FDA applicant

Covidien (Part of Medtronic)

North Haven, CT2 decisions2024–20260 recalls

FDA records 2 decisions for Covidien (Part of Medtronic) (North Haven, CT) from 2024 to 2026: 2 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and GAG (Stapler, Surgical). Its devices cite 6 predicates, 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, general and plastic surgery panel, where it files most

How often FDA has decided Covidien (Part of Medtronic)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Covidien (Part of Medtronic) by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Covidien (Part of Medtronic)’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

Other applicant names beginning “Covidien”

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

Covidien 227 Covidien, Formerly US Surgical A Divison of Tyco H 13 Covidien Lp, Formerly Registered AS United States 8 Covidien, Formerly Valleylab, A Division of Tyco H 6 Covidien, Formerly Nellcor Puritan Bennett, Inc. 5 Covidien Lp, Formerly Registered AS Tyco Healthcar 4 Covidien Lp, Formerly Registered AS Kendall 3 Covidien, LLC ( Formerly Beacon Endoscopic Corp.) 2 Covidien, LLC, Formerly Registered AS Tyco Healthca 2 Covidien Lp, Formerly Know AS Valleylab, A Divison 2 Covidien (Dba Medtronic) 1 Covidien UK Manufacturing, Ltd. 1

Covidien (Part of Medtronic)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Covidien”