EZ-IO Intraosseous Vascular Access System— 510(k) K231924

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K231924 for EZ-IO Intraosseous Vascular Access System, Substantially Equivalent on 2023-07-25. Applicant: Teleflex Medical.

Clearance details

Applicant: Teleflex Medical
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2023-06-30
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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.