Product code MRD · Class U
Mammary Sizer
0510(k)s in 12 months (13 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in MRD
| Company | 510(k)s | Recalls |
|---|---|---|
| Mentor Worldwide, LLC | 4 | 0 |
| Allergan | 1 | 2 |
| Mentor Corp. | 2 | 0 |
| Mentor Texas, LP. | 0 | 2 |
| Specialty Surgical Products, Inc. | 2 | 0 |
| Cox-Uphuff Intl. | 1 | 0 |
| General Surgical Innovations | 1 | 0 |
| Motiva USA, LLC | 1 | 0 |
| Sientra, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2025 | K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer Mentor Worldwide, LLC | MRD |
| Sep 6, 2024 | K241552 | MENTOR MemoryGel Enhance Single Use Gel Sizer Mentor Worldwide, LLC | MRD |
| Jun 2, 2021 | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants Allergan | MRD |
| Nov 16, 2020 | K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer Sientra, Inc. | MRD |
| Feb 5, 2019 | K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix Motiva USA, LLC | MRD |
| May 20, 2015 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE Mentor Worldwide, LLC | MRD |
| Jul 17, 2013 | K131853 | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER Mentor Worldwide, LLC | MRD |
| Oct 10, 2006 | K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER Mentor Corporation | MRD |
| Apr 23, 2001 | K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS Mentor Corp. | MRD |
| Feb 12, 1999 | K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER Specialty Surgical Products, Inc. | MRD |
| Sep 8, 1998 | K982258 | MAMMARY SIZER Specialty Surgical Products, Inc. | MRD |
| Sep 23, 1996 | K961356 | MAMMARY SIZER General Surgical Innovations | MRD |
| Aug 12, 1983 | K831566 | CUI MAMMARY PROTHESIS SIZER Cox-Uphuff Intl. | MRD |
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