FDA applicant

Cordis US Corporation

Miami Lakes12 decisions1991–202412 recalls

FDA records 12 decisions for Cordis US Corporation (Miami Lakes) from 1991 to 2024: 4 510(k) clearances and 8 original PMA approvals. Most are in product codes MGB (Device, Hemostasis, Vascular) and NIN (Stent, Renal). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. 12 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Cordis US Corp”.

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 Cordis US Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 3 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cordis US Corporation’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 “Cordis”

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

Cordis Corp. 334 Cordis Neurovascular, Inc. 38 Cordis Corp., A Johnson & Johnson Co. 11 Cordis Webster, Inc. 10 Cordis Europa, N.V. 7 Cordis Leads, Inc. 4 Cordis, A Cardinal Health Company 1

Cordis US Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cordis”