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 2022-07-12

System, test, tumor marker, for detection of bladder cancer

Applicant Abbott Diagnostics Scarborough, Inc.

PMA Number P940035

Class 3

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PMA 2022-07-11

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Applicant Bd Diagnostics

PMA Number P950009

Class 3

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PMA 2022-06-17

Optoacoustic Imaging System

Applicant Seno Medical Instruments, Inc.

PMA Number P200003

Class 3

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PMA 2022-06-16

Lens, contact (rigid gas permeable), extended wear

Applicant CooperVision, Inc.

PMA Number P870024

Class 3

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PMA 2022-06-16

Automated external defibrillators (non-wearable)

Applicant Conmed Corporation

PMA Number P200004

Class 3

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PMA 2022-06-14

Stimulator, bone growth, non-invasive

Applicant Orthofix, Inc.

PMA Number P030034

Class 3

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PMA 2022-06-14

Stimulator, bone growth, non-invasive

Applicant Orthofix, Inc.

PMA Number P850007

Class 3

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PMA 2022-06-13

Filler, bone void, synthetic peptide

Applicant Biomimetic Therapeutics, LLC

PMA Number P100006

Class 3

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PMA 2022-05-26

Device, thermal ablation, endometrial

Applicant Axora Medical, Inc.

PMA Number P000040

Class 3

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PMA 2022-05-26

STENT, ILIAC

Applicant Bard Peripheral Vascular, Inc.

PMA Number P080007

Class 3

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PMA 2022-05-10

Lens, contact, orthokeratology, overnight

Applicant CooperVision, Inc.

PMA Number P050031

Class 3

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PMA 2022-04-29

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P150019

Class 3

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