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Prodeon Medical, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K253525Urocross Expander System (Model Numbers ES2018 and ES3025)March 12, 2026
K252572Prodeon Urethral Sheath SystemOctober 7, 2025