FDA WARNING_LETTER - ExThera Medical Corporation - June 04, 2025

FDA WARNING_LETTER for ExThera Medical Corporation on June 04, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ExThera Medical Corporation on June 04, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

FD&C Act 502(o)

21 U.S.C. 352(o)

FD&C Act 501(f)(1)(B)

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

FD&C Act 515(a)

21 U.S.C. 360e(a)

FD&C Act 520(g)

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

FD&C Act 510(k)

21 U.S.C. 360(k)

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Record Information

Company

ExThera Medical Corporation

Inspection Date

June 4, 2025

Product Type

devices

Office

Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)

People

ID: 94e1b48e-b077-4795-ad2c-a50e50be67a6

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