Zien Medical Technologies, Inc

FDA Regulatory Profile

Zien Medical Technologies, Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2800-2015, Class II) was initiated on August 18, 2015. Its most recent 510(k) clearance was granted on July 2, 2024.

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