Urogen Pharma, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrNovember 19, 2021
K203321Cystoject Syringe LeverDecember 9, 2020
K190987Uroject12 Syringe LeverDecember 2, 2019
K180354UroGen Ureteral CatheterOctober 30, 2018
K180345Uroject12 Syringe LeverOctober 17, 2018