ClearanceBrief
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)
Get daily alerts for FTRSample briefCSV

Top companies in FTR

Company510(k)sRecalls
Allergan PLC012
Inamed Corp01
Mentor Texas, LP.01
DateFirm and productCodeLinked 510(k)
Nov 6, 2019Allergan 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
FTRNone listed
Nov 6, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan PLC
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
Open, Classified
FTRNone listed
Sep 11, 2019Allergan PLC
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
Open, Classified
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan PLC
Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
Open, Classified
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan PLC
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
Open, Classified
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Sep 11, 2019Allergan 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
FTRNone listed
Jul 1, 2016Mentor Texas, LP.
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Terminated
FTRNone listed
Oct 15, 2003Inamed 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
FTRNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.