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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. 32732510(k)945PMA10489Companies9586Trials Latest TrendsDuring this period, 32732 medical devices received FDA 510(k) clearance and 945 devices received Premarket Approval (PMA) . Top categories: LLZ (809 devices), GEX (630 devices), GEI (582 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (181), Arthrex, Inc. (173). Latest FDA PMA ApprovalsMost recent Premarket Approval decisions PMA2026-08-14Stimulator, spinal-cord, totally implanted for pain reliefApplicant Medtronic NeuromodulationPMA Number P840001Class 3View Details →PMA2026-08-14Implanted electrical device intended for treatment of fecal incontinenceApplicant Medtronic NeuromodulationPMA Number P080025Class 3View Details →PMA2026-08-14Stimulator, electrical, implantable, for incontinenceApplicant Medtronic NeuromodulationPMA Number P970004Class 3View Details →PMA2026-08-14Stimulator, electrical, implanted, for parkinsonian tremorApplicant Medtronic, Inc.PMA Number P960009Class 3View Details →PMA2026-08-14DEVICE, ANGIOPLASTY, LASER, CORONARYApplicant Spectranetics Corp.PMA Number P910001Class 3View Details →PMA2026-08-14Coronary drug-eluting stentApplicant Medtronic VascularPMA Number P160043Class 3View Details → Latest FDA 510(k) ClearancesMost recent medical device clearances OLX2026-08-16CN-Suite™Applicant FIND Surgical Sciences Inc. D/B/A FIND NeuroK-Number K260563View Details →MWJ2026-08-14medilogFDApplicant Schiller AGK-Number K253562View Details →OBP2026-08-14QuickVision Ultimate rTMSApplicant Brain Ultimate, Inc.K-Number K261228View Details →KNT2026-08-1452Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Applicant Boehringer Laboratories, LLCK-Number K261890View Details →FMF2026-08-14Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Applicant Jiangsu Enjosim Medical Technology Co., Ltd.K-Number K253747View Details →DQY2026-08-14NHanceITApplicant IMDS Operation B.V.K-Number K260559View Details →QKB2026-08-14AutoContour (RADAC V6)Applicant Radformation, Inc.K-Number K262452View Details →CAW2026-08-14Portable Oxygen Concentrator (PO1 5B, PO1 6B)Applicant BMC Medical Co., Ltd.K-Number K260171View Details →MWI2026-08-14Vital Signs Monitor (CLEO2)Applicant Infinium Medical, Inc.K-Number K260438View Details →FRO2026-08-14Redermax® Antibacterial Wound MatrixApplicant Beijing Kreate Medical Co., Ltd.K-Number K261646View Details →LOX2026-08-14NC Euphora Rapid Exchange Balloon Dilatation CatheterApplicant Medtronic IrelandK-Number K261428View Details →QDQ2026-08-14Transpara (2.1.0)Applicant Screenpoint Medical B.V.K-Number K260898View 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 IIIZ-2881-2026Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Reason out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant CaliFirm Siemens Healthcare Diagnostics, Inc.View 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-2814-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve BReason Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing ElevFirm Windstone Medical Packaging, Inc.View on FDA →Class IIZ-2885-2026Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left andReason Due to an incomplete process of the component screw by a subcontractor which prevents the properly aFirm United Orthopedic Corp.View on FDA →Class IIZ-2818-2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop ReReason Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing ElevFirm Windstone Medical Packaging, 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: 2026-08-27 06:04:09 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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