Medical Device Manufacturer · IL , Ra?Anana

Urogen Pharma, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Total

Cleared

Denied

Urogen Pharma, Ltd. has 5 FDA 510(k) cleared medical devices. Based in Ra?Anana, IL.

Last cleared in 2021. Active since 2018. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Urogen Pharma, Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Urogen Pharma, Inc. and Urogen Pharma.

Urogen Pharma, Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Urogen Pharma, Ltd.

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 22, 2026