Bk Medical Aps 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
Ultrasound System 1300510(k)Oct 23, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2023
Ultrasound System 2300510(k)Apr 11, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 11, 2023
Ultrasound System 2300510(k)Dec 7, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 7, 2022