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https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sol-millennium-medical-inc-677524-12222025 Sol-Millennium Medical Inc. - 677524 - 12/22/2025 | FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device solmillenniummedicalincfda