Rb Health (Us), LLC FDA Approvals

0 new drug approvals and 8 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
Durex Polyisoprene Condom510(k)Feb 28, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Feb 28, 2025
Belle Sensilube510(k)Jun 20, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jun 20, 2023
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine510(k)Mar 7, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Mar 7, 2023
Durex Patronus CloseFit, Durex Patronus Regular510(k)Nov 7, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2022
Durex Penck III Regular510(k)Oct 12, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
Durex Condom with Benzocaine510(k)May 11, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	May 11, 2022
Durex Patronus Wide510(k)Feb 17, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Feb 17, 2022
Grosz Play Feel510(k)Jul 9, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jul 9, 2021