Bionet Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
Cardio Q50, Cardio Q70510(k)Dec 15, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 15, 2023
Cardio P1510(k)Nov 9, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023
Cardio10510(k)Nov 15, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 15, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)510(k)Oct 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 11, 2022