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 2026-02-05

Test, urea adult and pediatric (breath),

Applicant Arj Medical, Inc.

PMA Number P170022

Class 3

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PMA 2026-02-03

Kit, rna detection, human papillomavirus

Applicant Gen-Probe Incorporated

PMA Number P100042

Class 3

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PMA 2026-02-03

Kit, rna detection, human papillomavirus

Applicant Gen-Probe Incorporated

PMA Number P120007

Class 3

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PMA 2026-02-02

Over-the-counter automated external defibrillator

Applicant Philips Medical Systems, Inc.

PMA Number P160029

Class 3

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PMA 2026-01-29

Prosthesis, intervertebral disc

Applicant Highridge Medical, LLC

PMA Number P120024

Class 3

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PMA 2026-01-27

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant Boston Scientific Corp

PMA Number P950020

Class 3

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PMA 2026-01-23

Implant, cochlear

Applicant Med-El Corp.

PMA Number P000025

Class 3

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PMA 2026-01-23

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

Applicant Qiagen

PMA Number P010033

Class 3

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PMA 2026-01-22

Stent graft, bypass, superficial femoral artery

Applicant Endologix, LLC

PMA Number P220021

Class 3

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PMA 2026-01-16

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX

Applicant Torax Medical

PMA Number P100049

Class 3

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PMA 2026-01-15

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant MicroPort CRM USA, Inc.

PMA Number P130010

Class 3

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PMA 2026-01-14

Tissue adhesive internal use

Applicant Advanced Medical Solutions Limited

PMA Number P220024

Class 3

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