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Carl Zeiss Suzhou Co., Ltd.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0183-2024Class IIOPMI LUMERA 300, REF 6137August 18, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K171007Fluorescence ModeMay 3, 2018
K163195PRIMUSJune 21, 2017