Zien Medical Technologies, Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2800-2015Class IIPenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and cAugust 18, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K240915ZIEN IO Intraosseous Access SystemJuly 2, 2024
K214060LANDMARK REBOA CatheterSeptember 19, 2022