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 2023-06-12

Prosthesis, intervertebral disc

Applicant Globus Medical, Inc.

PMA Number P100003

Class 3

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PMA 2023-05-31

AID, SURGICAL, VISCOELASTIC

Applicant Bausch & Lomb, Inc.

PMA Number P860047

Class 3

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PMA 2023-05-16

Agent, absorbable hemostatic, collagen based

Applicant Pfizer, Inc.

PMA Number N18286

Class 3

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PMA 2023-05-09

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Uroplasty, LLC

PMA Number P040050

Class 3

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PMA 2023-04-18

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P160012

Class 3

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PMA 2023-04-06

Coronary drug-eluting stent

Applicant Advanced Bifurcation Systems, Inc.

PMA Number P210014

Class 3

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PMA 2023-03-31

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator

Applicant Synapse Biomedical, Inc.

PMA Number P200018

Class 3

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PMA 2023-03-08

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

Applicant Foundation Medicine, Inc.

PMA Number P200016

Class 3

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PMA 2023-03-08

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

Applicant Foundation Medicine, Inc.

PMA Number P200006

Class 3

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PMA 2023-02-22

AID, SURGICAL, VISCOELASTIC

Applicant Bausch Health Companies, Inc.

PMA Number P220009

Class 3

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PMA 2023-02-17

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

Applicant Illumina, Inc.

PMA Number P160038

Class 3

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PMA 2023-02-13

Digital breast tomosynthesis

Applicant Fujifilm Medical Systems U.S.A, Inc.

PMA Number P160031

Class 3

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