FDA applicant

Smith and Nephew Medical Limited

Hull, GB2 decisions2021–20230 recalls

FDA records 2 decisions for Smith and Nephew Medical Limited (Hull, GB) from 2021 to 2023: 2 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and QFC (Negative Pressure Wound Therapy Device For…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 and Nephew Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Smith and Nephew Medical Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Smith and Nephew Medical Limited’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 “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 United, Inc. 34 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 Medical Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Smith”