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MedTracker - Global Medical Device Approval Tracker Skip to content ◈MedTracker Home 510(k) PMA Trials PubMed 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. 32345510(k) 933PMA 10431Companies 5922Trials Latest TrendsDuring this period, 32345 medical devices received FDA 510(k) clearance and 933 devices received Premarket Approval (PMA) . Top categories: LLZ (794 devices), GEX (622 devices), GEI (570 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (249), Boston Scientific Corporation (177), Arthrex, Inc. (169). Latest FDA PMA Approvals Most recent Premarket Approval decisions PMA 2026-05-29 Ventricular (assist) bypass Applicant ABBOTT MEDICAL PMA Number P060040 Class 3 View Details → PMA 2026-05-29 Lenses, soft contact, extended wear Applicant Alcon Laboratories, Inc. PMA Number P010019 Class 3 View Details → PMA 2026-05-29 Coronary drug-eluting stent Applicant Medtronic Vascular PMA Number P160043 Class 3 View Details → PMA 2026-05-29 Implanted electrical device intended for treatment of fecal incontinence Applicant Boston Scientific Corporation PMA Number P190006 Class 3 View Details → PMA 2026-05-29 Stimulator, electrical, implantable, for incontinence Applicant Boston Scientific Corporation PMA Number P180046 Class 3 View Details → PMA 2026-05-29 Leadless pacemaker Applicant ABBOTT MEDICAL PMA Number P150035 Class 3 View Details → Latest FDA 510(k) Approvals Most recent medical device clearances HWC 2026-05-30 CoLink® & CoLag® Non-Sterile Screws Applicant In2Bones USA, LLC K-Number K261154 View Details → QNP 2026-05-30 GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) Applicant Cosmo Artificial Intelligence - Ai, Ltd. K-Number K261369 View Details → MAX 2026-05-29 Exceed® Biplanar Expandable Interbody System Applicant Spine Wave, Inc. K-Number K261159 View Details → FCM 2026-05-29 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit Applicant C.R. Bard, Inc. K-Number K254076 View Details → DQK 2026-05-29 ZEUS Platform (FG0501US) Applicant iRhythm Technologies, Inc. K-Number K252859 View Details → OLO 2026-05-29 Navigated LLIF Impactable Tracker Applicant Tyber Medical, LLC K-Number K261060 View Details → CCJ 2026-05-29 CoSense ETCO Monitor Applicant Capnia, Inc. K-Number K253119 View Details → QIH 2026-05-29 OrthoGrid Hip AI® 4.0 Applicant OrthoGrid Systems, Inc. K-Number K260077 View Details → GEI 2026-05-29 ENTire IRE System Applicant Entire Medical , Ltd. K-Number K261202 View Details → QTZ 2026-05-29 HistoSonics® Planning Tool Applicant HistoSonics, Inc. K-Number K252947 View Details → LPL 2026-05-29 Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus Applicant INTEROJO, Inc. K-Number K260507 View Details → DQA 2026-05-29 Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) Applicant Philips Medizin Systeme Böblingen GmbH K-Number K252821 View Details → IRP 2026-05-29 Cryo Sport 2.0 (AVA 501) Applicant Avanutri Equipamentos DE Saúde K-Number K252396 View Details → BZH 2026-05-29 Peak Flow Meter (PF-10(BR-PEF231)) Applicant Shenzhen Bi-Rich Medical Devices Co., Ltd. K-Number K252802 View Details → HGX 2026-05-29 eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) Applicant Anker Innovations Limited K-Number K254300 View Details → FBK 2026-05-29 Injection Needle Applicant Mirco-Tech (Nanjing) Co., Ltd. K-Number K260262 View Details → CAW 2026-05-29 Oxygen Concentrator (OX-5A, OX-5C) Applicant Oxytek Medical Technology Co., Ltd. K-Number K252965 View Details → JAA 2026-05-29 Nexus DRF Digital X-ray Imaging System Applicant Varex Imaging Corporation K-Number K253103 View Details → MHX 2026-05-29 M12 Telemetry System Applicant Global Instrumentation, LLC K-Number K252840 View Details → GEX 2026-05-29 LUNE PureHygiene Applicant Enamel Pure K-Number K260138 View Details → HRS 2026-05-29 Xpert PFP Applicant Newclip Technics K-Number K261038 View Details → GEX 2026-05-29 LASEmaR 1500 Applicant Eufoton S.R.L. K-Number K260489 View Details → MAX 2026-05-28 BMD Titanium Spinal Fusion System Applicant Global Biomedica s.r.o. K-Number K253894 View Details → FDF 2026-05-28 Disposable Endoscopic Distal Attachments Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd. K-Number K260423 View Details → MAI 2026-05-28 Arthrex Bioabsorbable PushLock Suture Anchors Applicant Arthrex, Inc. K-Number K253931 View Details → QIH 2026-05-28 ANDI 2.2 Applicant Imeka Solutions, Inc. K-Number K261405 View Details → MUE 2026-05-28 Bellalun 2D (VDMS-1000S) Applicant Vieworks Co., Ltd. K-Number K254092 View Details → MDB 2026-05-28 BD BACTEC FXI Culture System Applicant BD Diagnostic Systems K-Number K260213 View Details → IZI 2026-05-28 780 nm SPY Portable Handheld Imaging (SPY-PHI) System Applicant Stryker Endoscopy K-Number K261037 View Details → FRG 2026-05-28 Dukal Crepe Paper Sterilization Wrap Applicant Dukal, LLC K-Number K252823 View Details → No matching devices found. Latest PubMed Research Recent medical device publications from PubMed / NCBI PubMed Interpreting the two-hour partial REBOA safety window: Physiologic context, monitoring limitations, and device-specific considerations. Journal The journal of trauma and acute care surgery Year 2026 Read More → PubMed Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal Journal of multidisciplinary healthcare Year 2026 Read More → PubMed A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal Journal of imaging informatics in medicine Year 2026 Read More → PubMed Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal Journal of robotic surgery Year 2026 Read More → PubMed Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities. Journal Frontiers in drug safety and regulation Year 2026 Read More → PubMed Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Journal Studies in health technology and informatics 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 © 2026 MedTracker. Data sourced from public government APIs. Build: 2026-06-15 06:08:31

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