Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA Approvals

Premarket Approval devices tracked by MedTracker

PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Corp.

PMA Number P110041

Class 2

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics

PMA Number P090024

Class 2

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P100039

Class 2

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PMA 2025-10-17

Hepatitis Viral B DNA Detection

Applicant Abbott Molecular, Inc.

PMA Number P200013

Class 2

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P200017

Class 2

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P210019

Class 2

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Beckman Coulter, Inc.

PMA Number P230015

Class 2

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PMA 2025-10-10

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Bolton Medical, Inc.

PMA Number P110038

Class 3

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PMA 2025-10-10

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant DiaSorin, Inc.

PMA Number P180048

Class 2

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PMA 2025-10-10

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant DiaSorin, Inc.

PMA Number P180049

Class 2

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PMA 2025-10-10

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant DiaSorin, Inc.

PMA Number P180045

Class 2

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PMA 2025-10-10

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant DiaSorin, Inc.

PMA Number P190017

Class 2

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