FDA applicant

Smith

Crofton, MD5 decisions1997–19980 recalls

FDA records 5 decisions for Smith (Crofton, MD) from 1997 to 1998: 5 510(k) clearances. Most are in product codes EWO (Audiometer) and FMQ (Restraint, Protective). 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 Smith’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smith since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smith 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 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

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Smith”