Beeken Biomedical, LLC

FDA Regulatory Profile

Beeken Biomedical, LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0309-2022, Class II) was initiated on October 14, 2021. Its most recent 510(k) clearance was granted on September 25, 2019.

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