Product Code: FTR


Products Classified as FTR

5530Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filledSilicone Gel-filled Breast Prosthesis.

Total Product Life Cycle (TPLC) Devices

5530Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filledSilicone Gel-filled Breast Prosthesis.

FDA Consensus Standards

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled [37532]21 CFR §878.3540 🔎

Pre-market Approvals for FTR

P020056NATRELLE Silicon-Filled Breast ImplantsAllergan
P040046NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast ImplantsAllergan
P030053MemoryGel Silicone Gel-Filled Breast ImplantsMENTOR CORP.
P060028Mentor MemoryShape Breast ImplantsMENTOR WORLDWIDE LLC
P070004Sientra OPUS Silicone Gel Breast ImplantsSIENTRA, INC

Global Unique Device Identification Database

00812790025916Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025909Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025893Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025886Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025879Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025862Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025855Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025848Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025831Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025824Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025817Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025756Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025749Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
00812790025732Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Maude Adverse Events

MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
UNKNOWN GEL IMPLANTS TEXTUREDMENTOR TEXAS2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
STYLE 115 SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
STYLE 15 SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
STYLE 20 SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
MENTOR MEMORYGEL BREAST IMPLANTMENTOR TEXAS2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
STYLE 15 SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31
STYLE 40 SILICONE GEL FILLED BREAST IMPLANTALLERGAN (COSTA RICA)2020-03-31

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