Uromedica Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0458-2022Class IIUROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.November 22, 2021
Z-1808-2020Class IIProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisApril 10, 2019