Beeken Biomedical, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0309-2022Class IINuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleediOctober 14, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K183190NuStatSeptember 25, 2019
K160578Nustat XRJune 29, 2016
K142363NUSTAT, NUSTAT XRJanuary 9, 2015