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 2025-02-04

Automated breast ultrasound

Applicant GE Healthcare

PMA Number P110006

Class 3

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PMA 2025-01-17

Stimulator, bone growth, non-invasive

Applicant Enovis

PMA Number P210016

Class 3

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PMA 2025-01-16

Excimer laser system

Applicant Alcon Laboratories, Inc.

PMA Number P030008

Class 3

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PMA 2025-01-16

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P110027

Class 3

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PMA 2025-01-15

AID, SURGICAL, VISCOELASTIC

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P110007

Class 3

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PMA 2025-01-14

Coronary drug-eluting stent

Applicant Boston Scientific Corp

PMA Number P110010

Class 3

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PMA 2025-01-10

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Applicant Smith & Nephew, Inc.

PMA Number P040033

Class 3

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PMA 2025-01-07

Device, thermal ablation, endometrial

Applicant CooperSurgical, Inc.

PMA Number P160047

Class 3

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PMA 2025-01-06

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG

Applicant Diasorin

PMA Number P970054

Class 3

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PMA 2025-01-06

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Applicant Diasorin

PMA Number P970055

Class 3

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PMA 2025-01-02

Acid, hyaluronic, intraarticular

Applicant Sanofi Genzyme Corp.

PMA Number P940015

Class 3

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PMA 2024-12-19

Barrier, absorbable, adhesion

Applicant Baxter Healthcare Corporation

PMA Number P950034

Class 3

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