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FDA WARNING LETTEROctober 20, 2026

Tides Medical LLC — FDA Warning Letter

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

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Warning-letter details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Company
Tides Medical LLC
Letter date
October 20, 2026
Issuing office
Center for Biologics Evaluation and Research (CBER)
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