Uromedica Inc.

FDA Regulatory Profile

Uromedica Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0458-2022, Class II) was initiated on November 22, 2021.

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