Prodeon Medical, Inc.

FDA Regulatory Profile

Prodeon Medical, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 22, 2026.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K261342Urocross Expander System (UES-2018-C1)June 22, 2026
K253525Urocross Expander System (Model Numbers ES2018 and ES3025)March 12, 2026
K252572Prodeon Urethral Sheath SystemOctober 7, 2025