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Elucent Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0806-2025Class IIEnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The November 18, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K233639SmartClip Secure Soft Tissue MarkerDecember 20, 2024
K183400EnVisio Navigation SytemMarch 22, 2019
K180640SmartClip Soft Tissue MarkerJune 4, 2018