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 Medical Device
Approval Tracker

Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search.

186510(k)
150PMA
244Companies
50Trials

Latest Trends

During this period, 186 medical devices received FDA 510(k) clearance and 150 devices received Premarket Approval (PMA) . Top categories: LWS (11 devices), IYN (7 devices), QIH (7 devices). Most active applicants: Medtronic, Inc. (16), Medtronic Cardiac Rhythm Disease Management (8), Biotronik, Inc. (7).

Latest FDA PMA Approvals

Most recent Premarket Approval decisions

Latest FDA 510(k) Approvals

Most recent medical device clearances

HQC 2026-05-15

Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+

Applicant Bausch and Lomb

K-Number K261264

View Details →

Latest PubMed Research

Recent medical device publications from PubMed / NCBI

↑