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 2026-09-03

Light adjustable lens (LAL) and light delivery device (LDD)

Applicant Rxsight, Inc.

PMA Number P160055

Class 3

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PMA 2026-09-03

Lens, multifocal intraocular

Applicant Bausch & Lomb, Inc.

PMA Number P240005

Class 3

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PMA 2026-09-03

Embolization Agent, Vascular

Applicant Instylla, Inc.

PMA Number P250003

Class 3

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PMA 2026-09-02

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P080011

Class 3

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PMA 2026-09-02

Lenses, soft contact, extended wear

Applicant Vistakon, Division of Johnson & Johnson Vision Car

PMA Number P040045

Class 3

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PMA 2026-09-02

Acid, hyaluronic, intraarticular

Applicant Ferring Pharmaceuticals, Inc.

PMA Number P010029

Class 3

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PMA 2026-09-02

Ventricular (assist) bypass

Applicant Abbott

PMA Number P170038

Class 3

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PMA 2026-09-02

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Abbott Molecular, Inc.

PMA Number P230003

Class 3

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PMA 2026-09-02

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Tempus AI, Inc.

PMA Number P210011

Class 3

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PMA 2026-09-01

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing

Applicant Biomet Manufacturing Corp

PMA Number P010014

Class 3

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PMA 2026-09-01

Sensor, glucose, invasive

Applicant Abbott Diabetes Care, Inc.

PMA Number P150021

Class 3

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PMA 2026-09-01

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Applicant Abbott Diabetes Care, Inc.

PMA Number P160030

Class 3

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