抓取结果

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. 32417510(k)940PMA10413Companies8083Trials Latest TrendsDuring this period, 32417 medical devices received FDA 510(k) clearance and 940 devices received Premarket Approval (PMA) . Top categories: LLZ (802 devices), GEX (625 devices), GEI (580 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (178), Arthrex, Inc. (171). Latest FDA PMA ApprovalsMost recent Premarket Approval decisions PMA2026-07-09Drug-Eluting Peripheral Transluminal Angioplasty CatheterApplicant LutonixPMA Number P130024Class 3View Details →PMA2026-07-09Drug-coated peripheral transluminal angioplasty catheterApplicant LutonixPMA Number P170003Class 3View Details →PMA2026-07-09Embolization Agent, VascularApplicant Sirtex Medical, Inc.PMA Number P220020Class 3View Details →PMA2026-07-09Scaffold, infrapopliteal, absorbableApplicant ABBOTT MEDICALPMA Number P230036Class 3View Details →PMA2026-07-09Implant, dermal, for aesthetic useApplicant Merz North America, Inc.PMA Number P250016Class 3View Details →PMA2026-07-08Device, thermal ablation, endometrialApplicant Channel Medsystems, Inc.PMA Number P180032Class 3View Details → Latest FDA 510(k) ClearancesMost recent medical device clearances PFO2026-07-10Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® SystemApplicant Cochlear AmericasK-Number K260902View Details →ESW2026-07-10WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemApplicant Boston Scientific CorporationK-Number K261978View Details →KNT2026-07-10Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)Applicant C.R. Bard, Inc.K-Number K253514View Details →FOZ2026-07-10ClearSafe Closed SystemApplicant MedSource Labs, LLCK-Number K261041View Details →LLZ2026-07-10Avara ViewerApplicant Avara SoftwareK-Number K262120View Details →LSR2026-07-10Sofia Lyme FIA; Sofia 2 Campylobacter FIAApplicant Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)K-Number K254295View Details →OWB2026-07-10SmartCT (R3.0 (L10))Applicant Philips Medical Systems B.V.K-Number K253670View Details →EOQ2026-07-10LungFlow Airway CatheterApplicant Free Flow Medical, Inc.K-Number K254037View Details →LPH2026-07-10Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentApplicant Howmedica Osteonics Corp., Dba Stryker OrthopaedicsK-Number K261624View Details →MQP2026-07-10POSEIDON STApplicant Signus Medinzintechnik GmbHK-Number K261031View Details →SCA2026-07-10Flowflex Plus RSV + Flu A/B + COVID Rapid TestApplicant ACON Laboratories, Inc.K-Number K261212View Details →OLW2026-07-10SedLine Sedation MonitorApplicant Masimo CorporationK-Number K260880View Details →View all FDA 510(k) Clearances Latest PubMed ResearchRecent medical device publications from PubMed / NCBIPubMedR WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27.Journal Journal of comparative effectiveness researchYear 2026Read More →PubMedRegulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.Journal Journal of pathology informaticsYear 2026Read More →PubMedUnited States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends.Journal World neurosurgeryYear 2026Read More →PubMedReview of regulatory requirements for benefit - risk assessment for medical devices: uncovering existing methodologies.Journal Expert review of medical devicesYear 2026Read More →PubMedBorrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.Journal Journal of wound careYear 2026Read More →PubMedInnovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.Journal Digital healthYear 2026Read More → FDA Medical Device RecallsLatest recalls and safety alerts from FDAClass IIZ-2623-2026GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460Reason Reduced or no recovery of some strains of Neisseria gonorrhoeae.Firm Remel, IncView on FDA →Class IIZ-2609-2026Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOReason Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leFirm Medline Industries, LPView on FDA →Class IIZ-2646-2026RayCare 2024A SP1. Oncology Information Systems.Reason Beam set delivery note issues in which there is potential data loss if the beam set delivery note isFirm RAYSEARCH LABORATORIES ABView on FDA →Class IIZ-2656-2026CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Reason Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturerFirm Bard Access Systems, Inc.View on FDA →Class IIZ-2607-2026Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOReason Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leFirm Medline Industries, LPView on FDA →Class IIZ-2629-2026CRE Pro Wireguided 12-15mm 240cmReason Potential sterile breach of the pouches in which devices are packaged.Firm Boston Scientific CorporationView 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: 2026-07-27 12:25:47 This site uses cookies for advertising personalization via Google AdSense. By continuing to browse, you agree to our Privacy Policy. Privacy Policy. Decline Accept

网站标题

爱器械企业导航-医疗器械生产企业厂家大全

关键词

医疗器械,生产器械官方网站网址,行业新闻,行业信息,产品信息,厂家查询,医疗器械查询

站点描述

爱器械使用医保分类三级目录收录医疗器械生产企业、厂家的官方网站网址，方便查询查找到想要的产品和生产厂家以及行业新闻和行业信息。