Mentor Worldwide, LLC
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories4
Latest FDA decision2026-07-21
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P060028 | Prosthesis, breast, noninflatable, internal, silicone gel-filled | FTR | 2026-07-21 | View |
| PMA | P990075 | Prosthesis, breast, inflatable, internal, saline | FWM | 2026-05-12 | View |
| 510(k) | K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | LCJ | 2025-04-24 | View |
| 510(k) | K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | MRD | 2025-01-13 | View |
| 510(k) | K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | LCJ | 2025-01-12 | View |
| 510(k) | K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | MRD | 2024-09-06 | View |
| 510(k) | K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | LCJ | 2024-08-02 | View |
| 510(k) | K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | LCJ | 2018-09-25 | View |
| 510(k) | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | LCJ | 2016-05-23 | View |
| 510(k) | K152496 | CPX 4 Breast Tissue Expander | LCJ | 2016-02-19 | View |
No matching devices.