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. | PORT LOCATOR MFPL-001 | 2023-12-18 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-16-995 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-15-825 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-14-680 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-13-545 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-12-440 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® H-11-345 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® M-15-750 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® M-14-605 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® M-13-490 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® M-12-375 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® M-11-300 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® L-14-570 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® L-13-440 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® L-12-345 | 2023-12-08 |
| Establishment Labs S.A. | Flora™ Tissue Expander SMOOTHSILK® L-11-260 | 2023-12-08 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-360 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-320 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-285 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-245 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-215 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-190 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-525 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-475 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-290 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-260 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-230 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-205 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-170 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-150 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-1050 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-925 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-825 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-725 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-650 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-590 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-550 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-510 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-475 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-440 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-410 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-380 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-350 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-325 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-300 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-280 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-260 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-240 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-210 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZC-180 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-775 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-700 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-625 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-550 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-500 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-450 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-425 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-400 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-375 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-355 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-335 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-315 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-295 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-275 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-255 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-235 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-220 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-205 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-175 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZF-145 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-625 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-575 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-525 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-475 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-425 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-380 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-340 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-300 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-265 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-230 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-205 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-180 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-155 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZD-135 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-430 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-400 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-360 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-310 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-275 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-245 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-220 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-185 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-160 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-140 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-125 | 2021-11-02 |
| Establishment Labs S.A. | Motiva Implant Matrix SZM-105 | 2021-11-02 |
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 |