Abk Biomedical, 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
Easi-Vue® embolic microspheres System510(k)Feb 13, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 13, 2024
Easi-Vue embolic microspheres System510(k)Sep 7, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 7, 2022