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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. 32287510(k) 933PMA 10417Companies 5475Trials Latest TrendsDuring this period, 32287 medical devices received FDA 510(k) clearance and 933 devices received Premarket Approval (PMA) . Top categories: LLZ (793 devices), GEX (620 devices), GEI (568 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (249), Boston Scientific Corporation (177), Arthrex, Inc. (168). Latest FDA PMA Approvals Most recent Premarket Approval decisions PMA 2026-05-22 Device, hemostasis, vascular Applicant Abbott Vascular, Inc. PMA Number P960043 Class 3 View Details → PMA 2026-05-22 Coronary drug-eluting stent Applicant Abbott Vascular PMA Number P110019 Class 3 View Details → PMA 2026-05-22 Prosthesis, spinous process spacer/plate Applicant Companion Spine France PMA Number P110008 Class 3 View Details → PMA 2026-05-22 Scaffold, infrapopliteal, absorbable Applicant ABBOTT MEDICAL PMA Number P230036 Class 3 View Details → PMA 2026-05-21 Drug-Eluting Peripheral Transluminal Angioplasty Catheter Applicant Medtronic, Inc. PMA Number P140010 Class 3 View Details → PMA 2026-05-21 Implant, hearing, active, middle ear, totally implanted Applicant Envoy Medical Corporation PMA Number P090018 Class 3 View Details → Latest FDA 510(k) Approvals Most recent medical device clearances GCJ 2026-05-24 MediBot Needle Driver Uno Applicant Parallel Robotics, LLC K-Number K260183 View Details → PZX 2026-05-22 ATLAAS (Atraumatic Left Atrial Appendage System) (AD) Applicant Genesee Biomedical, Inc. K-Number K252917 View Details → QIH 2026-05-22 Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning Applicant Canon Medical Informatics, Inc. K-Number K260324 View Details → IYN 2026-05-22 SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 Applicant CHISON Medical Technologies Co., Ltd. K-Number K253949 View Details → MMK 2026-05-22 Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong Applicant Taizhou Huangyan Guanhong Plastic Steel Products Factory K-Number K253773 View Details → MUJ 2026-05-22 eXaSkin Plus Applicant Anatomical Geometry S.L. K-Number K252784 View Details → OBP 2026-05-22 MagVenture Accelerated TMS (aTMS) Therapy System Applicant Tonica Elektronik A/S K-Number K260189 View Details → OWB 2026-05-22 C-beam Applicant Pulmera, Inc. K-Number K252735 View Details → KOI 2026-05-22 TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) Applicant Senzime AB K-Number K261098 View Details → NAY 2026-05-22 da Vinci Firefly Imaging System Applicant Intuitive Surgical K-Number K260695 View Details → NFT 2026-05-22 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel Applicant Vivachek Biotech (Hangzhou) Co., Ltd. K-Number K261280 View Details → NYV 2026-05-22 Atmo Gas Capsule System Applicant Atmo Biosciences, Ltd. K-Number K253569 View Details → MUD 2026-05-22 Spectrum-2 Applicant Neko Health AB K-Number K254129 View Details → LNH 2026-05-22 uMR Astra Applicant Shanghai United Imaging Healthcare Co., Ltd. K-Number K260113 View Details → QJP 2026-05-22 Zenith Distal Access Long Sheath Applicant Suzhou Zenith Vascular SciTech Limited K-Number K253359 View Details → OLO 2026-05-22 Ion-C Navigation Instruments Applicant SurGenTec, LLC K-Number K260329 View Details → N/A 2026-05-22 PCWP Analysis Software Applicant Cardiosense, Inc. K-Number DEN250057 View Details → DXC 2026-05-22 Arc Adjustable Radial Cuff Compression Device Applicant Tz Medical, Inc. K-Number K252772 View Details → KGO 2026-05-22 Sterile Latex Powder Free Surgical Gloves Applicant Protect Gloves Company Limited K-Number K253060 View Details → OIY 2026-05-22 DePuy ATTUNE™ Knee System Applicant DePuy Orthopaedics, Inc. K-Number K252887 View Details → DQD 2026-05-22 AiSteth® Applicant Ai Health Highway India Pvt., Ltd. K-Number K252915 View Details → OBP 2026-05-22 Apollo TMS Therapy System;Apollo light TMS Therapy System Applicant Mag & More GmbH K-Number K260560 View Details → DQX 2026-05-22 InQwire Amplatz Guide Wire Applicant Merit Medical Ireland, Ltd. K-Number K254137 View Details → OHV 2026-05-21 Ulthera® System Applicant Ulthera, Inc. K-Number K260618 View Details → PKL 2026-05-21 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) Applicant Olympus Medical Systems Corp. K-Number K260580 View Details → LPL 2026-05-21 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses Applicant Pegavision Corporation K-Number K253352 View Details → KPS 2026-05-21 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family Applicant Siemens Medical Solutions USA, Inc. K-Number K261315 View Details → FMF 2026-05-21 Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) Applicant Hlb Lifescience Co., Ltd. K-Number K253112 View Details → NUC 2026-05-21 pjur NATURE Touch, 100 ml Applicant Pjur Group Luxembourg S.A. K-Number K260068 View Details → QME 2026-05-21 PanopticAI Vital Signs (1.6.1-22) Applicant PanopticAI Technologies Limited K-Number K260066 View Details → No matching devices found. Latest PubMed Research Recent medical device publications from PubMed / NCBI 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 FeAsibility items Checklist for assessing implementation characTeristics of patient reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): development and evaluation. Journal Clinical medicine (London, England) Year 2026 Read More → PubMed [Legal responsibility in AI-assisted radiological reporting]. Journal Radiologie (Heidelberg, Germany) 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 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal Journal of neurosurgery. Case lessons 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: 2026-06-06 06:07:08

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