Panels › General, Plastic Surgery › Product code FTR · Class 3
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Regulation 878.3540
0510(k)s in 12 months (0 all time)
0recalls in 12 months (14 all time)
0recalls that name a 510(k)
Top companies in FTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Allergan PLC | 0 | 12 |
| Inamed Corp | 0 | 1 |
| Mentor Texas, LP. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2019 | Allergan PLC Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 76 Terminated |
FTR | None listed |
| Nov 6, 2019 | Allergan PLC Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45
Style 10/UDI:
NATRELLE Style 10-180 Gel Round Mod 10888628001206,
NATRELL Terminated |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH.
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch
Product Usage : Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers:
Style 110:110-090,
110-120,
110-150,
110-180,
110-210,
110-240,
110-270,
11 Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers:
Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410, Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers:
Syle LL: LL-410135,LL-410180,LL-410210,LL Open, Classified |
FTR | None listed |
| Jul 1, 2016 | Mentor Texas, LP. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Terminated |
FTR | None listed |
| Oct 15, 2003 | Inamed Corp McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier
Catalog Numbers:
25-40401
25-40461
25-40501
25-40561 Terminated |
FTR | None listed |
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