Company · US
Mentor Worldwide, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2025 | K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs Mentor Worldwide, LLC | LCJ |
| Jan 13, 2025 | K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer Mentor Worldwide, LLC | MRD |
| Jan 12, 2025 | K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue Expander Mentor Worldwide, LLC | LCJ |
| Sep 6, 2024 | K241552 | MENTOR MemoryGel Enhance Single Use Gel Sizer Mentor Worldwide, LLC | MRD |
| Aug 2, 2024 | K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue Expander Mentor Worldwide, LLC | LCJ |
| Sep 25, 2018 | K182335 | CPX 4 Breast Tissue Expander with Smooth Surface Mentor Worldwide, LLC | LCJ |
| May 23, 2016 | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface Mentor Worldwide, LLC | LCJ |
| Feb 19, 2016 | K152496 | CPX 4 Breast Tissue Expander Mentor Worldwide, LLC | LCJ |
| May 20, 2015 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE Mentor Worldwide, LLC | MRD |
| Apr 24, 2015 | K150777 | Artoura Breast Tissue Expander Mentor Worldwide, LLC | LCJ |
| Dec 19, 2014 | K142998 | CPX Control Breast Tissue Expander Mentor Worldwide, LLC | LCJ |
| Jul 17, 2013 | K131853 | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER Mentor Worldwide, LLC | MRD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||