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 2025-07-23

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Applicant Insightec, Ltd.

PMA Number P040003

Class 3

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PMA 2025-07-23

VENTILATOR, HIGH FREQUENCY

Applicant ZOLL Medical Corporation

PMA Number P890057

Class 3

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PMA 2025-07-18

Covered stent vascular connector, hemodialysis access circuit

Applicant Phraxis, Inc.

PMA Number P240004

Class 3

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PMA 2025-07-16

ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)

Applicant Siemens Healthcare Diagnostics

PMA Number P990055

Class 3

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PMA 2025-07-16

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Siemens Healthcare Diagnostics

PMA Number P950021

Class 3

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PMA 2025-07-11

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Medtimo, Inc.

PMA Number P000008

Class 3

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PMA 2025-07-11

Stimulator, carotid sinus nerve

Applicant Cvrx, Inc.

PMA Number P180050

Class 3

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PMA 2025-07-11

Immunohistochemistry Assay, Antibody, MET

Applicant Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

PMA Number P240037

Class 3

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PMA 2025-07-10

Sealant, polymerizing

Applicant Baxter Healthcare Corporation

PMA Number P100030

Class 3

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PMA 2025-07-03

Implant, cochlear

Applicant Cochlear Americas

PMA Number P890027

Class 3

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PMA 2025-07-03

Implant, cochlear

Applicant Cochlear Americas

PMA Number P840024

Class 3

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PMA 2025-06-24

Intracranial coil-assist stent

Applicant Stryker Neurovascular

PMA Number P180031

Class 3

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