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 2025-12-23

Acid, hyaluronic, intraarticular

Applicant Mesoblast

PMA Number P170016

Class 3

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PMA 2025-12-22

heart-valve, non-allograft tissue

Applicant Corcym S.r.l.

PMA Number P150011

Class 3

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PMA 2025-12-22

Fluid, intraocular

Applicant Bausch & Lomb

PMA Number P910071

Class 3

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PMA 2025-12-19

Automated external defibrillators (non-wearable)

Applicant Graphic Controls D.B.A. Vermed

PMA Number P200007

Class 3

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PMA 2025-12-18

Device, hemostasis, vascular

Applicant Vasorum, Ltd.

PMA Number P150006

Class 3

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PMA 2025-12-18

DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Applicant Spectranetics (Philips)

PMA Number P960042

Class 3

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PMA 2025-12-18

Sealant, polymerizing

Applicant Baxter Bio Science

PMA Number P030039

Class 3

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PMA 2025-12-17

Device, thermal ablation, endometrial

Applicant Hologic, Inc.

PMA Number P010013

Class 3

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PMA 2025-12-16

Lens, contact (rigid gas permeable), extended wear

Applicant Bausch & Lomb

PMA Number P860022

Class 3

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PMA 2025-12-16

Lens, contact, orthokeratology, overnight

Applicant Bausch & Lomb

PMA Number P010062

Class 3

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PMA 2025-12-16

Organ care system (OCS) heart system

Applicant TransMedics, Inc.

PMA Number P180051

Class 3

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PMA 2025-12-15

Drug coated prostatic dilation catheter for benign prostatic hyperplasia

Applicant Urotronic, Inc.

PMA Number P220029

Class 3

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