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FDA Medical Device Regulatory Records | MedTracker Skip to content ◈MedTracker Home 510(k) PMA Trials PubMed Recalls NEW News LanguageEnglish简体中文繁體中文日本語한국어FrançaisDeutschEspañolPortuguêsРусский 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. 32917510(k)946PMA10527Companies10598Trials Latest TrendsDuring this period, 32917 medical devices received FDA 510(k) clearance and 946 devices received Premarket Approval (PMA) . Top categories: LLZ (811 devices), GEX (635 devices), GEI (585 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (253), Boston Scientific Corporation (182), Arthrex, Inc. (174). Latest FDA PMA ApprovalsMost recent Premarket Approval decisions PMA2026-09-04Acid, hyaluronic, intraarticularApplicant Seikagaku Corp.PMA Number P080020Class 3View Details →PMA2026-09-04Implant, cochlearApplicant Advanced BionicsPMA Number P960058Class 3View Details →PMA2026-09-04Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncementedApplicant DePuy Orthopaedics, Inc.PMA Number P070026Class 3View Details →PMA2026-09-04Acid, hyaluronic, intraarticularApplicant Seikagaku Corp.PMA Number P980044Class 3View Details →PMA2026-09-04Tissue graft of 6mm and greaterApplicant LeMaitre Vascular, Inc.PMA Number N16837Class 3View Details →PMA2026-09-04Next generation sequencing oncology panel, somatic or germline variant detection systemApplicant Guardant Health, Inc.PMA Number P200010Class 3View Details → Latest FDA 510(k) ClearancesMost recent medical device clearances NUH2026-09-06Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Applicant Shenzhen Osto Medical Technology Co.,LtdK-Number K261131View Details →OBP2026-09-06KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Applicant Fidelity BioPharma Co.K-Number K260396View Details →QPB2026-09-05LipoSurg ARTISTApplicant NOUVAG AGK-Number K254135View Details →MLY2026-09-05FreezeSpray TAApplicant Cryosurgery, Inc.K-Number K261684View Details →MYE2026-09-04Gastric AlimetryApplicant Alimetry , Ltd.K-Number K262292View Details →LLZ2026-09-043D-RD-SApplicant Radiopharmaceutical Imaging & Dosimetry, LLCK-Number K262060View Details →KCT2026-09-04Surgical and Prosthetic TraysApplicant Dentsply Sirona, Inc.K-Number K261935View Details →EZL2026-09-04TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Applicant Sentinel Medical Technologies,K-Number K260756View Details →JAK2026-09-04FCT iStream Phase 2Applicant Fujifilm CorporationK-Number K253836View Details →QJP2026-09-0470 NeuGlide CatheterApplicant Piraeus Medical, Inc.K-Number K262277View Details →QVF2026-09-04Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAApplicant Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)K-Number K254264View Details →PGW2026-09-04ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)Applicant Medtronic Xomed, Inc.K-Number K262235View Details →View all FDA 510(k) Clearances Latest PubMed ResearchRecent medical device publications from PubMed / NCBIPubMedThree Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995-2025).Journal CureusYear 2026Read More →PubMedSafety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.Journal Journal of neurosurgery. PediatricsYear 2026Read More →PubMedPremarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.Journal JAMA health forumYear 2026Read More →PubMedImage-based evaluation of a commercial AI synthetic CT generator for brain and prostate MR-only radiotherapy.Journal Journal of applied clinical medical physicsYear 2026Read More →PubMedSleep Diagnostics and Monitoring Technology in Obstructive Sleep Apnea.Journal Continuum (Minneapolis, Minn.)Year 2026Read More →PubMedCompetitive value of acquiring novel FDA product codes for medical device manufacturers: an original investigation.Journal npj health systemsYear 2025Read More → FDA Medical Device RecallsLatest recalls and safety alerts from FDAClass IIZ-3057-2026Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1Reason The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potentiaFirm Medline Industries, LPView on FDA →Class IIZ-2953-2026One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway DeReason Devices could potentially be occluded or partially occluded.Firm Intersurgical IncView on FDA →Class IIZ-3029-2026Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98203Reason Kits contain a potentially contaminated component which were recalled by the manufacturerFirm Medline Industries, LPView on FDA →Class IIZ-2914-2026GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, seReason 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diametFirm W L Gore & Associates, Inc.View on FDA →Class IIZ-2945-2026Cardinal Health Presource Kits: 1) ENT TRAY , Catalog NumbeReason Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variFirm Cardinal Health 200, LLCView on FDA →Class IIZ-3046-2026Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/ItemReason The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling Firm AVID Medical, Inc.View on FDA → ↑ 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 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: 2026-09-18 06:04:33 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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