This page includes the latest FDA filings for Establishment Labs S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| COSTA RICA | NASDAQ | ESTA | DUNS 853166098 |
| Registration Number | 3012883202 |
| FEI Number | 3012883202 |
| Name | Renee Gaeta |
| Owner & Operator | Establishment Labs S.A. |
| Contact Address | Coyol Free Zone & Business Park Building 4th Street, Building B-15 Alajuela CR-A Alajuela 10138-1000 CR |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 712 Fifth Avenue, 14th Floor New York, NY 10019 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-475 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-425 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-380 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-360 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-340 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-320 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-300 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-285 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-265 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-245 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-230 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-215 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-205 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-190 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-180 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-155 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-475 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-430 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-400 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-360 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-310 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-290 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-275 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-260 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-245 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-230 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-220 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-205 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-185 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-170 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-160 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-150 | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-625+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-550+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-500+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-450+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-425+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-400+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-375+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-355+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-335+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-315+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-295+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-275+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-255+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-525+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-475+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-425+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-380+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-360+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-340+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-320+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-300+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-285+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-265+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-245+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-230+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-215+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-205+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-400+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-360+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-310+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-290+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-275+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-260+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-245+Q | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-625+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-550+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-500+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-450+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-425+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-400+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-375+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-355+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-335+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-315+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-295+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-275+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSF-255+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-525+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-475+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-425+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-380+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-360+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-340+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-320+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-300+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-285+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-265+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-245+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-230+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-215+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSD-205+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-400+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-360+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-310+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-290+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-275+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-260+ | 2024-10-14 |
| Establishment Labs S.A. | Motiva® SmoothSilk® Round Breast Implant RSM-245+ | 2024-10-14 |
Renee Gaeta [Establishment Labs S.A.] | Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix? | 2019-10-29 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019072357500 | Puerto Limon,Costa Rica -> Port Everglades, Florida | PRINTED LABELS | 5 PKG |
| 2019072357519 | Puerto Limon,Costa Rica -> Port Everglades, Florida | PRINTED LABELS | 5 PKG |
| 2019071774060 | Puerto Limon,Costa Rica -> Port Everglades, Florida | PRINTED LABELS | 5 PKG |
| 2019071774081 | Puerto Limon,Costa Rica -> Port Everglades, Florida | PRINTED LABELS | 5 PKG |
| 2018022869671 | Puerto Limon,Costa Rica -> Miami, Florida | 18 PKGS CONTAINING 3D SCANERS NET WEIGHT 1890 KGS HS-CODE 847141 | 18 PKG |