Home › Device types › FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FDA product code FWM · Class 3 · General, Plastic Surgery
297
Registered devices
117,615
Adverse events
9
Recalls
0
510(k) clearances
Devices with this code
NATRELLE Saline-Filled Breast Implants — Allergan, Inc.MENTOR Smooth Round Moderate Profile — MENTOR TEXAS L.P.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.MENTOR Smooth Round SPECTRUM — MENTOR TEXAS L.P.MENTOR Smooth Round SPECTRUM — MENTOR TEXAS L.P.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.MENTOR Smooth Round SPECTRUM — MENTOR TEXAS L.P.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.MENTOR Smooth Round Moderate Plus Profile — MENTOR TEXAS L.P.MENTOR Smooth Round High Profile — MENTOR TEXAS L.P.MENTOR Smooth Round Moderate Plus Profile — MENTOR TEXAS L.P.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.MENTOR Smooth Round Moderate Plus Profile — MENTOR TEXAS L.P.MENTOR SILTEX Round Moderate Profile — MENTOR TEXAS L.P.MENTOR Smooth Round Moderate Profile — MENTOR TEXAS L.P.MENTOR SILTEX CONTOUR PROFILE SPECTRUM — MENTOR TEXAS L.P.NATRELLE Saline-Filled Breast Implants — Allergan, Inc.Puregraft Serene Breast Implant — Bimini Technologies LLCIDEAL IMPLANT — IDEAL IMPLANT INCORPORATEDMENTOR Smooth Round Moderate Profile — MENTOR TEXAS L.P.MENTOR Smooth Round Moderate Plus Profile — MENTOR TEXAS L.P.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-30 | Mentor Texas, LP. | Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the aff |
| 2019-11-06 | Allergan PLC | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separa |
| 2019-07-24 | Allergan PLC | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplast |
| 2019-03-18 | Ideal Implant Incorporated | The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. |
| 2017-03-27 | Mentor Texas, LP. | Missing Dome Pack accessory. |
| 2005-12-14 | Inamed Corp | Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these tw |
| 2005-12-14 | Inamed Corp | Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these tw |
| 2005-05-05 | Inamed Corp | Wrong size implant was mislabeled. |
| 2003-08-01 | Inamed Corp | Labeling mixup. |
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