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 2026-05-11

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

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P250026

Class 3

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PMA 2026-05-08

Implant, dermal, for aesthetic use

Applicant Prollenium Medical Technologies, Inc.

PMA Number P160042

Class 3

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PMA 2026-05-07

VENTILATOR, HIGH FREQUENCY

Applicant Bunnell, Inc.

PMA Number P850064

Class 3

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PMA 2026-05-07

Microspheres radionuclide

Applicant Sirtex Medical, Inc.

PMA Number P990065

Class 3

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PMA 2026-05-06

CATHETER, CORONARY, ATHERECTOMY

Applicant Boston Scientific Corp

PMA Number P900056

Class 3

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PMA 2026-05-06

STENT, ILIAC

Applicant Boston Scientific Scimed, Inc.

PMA Number P940019

Class 3

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PMA 2026-05-06

Stent, central venous

Applicant Boston Scientific Corporation

PMA Number P980033

Class 3

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PMA 2026-05-06

STENT, ILIAC

Applicant Boston Scientific Corporation

PMA Number P090003

Class 3

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PMA 2026-05-06

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P180043

Class 3

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PMA 2026-05-05

alfapump System

Applicant Sequana Medical NV

PMA Number P230044

Class 3

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PMA 2026-05-05

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb

Applicant Neuros Medical, Inc.

PMA Number P230020

Class 3

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PMA 2026-05-03

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P090016

Class 3

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