FDA applicant

Cordis Europa, N.V.

Warren, NJ7 decisions2001–20071 recall

FDA records 7 decisions for Cordis Europa, N.V. (Warren, NJ) from 2001 to 2007: 7 510(k) clearances. Most are in product codes KNQ (Dilator, Esophageal) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 13 predicates, 2 of them its own earlier devices. 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Cordis Europa, N.V.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cordis Europa, N.V.’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 “Cordis”

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

Cordis Corp. 334 Cordis Neurovascular, Inc. 38 Cordis US Corporation 12 Cordis Corp., A Johnson & Johnson Co. 11 Cordis Webster, Inc. 10 Cordis Leads, Inc. 4 Cordis, A Cardinal Health Company 1

Cordis Europa, N.V.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cordis”