Mauna Kea Technologies FDA Approvals

0 new drug approvals and 2 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
Cellvizio 100 series system with confocal Miniprobes510(k)Apr 11, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 11, 2022
Cellvizio I.V.E. system with Confocal Miniprobes510(k)Aug 18, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Aug 18, 2021