Panels › General, Plastic Surgery › Product code FWM · Class 3
Prosthesis, Breast, Inflatable, Internal, Saline
Regulation 878.3530
0510(k)s in 12 months (0 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in FWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Inamed Corp | 0 | 4 |
| Allergan PLC | 0 | 2 |
| Mentor Texas, LP. | 0 | 2 |
| Ideal Implant Incorporated | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2021 | Mentor Texas, LP. MENTOR Saline-Filled Breast Implants are constructed from room temperature
vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired siz Open, Classified |
FWM | None listed |
| Nov 6, 2019 | Allergan PLC Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP,
Style LP/UDI:
NATRELLE Style 68LP-125 Saline Round Low 10888628000513,
NATRELLE Style 6 Terminated |
FWM | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers:
Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC;
Style 168:168-1 Open, Classified |
FWM | None listed |
| Mar 18, 2019 | Ideal Implant Incorporated IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc. Terminated |
FWM | None listed |
| May 11, 2017 | Mentor Texas, LP. Mentor Smooth Round SPECTRUM Post-
Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 Terminated |
FWM | None listed |
| Dec 31, 2005 | Inamed Corp McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360 Terminated |
FWM | None listed |
| Dec 31, 2005 | Inamed Corp McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380 Terminated |
FWM | None listed |
| May 25, 2005 | Inamed Corp Style 363 Saline-Filled BIOCELL textured Breast Implants Terminated |
FWM | None listed |
| Sep 11, 2003 | Inamed Corp McGhan Round Breast Implant, Saline-Filled BIOCELL textured.
McGhan Shaped Breast Implant Saline Filled BIOCELL textured. Terminated |
FWM | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.