FDA applicant

Tpl-Cordis, Inc.

Suffield, CT6 decisions1987–19890 recalls

FDA records 6 decisions for Tpl-Cordis, Inc. (Suffield, CT) from 1987 to 1989: 6 510(k) clearances. 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 Tpl-Cordis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tpl-Cordis, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tpl-Cordis, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tpl-Cordis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Tpl-Cordis, Inc.

Which product codes does it file in?

What has FDA decided for it lately?