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Cogentix Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
7
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253905PrimeSight UltraView SystemApril 7, 2026
K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorNovember 15, 2018