FDA applicant

Smith and Nephew Donjoy, Inc.

Carsbad, CA15 decisions1991–19970 recalls

FDA records 15 decisions for Smith and Nephew Donjoy, Inc. (Carsbad, CA) from 1991 to 1997: 15 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Smith and Nephew Donjoy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smith and Nephew Donjoy, 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 United, Inc. 34 Smith & Nephew Medical Limited 33 Smith & Nephew Dyonics, Inc. 22 Smith & Nephew Endoscopy, Inc. 18 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 and Nephew Donjoy, 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”