FDA applicant

Smith & Nephew United, Inc.

Largo, FL34 decisions1989–19960 recalls

FDA records 34 decisions for Smith & Nephew United, Inc. (Largo, FL) from 1989 to 1996: 34 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and KGX (Tape And Bandage, Adhesive). 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 and plastic surgery panel, where it files most

How often FDA has decided Smith & Nephew United, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smith & Nephew United, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Smith”

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

Smith & Nephew, Inc. 556 Smith & Nephew Richards, Inc. 88 Smith & Nephew Medical Limited 33 Smith & Nephew Dyonics, Inc. 22 Smith & Nephew Endoscopy, Inc. 18 Smith and Nephew Donjoy, Inc. 15 Smith River Biologicals 12 Smith & Nephew, Inc., Orthopaedic Div. 10 Smith & Nephew Perry 10 Smith & Nephew Inc., Endoscopy Div. 10 Smith & Nephew, Mpl Division 9 Smith and Nephew, Inc. 8

Smith & Nephew United, 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 “Smith”