FDA applicant

Winfield Co., Inc.

Brentwood, TN5 decisions1980–19940 recalls

FDA records 5 decisions for Winfield Co., Inc. (Brentwood, TN) from 1980 to 1994: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and LYY (Latex Patient Examination Glove). 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 hospital panel, where it files most

How often FDA has decided Winfield Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Winfield Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Winfield 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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Other applicant names beginning “Winfield”

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

Winfield Laboratories, Inc. 4 Winfield Industries 3

Winfield Co., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Winfield”