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 2025-10-10

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

Applicant DiaSorin, Inc.

PMA Number P180038

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 P180039

Class 2

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PMA 2025-10-10

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant Medtronic, Inc.

PMA Number P200028

Class 3

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PMA 2025-10-07

Hepatitis Viral B DNA Detection

Applicant Hologic, Inc.

PMA Number P170025

Class 2

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PMA 2025-10-06

Ring, endocapsular

Applicant Ophtec BV

PMA Number P030023

Class 3

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PMA 2025-09-29

Iliac covered stent, arterial

Applicant Bard Peripheral Vascular, Inc.

PMA Number P160024

Class 3

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PMA 2025-09-19

Stent, carotid

Applicant Boston Scientific Corp

PMA Number P050019

Class 3

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PMA 2025-09-18

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010050

Class 2

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PMA 2025-09-18

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

Applicant Siemens Healthcare Diagnostics Products, Ltd.

PMA Number P010052

Class 2

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PMA 2025-09-17

Diagnostic low electric field

Applicant Dilon Medical Technologies, Ltd.

PMA Number P110014

Class 3

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PMA 2025-09-17

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Howmedica Osteonics Corp.

PMA Number P000013

Class 3

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PMA 2025-09-08

Implant, dermal, for aesthetic use

Applicant Croma-Pharma GmbH

PMA Number P240008

Class 3

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