SMITH & NEPHEW CDS SYSTEM— 510(k) K081491

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K081491 for SMITH & NEPHEW CDS SYSTEM, Substantially Equivalent on 2008-06-19. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2008-05-28
Decision date: 2008-06-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.