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Prodeon Medical, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Urocross Expander System (UES-2018-C1)510(k)Jun 22, 2026Gastroenterology, Urology
Urocross Expander System (Model Numbers ES2018 and ES3025)510(k)Mar 12, 2026Gastroenterology, Urology
Prodeon Urethral Sheath System510(k)Oct 7, 2025Gastroenterology, Urology

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