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My DashboardInspection TrackerWarning LettersSkytron, LLC

All Warning Letters

Skytron, LLC

Warning LetterOpen

Skytron, LLC, 5085 Corporate Exchange Blvd SE Grand Rapids , MI 49512 United States, (b)(6)@Skytron.comIssued May 19, 2026Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateMay 19, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Skytron, LLC
Location: Skytron, LLC, 5085 Corporate Exchange Blvd SE Grand Rapids , MI 49512 United States, (b)(6)@Skytron.com
FEI Number: N/A
Country: United States
Issue Date: May 19, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

Skytron, LLC FDA Warning Letter, May 19, 2026