Establishment Labs S.A.
FDA adverse event reports naming Establishment Labs S.A. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ESTABLISHMENT LABS S.A..
- Total reports
- 2,247
- Deaths
- 0
- Injuries
- 2,108
- Malfunctions
- 139
Reports per year
222
223
824
1,38325
85226
Source: FDA adverse event reports by year received, 2022–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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