1BD SOLOSHOT IX SYRINGE— 510(k) K042934

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K042934 for 1BD SOLOSHOT IX SYRINGE, Substantially Equivalent on 2004-10-28. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2004-10-25
Decision date: 2004-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.