Device type
Needle, Hypodermic, Single Lumen
Product code FMI · Class II · 21 CFR 880.5570 · General Hospital
Recent 510(k)s
Sep 17, 2026
K261266
MOWANA™ Auto Duo
PENTAMASTER MEDIQ SDN BHD
- FMI
- Class II
Aug 25, 2026
K261719
Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd.
- FMI
- Class II
Recent recalls
Sep 23, 2026
Z-3179-2026
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC
- FMI
- Class II
- Ongoing
Sep 23, 2026
Z-3180-2026
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC
- FMI
- Class II
- Ongoing