FDA applicant

Smith Assoc.

Crofton, MD1 decision1997–19970 recalls

FDA records 1 decision for Smith Assoc. (Crofton, MD) in 1997: 1 510(k) clearance. All are in product code KZD (Infusor, Pressure, For I.V. Bags). 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 Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smith Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smith Assoc. 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 Assoc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Smith”