Mentor Worldwide, 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
MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs510(k)Apr 24, 2025	—	510(k)Substantially Equivalent (Traditional)	Apr 24, 2025
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer510(k)Jan 13, 2025	—	510(k)Substantially Equivalent (Traditional)	Jan 13, 2025
Mentor CPX 4 PLUS Enhance Breast Tissue Expander510(k)Jan 12, 2025	—	510(k)Substantially Equivalent (Special)	Jan 12, 2025
MENTOR MemoryGel Enhance Single Use Gel Sizer510(k)Sep 6, 2024	—	510(k)Substantially Equivalent (Traditional)	Sep 6, 2024
MENTOR CPX4 PLUS Enhance Breast Tissue Expander510(k)Aug 2, 2024	—	510(k)Substantially Equivalent (Special)	Aug 2, 2024