Biomerics Nle 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
BNLE Hydrophilic Jacketed Peripheral Guidewire510(k)May 14, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 14, 2024
BNLE Access Guidewire510(k)Apr 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 28, 2023