510(k) Report

FDA applicant

E.I. Dupont DE Nemours & Co., Inc.

Wilmington, DE253 decisions1976–199612 recalls

FDA records 253 decisions for E.I. Dupont DE Nemours & Co., Inc. (Wilmington, DE) from 1976 to 1996: 253 510(k) clearances. Most are in product codes DLJ (Calibrators, Drug Specific) and EAM (Screen, Intensifying, Radiographic). 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided E.I. Dupont DE Nemours & Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E.I. Dupont DE Nemours & Co., Inc. since 2007.

Recalls per year

1in 2022

2010: 12011: 22013: 12014: 12015: 12016: 12017: 12022: 1
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — E.I. Dupont DE Nemours & Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like E.I. Dupont DE Nemours & Co., 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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