AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE— 510(k) K031394

Substantially Equivalent

American Syringe Company

FDA 510(k) clearance K031394 for AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE, Substantially Equivalent on 2003-07-25. Applicant: American Syringe Company.

Clearance details

Applicant: American Syringe Company
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2003-05-02
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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.