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MedTracker - Global Medical Device Approval Tracker Skip to content ◈MedTracker Home 510(k) PMA Trials PubMed Recalls NEW News 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 Medical DeviceApproval Tracker Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search. 32652510(k) 939PMA 10523Companies 7057Trials Latest TrendsDuring this period, 32652 medical devices received FDA 510(k) clearance and 939 devices received Premarket Approval (PMA) . Top categories: LLZ (798 devices), GEX (625 devices), GEI (577 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (178), Arthrex, Inc. (171). Latest FDA PMA Approvals Most recent Premarket Approval decisions PMA 2026-06-26 Implantable cardioverter defibrillator (non-CRT) Applicant ABBOTT MEDICAL PMA Number P950022 Class 3 View Details → PMA 2026-06-26 Implant, dermal, for aesthetic use Applicant Merz North America, Inc. PMA Number P050052 Class 3 View Details → PMA 2026-06-26 Implant, dermal, for aesthetic use Applicant Merz North America, Inc. PMA Number P050037 Class 3 View Details → PMA 2026-06-26 AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE Applicant Merz North America, Inc. PMA Number P040047 Class 3 View Details → PMA 2026-06-26 Intracranial aneurysm flow diverter Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular PMA Number P100018 Class 3 View Details → PMA 2026-06-26 Intracranial aneurysm flow diverter Applicant Stryker Neurovascular PMA Number P170024 Class 3 View Details → Latest FDA 510(k) Approvals Most recent medical device clearances NHA 2026-06-27 MIST IC Applicant Imagine Milling Technologies, LLC K-Number K261122 View Details → GWF 2026-06-27 BraiN20® (BraiN20) Applicant Time IS Brain, S.L. K-Number K253301 View Details → OLZ 2026-06-27 SOMNUM (SOMNUM) Applicant Honeynaps Co., Ltd. K-Number K253390 View Details → NHA 2026-06-26 BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2) Applicant BioHorizons Implant Systems, Inc. K-Number K260061 View Details → OLO 2026-06-26 VERTICALE® Navigation Instruments Applicant Silony Medical GmbH K-Number K253921 View Details → SAN 2026-06-26 PhAST instrument and PhAST Blood Culture Gram-negative Panel Applicant Phast Corp. K-Number K253316 View Details → CGL 2026-06-26 i-STAT Crea cartridge with the i-STAT 1 System Applicant Abbott Point of Care, Inc. K-Number K261039 View Details → DXF 2026-06-26 LightningWire Transseptal Puncture System (TPS) Applicant ElectroWire Medical K-Number K261745 View Details → DQO 2026-06-26 Arterial Pressure Monitoring Set/Tray Applicant Spectrum Vascular K-Number K261455 View Details → MBI 2026-06-26 Arthrex FiberButton Applicant Arthrex, Inc. K-Number K260018 View Details → HGX 2026-06-26 Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) Applicant Shenzhen Changkun Technology Co., Ltd. K-Number K250070 View Details → GXY 2026-06-26 Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array Applicant Cadwell Industries, Inc. K-Number K261442 View Details → View all FDA 510(k) Clearances No matching devices found. Latest PubMed Research Recent medical device publications from PubMed / NCBI PubMed Digital Mental Health: A Narrative Review of FDA-Authorized Products for Psychiatric Treatment and Diagnostic Support. Journal Brain sciences Year 2026 Read More → PubMed Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy. Journal Expert review of medical devices Year 2026 Read More → PubMed Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases. Journal Therapeutic innovation & regulatory science Year 2026 Read More → PubMed Regulating digital surgery to balance safety and innovation: a SAGES white paper. Journal Surgical endoscopy Year 2026 Read More → PubMed Two decades of growth and trends in the FDA authorization of digital medical devices. Journal NPJ digital medicine Year 2026 Read More → PubMed Artificial intelligence in urology: A review of United States Food and Drug Administration-cleared devices. Journal BJU international Year 2026 Read More → ↑ Disclaimer This site aggregates publicly available data from official government sources including FDA, ClinicalTrials.gov, PubMed, and SEC EDGAR. The information provided is for general reference only and does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice. Always consult the original source or a qualified healthcare professional for official guidance. MedTracker Global Medical Device Approval Tracker Data sources: FDA Open API · ClinicalTrials.gov · PubMed Pages FAQAboutPrivacyTermsContact Data Sources FDA 510(k) ClinicalTrials.gov PubMed / NCBI SEC EDGAR Stay Updated Get daily FDA medical device clearances and PMA approvals delivered to your inbox. Subscribe No spam. Unsubscribe anytime. See Privacy Policy. © 2026 MedTracker. Data sourced from public government APIs. Build: 2026-07-07 06:04:22 This site uses cookies for advertising personalization via Google AdSense. By continuing to browse, you agree to our Privacy Policy. Decline Accept

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