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FDA Medical Device Regulatory Records | MedTracker Skip to content ◈MedTracker Home 510(k) Classification PMA Trials PubMed Recalls NEW News AI Assistant 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 Device Regulatory RecordsDaily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search. 169749510(k)951PMA33556Companies12249Trials AI AssistantA free AI assistant that answers only from MedTracker's own FDA, ClinicalTrials.gov and PubMed records. It will tell you when it cannot find something rather than guessing.Ask → Latest TrendsDuring this period, 169749 medical devices received FDA 510(k) clearance and 951 devices received Premarket Approval (PMA) . Top categories: GEX (2781 devices), GEI (2223 devices), LLZ (2151 devices). Most active applicants: Abbott Laboratories (883), Siemens Medical Solutions USA, Inc. (733), Bd Becton Dickinson Vacutainer Systems Preanalytic (632). Latest FDA PMA ApprovalsMost recent Premarket Approval decisions PMA2026-10-09Implanted electrical device intended for treatment of fecal incontinenceApplicant Medtronic NeuromodulationPMA Number P080025View Details →PMA2026-10-09Implant, cochlearApplicant Med-El Corp.PMA Number P000025View Details →PMA2026-10-09implantable pacemaker Pulse-generatorApplicant Biotronik, Inc.PMA Number P950037View Details →PMA2026-10-09Implantable cardioverter defibrillator (non-CRT)Applicant Biotronik, Inc.PMA Number P980023View Details →PMA2026-10-09Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)Applicant Biotronik, Inc.PMA Number P070008View Details →PMA2026-10-09DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBERApplicant Biotronik, Inc.PMA Number P050023View Details → Latest FDA 510(k) ClearancesMost recent medical device clearances CAC2026-10-11Helo™ ReturnApplicant Endovascular Engineering, Inc.K-Number K253717View Details →HRX2026-10-09TruVision Single-Use 1.9mm Arthroscopy SystemApplicant Nexus CMF, LLCK-Number K260156View Details →OHT2026-10-09IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.K-Number K262352View Details →DRF2026-10-09Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)Applicant CathRx, Ltd.K-Number K262068View Details →MQK2026-10-09Fertilis microICSI DeviceApplicant Fertilis Pty, Ltd.K-Number K262090View Details →OAP2026-10-09Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.K-Number K262834View Details →NBW2026-10-09VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.Applicant Vivachek Biotech (Hangzhou) Co., Ltd.K-Number K260687View Details →OLZ2026-10-09Sleep Analysis ModuleApplicant Neurotronics, LLCK-Number K261521View Details →NPM2026-10-09Wishbone HAEApplicant Wishbone SAK-Number K260096View Details →OLO2026-10-09CarboClear® Cervical Navigated InstrumentsApplicant CarboFix Orhtopedics , Ltd.K-Number K263154View Details →DZJ2026-10-09CMF Titanium SplintsApplicant Materialise NVK-Number K260913View Details →LJS2026-10-09Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerApplicant Medical Components, Inc.K-Number K260080View Details →View all FDA 510(k) Clearances Latest PubMed ResearchRecent medical device publications from PubMed / NCBIPubMedCatheter-Directed Interventional Devices for Pulmonary Embolism: A Maude Database Analysis of Adverse Events.Journal Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsYear 2026Read More →PubMedArtificial Intelligence in Health Insurance: An Interagency Framework for Federal and State Oversight.Journal The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & EthicsYear 2026Read More →PubMedFaster but Not Truer, Part 2: The Regulatory Record, the Economics, and the TRACE-HEOR Reporting Standard.Journal Journal of health economics and outcomes researchYear 2026Read More →PubMedProceedings from the Consortium for Technology & Innovation in Pediatrics (CTIP) 2025 annual pediatric device innovation symposium.Journal BMC proceedingsYear 2026Read More →PubMedPost-market safety signals of energy-based surgical devices: a cross-specialty disproportionality analysis of the FDA MAUDE database with robotic-platform validation and regulatory triangulation, 2015-2025.Journal Journal of robotic surgeryYear 2026Read More →PubMedSurgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.Journal Annals of surgeryYear 2026Read More → FDA Medical Device RecallsLatest recalls and safety alerts from FDAClass IIZ-3183-2026REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLReason Reusable access port system may crack or seperate during use.Firm Stryker Sustainability SolutionsView on FDA →Class IIZ-0004-2027Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LIReason Due to incorrect expiration date on product manufactured between September 2016 to March 2023. ProdFirm ASP Global, LLC.View on FDA →Class IIZ-3191-2026Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000Reason Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically traFirm Datex-Ohmeda, Inc.View on FDA →Class IIZ-3192-2026Et Control, Software option for anesthesia gas machine to achieve and maintain tReason Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically traFirm Datex-Ohmeda, Inc.View on FDA →Class IZ-3151-2026Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;Reason Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampulesFirm AVID Medical, Inc.View on FDA →Class IZ-3228-2026Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1070Reason Potential fire hazard involving the hand control pendant and associated wiring used with affected beFirm Medline Industries, LPView on FDA → Advertisement ↑ 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. MedTracker Global Medical Device Approval Tracker Data sources: FDA Open API · ClinicalTrials.gov · PubMed Pages FAQMethodologyData SourcesEditorial PolicyCorrectionsPrivacyTermsContact Data Sources Device Classification FDA 510(k) ClinicalTrials.gov PubMed / NCBI SEC EDGAR Stay Updated Get daily FDA medical device clearances and PMA approvals delivered to your inbox. Email address Subscribe No spam. Unsubscribe anytime. See Privacy Policy. Privacy Policy. © 2026 MedTracker. Data sourced from public government APIs. Build: 2026-10-23 07:18:26 This site uses cookies for advertising personalization via Google AdSense. By continuing to browse, you agree to our Privacy Policy. Privacy Policy. Decline Accept

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