Mentor Worldwide, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsApril 24, 2025
K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel January 13, 2025
K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderJanuary 12, 2025
K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerSeptember 6, 2024
K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderAugust 2, 2024
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceSeptember 25, 2018
K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMay 23, 2016
K152496CPX 4 Breast Tissue ExpanderFebruary 19, 2016
K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMay 20, 2015
K150777Artoura Breast Tissue ExpanderApril 24, 2015
K142998CPX Control Breast Tissue ExpanderDecember 19, 2014
K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERJuly 17, 2013