Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Urogen Pharma, Ltd.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest Approval2021-11-19
TypeNumberDevice NameCodeDate
510(k) K211032 Urinary Catheter 12 Fr, Urinary Catheter 16 Fr KOD 2021-11-19 View
510(k) K203321 Cystoject Syringe Lever QBL 2020-12-09 View
510(k) K190987 Uroject12 Syringe Lever QBL 2019-12-02 View
510(k) K180354 UroGen Ureteral Catheter KOD 2018-10-30 View
510(k) K180345 Uroject12 Syringe Lever QBL 2018-10-17 View