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 2018-02-16

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Microport Orthopedics, Inc.

PMA Number P030027

Class 3

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PMA 2018-02-16

Sharps needle destruction device

Applicant Sharps Terminator, LLC

PMA Number P120018

Class 2

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PMA 2018-01-12

Excimer laser system

Applicant Nidek Co., Ltd.

PMA Number P970053

Class 3

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PMA 2017-12-14

Analyzer, medical image

Applicant Qview Medical, Inc.

PMA Number P150043

Class 2

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PMA 2017-10-27

Lens, multifocal intraocular

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P960028

Class 3

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PMA 2017-09-20

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Lombard Medical Limited

PMA Number P110032

Class 3

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PMA 2017-09-19

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG

Applicant Zeus Scientific, Inc.

PMA Number P150045

Class 3

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PMA 2017-09-19

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Applicant Zeus Scientific, Inc.

PMA Number P150042

Class 3

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PMA 2017-07-27

Tissue adhesive for internal use

Applicant Cohera Medical, Inc.

PMA Number P130023

Class 3

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PMA 2017-07-18

Implant, corneal, refractive

Applicant Corneagen

PMA Number P120023

Class 3

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PMA 2017-06-23

Single-use internal condom

Applicant Clear Future, Inc.

PMA Number P080002

Class 2

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PMA 2017-06-19

SYSTEM, ESOPHAGEAL PACING

Applicant Cardio Command

PMA Number P860008

Class 3

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