FDA.reportPublic FDA data

Saline-filled breast implant, unstructured, smooth-surface

Definition
An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume and shell thickness.
GUDID devices
62
Last updated
2025-03-25 13:49:35

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10081317028670MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502225D2025-03-17
10081317028687MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502250D2025-03-17
10081317028694MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502275D2025-03-17
10081317028700MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502300D2025-03-17
10081317028717MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502325D2025-03-17
10081317028724MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502350D2025-03-17
10081317028731MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502375D2025-03-17
10081317028748MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502400D2025-03-17
10081317028755MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502425D2025-03-17
10081317028762MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502450D2025-03-17
10081317028779MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502175D2025-03-17
10081317028786MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502200D2025-03-17
10081317028793MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502475D2025-03-17
10081317028809MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502500D2025-03-17
10081317028816MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502550D2025-03-17
10081317028823MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502600D2025-03-17
10081317028830MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502650D2025-03-17
10081317028847MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502700D2025-03-17
10081317028854MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502750D2025-03-17
10081317028861MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.3502800D2025-03-17
10081317028939MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503170D2025-03-17
10081317028946MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501655D2025-03-17
10081317028953MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503190D2025-03-17
10081317028960MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503210D2025-03-17
10081317028977MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501660D2025-03-17
10081317028984MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501670D2025-03-17
10081317028991MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501680D2025-03-17
10081317029004MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501685D2025-03-17
10081317029011MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501690D2025-03-17
10081317029028MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501695D2025-03-17
10081317029035MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501697D2025-03-17
10081317029042MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503230D2025-03-17
10081317029059MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503250D2025-03-17
10081317029066MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503270D2025-03-17
10081317029073MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503290D2025-03-17
10081317029080MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503310D2025-03-17
10081317029097MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503330D2025-03-17
10081317029103MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503380D2025-03-17
10081317029110MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503420D2025-03-17
10081317029127MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503460D2025-03-17
10081317029134MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503500D2025-03-17
10081317029141MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503560D2025-03-17
10081317029158MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.3503630D2025-03-17
10081317030468MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501410D2025-03-17
10081317030475MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501420D2025-03-17
10081317030482MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501430D2025-03-17
10081317030499MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501440D2025-03-17
10081317030505MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501450D2025-03-17
10081317030512MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501460D2025-03-17
10081317030529MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501470D2025-03-17
10081317030536MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501480D2025-03-17
10081317030543MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501485D2025-03-17
10081317030550MENTOR Smooth Round SPECTRUMMENTOR TEXAS L.P.3501490D2025-03-17
10081317030567MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501610D2025-03-17
10081317030574MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501615D2025-03-17
10081317030581MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501620D2025-03-17
10081317030598MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501625D2025-03-17
10081317030604MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501630D2025-03-17
10081317030611MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501635D2025-03-17
10081317030628MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501640D2025-03-17
10081317030635MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501645D2025-03-17
10081317030642MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.3501650D2025-03-17