Medela, LLC 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
Freestyle Mini Hands-free510(k)Apr 10, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Apr 10, 2026
Motion InBra (YM-8801) wearable breast pump510(k)Feb 13, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Feb 13, 2026
Pump In Style® Pro+510(k)Jan 22, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Jan 22, 2026
Duo Hands-free Breast Pump510(k)Apr 12, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Apr 12, 2024
Solo, Swing Maxi510(k)Aug 11, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Aug 11, 2021