FDA applicant

Coeur Laboratories, Inc.

Raleigh, NC10 decisions1983–19970 recalls

FDA records 10 decisions for Coeur Laboratories, Inc. (Raleigh, NC) from 1983 to 1997: 10 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and KOD (Catheter, Urological). 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 Coeur Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coeur Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Coeur Laboratories, Inc.’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 “Coeur”

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

Coeur, Inc. 14 Coeur Medical 1

Coeur Laboratories, Inc.

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 “Coeur”