FDA.reportPublic FDA data

ESTABLISHMENT LABS S.A.

Matched from indexed company URL: Establishment Labs S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30128832023012883202ESTABLISHMENT LABS S.A.1N2026-01-01Coyol Free Zone & Business Park Building 4th Street, Building B-15 Coyol Alajuela CR 20113

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2345901685335458P230005Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled BreasFTR2024-09-26
2345901435177977K211676Motiva Flora SmoothSilk Tissue ExpanderLCJ2023-10-13
2345901963847181K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMRD2019-02-05
2345901195633226

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCJ12023-10-13
MRD12019-02-05

GUDID#

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