FDA WARNING_LETTER - Technological Medical Advancements LLC - April 21, 2025

FDA WARNING_LETTER for Technological Medical Advancements LLC on April 21, 2025. Product: Other. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Technological Medical Advancements LLC on April 21, 2025. Product: Other. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 820.22

21 U.S.C. 360j(g)

FD&C Act 520(g)

21 CFR 801.40(a)(2)

FD&C Act 502(o)

FD&C Act 510(k)

FD&C Act 501(h)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

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Record Information

Company

Technological Medical Advancements LLC

Inspection Date

April 21, 2025

Product Type

Other

Office

Center for Devices and Radiological Health

People

Barbara A. Marsden (Acting Director)

ID: ce068041-9110-459f-8c87-71f6d4e26b57

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