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 2023-01-24

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

Applicant Ortho-Clinical Diagnostics

PMA Number P100001

Class 2

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PMA 2023-01-24

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P090028

Class 2

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PMA 2023-01-24

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P030026

Class 2

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PMA 2023-01-13

Cytomegalovirus (cmv) dna quantitative assay

Applicant Abbott Molecular

PMA Number P160044

Class 2

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PMA 2023-01-11

Stimulator, electrical, implantable, for incontinence

Applicant Cirtec Medical Corporation

PMA Number P170001

Class 3

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PMA 2022-12-20

STENT, ILIAC

Applicant Cordis US Corporation

PMA Number P890017

Class 3

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PMA 2022-12-14

heart-valve, non-allograft tissue

Applicant ABBOTT MEDICAL

PMA Number P100029

Class 3

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PMA 2022-11-23

Stimulator, invasive bone growth

Applicant Ahp Eos Buyer, Inc.

PMA Number P790005

Class 3

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PMA 2022-11-09

Scaffold, dissection repair

Applicant Philips Image Guided Therapy Corporation (Formerly Intact)

PMA Number P190027

Class 3

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PMA 2022-11-04

Device, hemostasis, vascular

Applicant Vascular Solutions, Inc.

PMA Number P990037

Class 3

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PMA 2022-11-04

Implant, cochlear

Applicant Oticon Medical

PMA Number P200021

Class 3

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PMA 2022-10-11

Implant, hearing, active, middle ear, partially implanted

Applicant Med-El Elektromedizinische Gerate GmbH

PMA Number P990052

Class 3

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