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 2018-12-27

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Siemens Medical Solutions Diagnostics Limited

PMA Number P060005

Class 3

View Details →

PMA 2018-12-27

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P010007

Class 3

View Details →

PMA 2018-12-26

Agent, absorbable hemostatic, collagen based

Applicant Davol Inc., Sub. C. R. Bard, Inc.

PMA Number N17600

Class 3

View Details →

PMA 2018-12-21

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

Applicant TransMedics, Inc.

PMA Number P160013

Class 3

View Details →

PMA 2018-12-21

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P170018

Class 3

View Details →

PMA 2018-12-20

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160033

Class 3

View Details →

PMA 2018-12-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P000014

Class 2

View Details →

PMA 2018-12-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P030026

Class 2

View Details →

PMA 2018-12-14

Stent, superficial femoral artery, drug-eluting

Applicant Boston Scientific Corp

PMA Number P180011

Class 3

View Details →

PMA 2018-12-13

Stent, carotid

Applicant W. L. Gore & Associates, Inc.

PMA Number P180010

Class 3

View Details →

PMA 2018-12-07

Continuous glucose monitor, implanted, adjunctive use

Applicant Senseonics, Incorporated

PMA Number P160048

Class 3

View Details →

PMA 2018-12-06

Automated external defibrillators (non-wearable)

Applicant Defibtech, LLC

PMA Number P160032

Class 3

View Details →

Page 25 of 78

↑