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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.

32209510(k)
931PMA
10404Companies
50Trials

Latest Trends

During this period, 32209 medical devices received FDA 510(k) clearance and 931 devices received Premarket Approval (PMA) . Top categories: LLZ (792 devices), GEX (618 devices), GEI (566 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (248), Boston Scientific Corporation (176), Arthrex, Inc. (168).

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

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Latest PubMed Research

Recent medical device publications from PubMed / NCBI

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