Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 2022-10-31

Automated external defibrillators (non-wearable)

Applicant Avive Solutions, Inc.

PMA Number P210015

Class 3

View Details →

PMA 2022-10-11

Implant, hearing, active, middle ear, partially implanted

Applicant Med-El Elektromedizinische Gerate GmbH

PMA Number P990052

Class 3

View Details →

PMA 2022-10-07

Stent, urethral, prostatic, semi-permanent

Applicant Srs Medical

PMA Number P060010

Class 3

View Details →

PMA 2022-10-06

Leadless pacemaker

Applicant ABBOTT MEDICAL

PMA Number P150035

Class 3

View Details →

PMA 2022-09-29

Hybrid stent graft, thoracic aortic lesion treatment

Applicant Vascutek, Ltd.

PMA Number P210006

Class 3

View Details →

PMA 2022-07-22

VENTILATOR, HIGH FREQUENCY

Applicant ZOLL Medical Corporation

PMA Number P890057

Class 3

View Details →

PMA 2022-07-20

Cytomegalovirus (cmv) dna quantitative assay

Applicant Hologic, Inc.

PMA Number P210029

Class 2

View Details →

PMA 2022-05-03

Stimulator, bone growth, non-invasive

Applicant Orthofix US, LLC

PMA Number P210035

Class 3

View Details →

PMA 2022-04-14

Coronary drug-eluting stent

Applicant Biosensors International USA, Inc.

PMA Number P190020

Class 3

View Details →

PMA 2022-03-29

Implant, resorbable, for articular osteochondral repair

Applicant Smith and Nephew, Inc.

PMA Number P210034

Class 3

View Details →

PMA 2022-03-17

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

Applicant Datex-Ohmeda, Inc., A General Electric Company

PMA Number P210018

Class 3

View Details →

PMA 2021-12-21

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

PMA Number P200041

Class 3

View Details →

Page 13 of 78

↑