Cook Incorporated FDA Approvals

0 new drug approvals and 5 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
Nest VT Vitrification Device510(k)Mar 8, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Mar 8, 2024
Gunther Tulip Vena Cava Filter Retrieval Set510(k)May 16, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 16, 2023
Bakri Essential Postpartum Balloon510(k)Oct 28, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Oct 28, 2022
Endovascular Dilator and Sets510(k)Apr 6, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 6, 2021
Extra Large Check-Flo Introducer510(k)Feb 16, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 16, 2021