Northeast Scientific, Inc. 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
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)510(k)May 12, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 12, 2025
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter510(k)Feb 3, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 3, 2023
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter510(k)Jul 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022