K211634

Substantially Equivalent

Hypodermic Needle-Pro EDGE Safety Device

Applicant: Smiths Medical Asd, Inc.
Product code: FMI
Advisory panel: General Hospital
Date received: 2021-05-27
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.