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 2025-06-05

Prosthesis, intervertebral disc

Applicant Nuvasive, Inc.

PMA Number P200022

Class 3

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PMA 2025-05-22

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

Applicant Roche Diagnostics, Inc.

PMA Number P160019

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics Corp.

PMA Number P110022

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics Corp.

PMA Number P110031

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics Operations, Inc.

PMA Number P130015

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics Corp.

PMA Number P010054

Class 2

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PMA 2025-05-22

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Applicant Siemens Healthcare Diagnostics

PMA Number P000021

Class 2

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PMA 2025-05-22

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Siemens Healthcare Diagnostics

PMA Number P020027

Class 3

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PMA 2025-05-22

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

Applicant Roche Diagnostics Corp.

PMA Number P100032

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics Corp.

PMA Number P100031

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics

PMA Number P190034

Class 2

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PMA 2025-05-22

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

Applicant Roche Diagnostics

PMA Number P190005

Class 2

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