Zien Medical Technologies, Inc. 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
ZIEN IO Intraosseous Access System510(k)Jul 2, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 2, 2024
LANDMARK REBOA Catheter510(k)Sep 19, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 19, 2022