JMS SYRINGE— 510(k) K132321

Substantially Equivalent

JMS North America Corporation

FDA 510(k) clearance K132321 for JMS SYRINGE, Substantially Equivalent on 2014-02-20. Applicant: JMS North America Corporation.

Clearance details

Applicant: JMS North America Corporation
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2013-07-25
Decision date: 2014-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, 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.