Establishment Labs S.A.
US Last updated 23 May 2026
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- Devices
- 177
- Registries
- GUDIDEUDAMEDFDA
- FDA recalls
- 0
Catalogue
Motiva® Channel Separator MCS-20US Ref MCS-20US
Motiva® SmoothSilk® Round Breast Implant RSM-245+ Ref RSM-245+
Flora™ Tissue Expander SMOOTHSILK® H-11-345 Ref H-11-345
Motiva® SmoothSilk® Round Breast Implant RSD-205+Q Ref RSD-205+Q
Motiva® SmoothSilk® Round Breast Implant RSD-340+ Ref RSD-340+
Motiva® SmoothSilk® Round Breast Implant RSM-260+ Ref RSM-260+
Motiva® SmoothSilk® Round Breast Implant RSM-275+ Ref RSM-275+
Flora™ Tissue Expander SMOOTHSILK® L-12-345 Ref L-12-345
Motiva® SmoothSilk® Round Breast Implant RSF-255+ Ref RSF-255+
Motiva® SmoothSilk® Round Breast Implant RSF-295+Q Ref RSF-295+Q
Motiva® SmoothSilk® Round Breast Implant RSF-375+Q Ref RSF-375+Q
Motiva® SmoothSilk® Round Breast Implant RSF-625+ Ref RSF-625+
Flora™ Tissue Expander SMOOTHSILK® H-13-545 Ref H-13-545
Motiva® SmoothSilk® Round Breast Implant RSF-500+ Ref RSF-500+
Motiva® SmoothSilk® Round Breast Implant RSF-400+Q Ref RSF-400+Q
Motiva® SmoothSilk® Round Breast Implant RSM-245+Q Ref RSM-245+Q
Motiva® SmoothSilk® Round Breast Implant RSM-290+Q Ref RSM-290+Q
Flora™ Tissue Expander SMOOTHSILK® L-11-260 Ref L-11-260
Motiva® SmoothSilk® Round Breast Implant RSF-255+Q Ref RSF-255+Q
Flora™ Tissue Expander SMOOTHSILK® M-14-605 Ref M-14-605
Motiva® SmoothSilk® Round Breast Implant RSD-340+Q Ref RSD-340+Q
Motiva® SmoothSilk® Round Breast Implant RSD-475+ Ref RSD-475+
Motiva® SmoothSilk® Round Breast Implant RSF-550+Q Ref RSF-550+Q
Motiva® SmoothSilk® Round Breast Implant RSM-400+Q Ref RSM-400+Q
Motiva® SmoothSilk® Round Breast Implant RSD-285+ Ref RSD-285+
Flora™ Tissue Expander SMOOTHSILK® M-13-490 Ref M-13-490
Showing 1-50 of 177
FDA establishments
- Establishment Labs S.A. Coyol Alajuela · CR FEI 3012883202
What Establishment Labs S.A. makes
Establishment Labs S.A. manufactures silicone gel-filled breast implants with smooth surfaces, designed for reconstructive and cosmetic procedures. Their portfolio also includes skin-port tissue expanders, which are used in staged breast reconstruction to gradually expand tissue before implant placement.
The company’s devices are classified as Class III under FDA regulations, indicating they require premarket approval due to their substantial risk. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device reporting requirements.
Frequently asked questions
What types of medical devices does Establishment Labs S.A. manufacture?
Establishment Labs S.A. specializes in silicone gel-filled breast implants with smooth surfaces, primarily used for reconstructive and cosmetic procedures. They also produce skin-port tissue expanders, which are essential in staged breast reconstruction to gradually expand tissue before implant placement.
Where is Establishment Labs S.A. based?
The company is based in the United States, as indicated by its regulatory and manufacturing context.
Which regulatory registries list Establishment Labs S.A.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and compliance with U.S. medical device reporting requirements. This registry helps track and monitor devices for regulatory purposes.
How are Establishment Labs S.A.’s devices classified under U.S. regulations?
The devices manufactured by Establishment Labs S.A. fall under Class III classification by the FDA. This classification is assigned to high-risk medical devices that require premarket approval due to their potential risks and benefits, ensuring rigorous evaluation before market authorization.
Information
- Country
- US
- DUNS number
- 853166098