Carl Zeiss Suzhou Co., Ltd.

FDA Regulatory Profile

Carl Zeiss Suzhou Co., Ltd. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0183-2024, Class II) was initiated on August 18, 2023. Its most recent 510(k) clearance was granted on May 3, 2018.

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