Phenox, Ltd. 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	What it is	Route	Decided
Esperance pHLO Aspiration System510(k)Jan 15, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 15, 2026
pNOVUS 21 Microcatheter510(k)Nov 12, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 12, 2024
pNOVUS 21 Microcatheter510(k)Nov 28, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 28, 2022