MEDI PEN NEEDLE— 510(k) K131954

Substantially Equivalent

Shanghai Carelife International Trading Co. , Ltd.

FDA 510(k) clearance K131954 for MEDI PEN NEEDLE, Substantially Equivalent on 2014-05-29. Applicant: Shanghai Carelife International Trading Co. , Ltd..

Clearance details

Applicant: Shanghai Carelife International Trading Co. , Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2013-06-27
Decision date: 2014-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, Pudong, CN

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.