Product code MRD ยท 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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2019 | Allergan PLC NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L Terminated |
MRD | K831566 |
| Jul 7, 2015 | Allergan Inc Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410.
The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. Terminated |
MRD | K831566 |
| Jan 13, 2015 | Mentor Texas, LP. MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. Terminated |
MRD | K062421 |
| Sep 4, 2014 | Mentor Texas, LP. EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer
REF 351-3380SZ 380 cc LOT 6830722.
Product Usage:
This product is indicated for single use Terminated |
MRD | K010709 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.