FDA.reportPublic FDA data

UROGEN PHARMA LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30130241913013024191UROGEN PHARMA LTD.1N2026-01-019 Ha'Ta'asiya Street Ra'anana Central IL 4365007

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2119781572687993K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD2021-11-19
2119781044191664K180354UroGen Ureteral CatheterKOD2018-10-30
2119781265879449K180345Uroject12 Syringe LeverQBL2018-10-17
2119781236808138
2119781784322704

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KOD22021-11-19
QBL12018-10-17

PMN#