Why is "510(k)" trending?

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• Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments - PR Newswire
• FDA Grants 510(k) Clearance to GE HealthCare's True Definition DL Software - Imaging Technology News
• Philips Wins FDA 510(k) Clearance for AI Heart Valve Repair Solution - Yahoo Finance
• Bio Solutions’ Successful Study Advances FDA Drug Screening - The Clinical Trial Vanguard
• FDA grants 510(k) clearance to Urocross Expander System for BPH-related LUTS - Urology Times
• DCwire micro guidewire receives US FDA 510(k) clearance - NeuroNews International
• A fingerprint drug test moved closer to a U.S. launch after codeine study - Stock Titan
• Philips expands access to cardiac MR with FDA 510(k) clearance of AI-Powered SmartHeart - philips.com
• Zeto Announces FDA 510(k) Clearance of Zeto New Wave™, Advancing Efficiency in Outpatient EEG - PR Newswire
• Developer Submits 510(k) Premarket Notification for SC Infusion System in HER2+ BC - CancerNetwork
• Intelligent Bio Solutions Completes Clinical Cut-off Study, Advances FDA 510(k) Clinical Program Targeting Multi-Billion-Dollar U.S. Drug Screening Market - The Manila Times
• Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities - Yahoo Finance
• Roche receives FDA 510(k) clearance for cobas® c703 and cobas® ISE neo, next-generation analytical units enhancing efficiency and capability for laboratories - PR Newswire
• GE HealthCare Wins FDA 510(k) Clearance for Photonova Spectra PCCT - Yahoo Finance
• MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System - PR Newswire
• GE HealthCare (GEHC) Receives FDA 510 (k) Clearance for View - Yahoo Finance
• Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone - PR Newswire
• Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation endomina® EZFuse system - PR Newswire
• DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical's Global Expansion - PR Newswire
• Natus announces FDA 510(k) clearance for electrographic status epilepticus diagnostic indication in BrainWatch point-of-care EEG solution - PR Newswire
• Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System - Orthopedics This Week
• StimLabs® Announces FDA 510(k) Clearance for DermaForm™, a Collagen Scaffold Particulate Wound Care Device - PR Newswire
• Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology - PR Newswire
• Cairn Surgical Announces FDA De Novo 510(k) Submission for Breast Cancer Locator System - Business Wire
• GEHC Wins FDA 510(k) Approval for View, Enhances Radiology Workflows - Yahoo Finance
• Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology - PR Newswire
• Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty - Business Wire
• FDA grants 510(k) clearance to Revi System against urgency urinary incontinence - Contemporary OB/GYN
• BD Receives FDA 510(k) Clearance for EnCor EnCompass™ Breast Biopsy and Tissue Removal System - PR Newswire
• GE HealthCare secures FDA 510(k) clearance for diagnostic viewer - Medical Device Network
• Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions Webinar - ResearchAndMarkets.com - Business Wire
• Spinal Elements' 3D printed Ventana A ALIF devices receives FDA 510(k) clearance - tctmagazine.com
• Quanterix Submits FDA 510(k) for Multi-Analyte Alzheimer's Blood Test - Yahoo Finance
• FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones - Urology Times
• Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding Class II Medical Device Functionality and PET-CT Capabilities - PR Newswire
• Heartflow Plaque Analysis Platform Receives FDA 510(k) Clearance - dicardiology.com
• Elekta Gets FDA 510(k) Clearance for Linear Accelerator - Imaging Technology News
• The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices - MedTech Intelligence
• Hubly Surgical Auto-Stop Drill Receives FDA 510(k) Clearance for Spinal Decompression Surgery: Laminectomy and Laminotomy - orthospinenews.com
• MedCAD's AccuStride™ Fixation Plates Receive 510(k) FDA Clearance to Complete Foot and Ankle System Offering - PR Newswire
• FDA grants 510(k) clearance to enhanced Revi System for urgency urinary incontinence - Urology Times
• Quanterix Submits FDA 510(k) for Multi-Analyte Alzheimer’s Blood Test - Clinical Lab Products
• Swift Medical Receives FDA 510(k) Clearance for Swift Ray™ Spectral Imaging Device - The Topeka Capital-Journal
• Catalyst OrthoScience Receives FDA 510(k) Clearance for Expanded Indications of the Fracture Shoulder System - Business Wire
• FDA clarifies 510(k) clearance transfer rules in new Q&A guidance - hoganlovells.com
• BlueWind Medical Receives FDA 510(k) Clearance for Enhanced Revi® Wearable Supporting Long-Term Treatment of Urgency Urinary Incontinence - Business Wire
• AS Software Announces FDA 510(k) Clearance of Asera™, its Next Generation Ultrasound Reporting Cloud Platform - Business Wire
• Molecular Designs Submits Simplicity™DX Respiratory Panel for FDA 510(k) Clearance - PR Newswire
• LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System - GlobeNewswire
• KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic - Business Wire
• New FDA 510(k) Clearance Expands Bayer’s MEDRAD® MRXperion MR Injection System Support Across Diverse Range of MR Environments - Business Wire
• AMDI Submits 510(k) and CLIA Waiver Dual Submission to FDA - PR Newswire
• Prodeon Medical Receives FDA 510(k) Clearance for the Urocross® Expander System, a Novel Non-Permanent Retrievable Implant for Treating Urinary Symptoms Associated with Benign Prostatic Hyperplasia - GlobeNewswire
• FDA Grants 510(k) Clearance to EXENT System for Multiple Myeloma Diagnosis - OncLive
• AI Enters The 510(k) Submission World: What Device Developers Need To Know - Med Device Online
• Neurophet bags 510(k) for Alzheimer's imaging AI and more briefs - MobiHealthNews
• Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology - PR Newswire
• Venus Concept (VERO) receives 510(k) clearance for Venus NOVA; U.S. availability Dec 2025 - Stock Titan
• UV Smart Announces FDA 510(k) Clearance for D60 TEE Probe Disinfection System - Business Wire
• FluidAI Medical's Origin™ device has received FDA 510(k) clearance, a pivotal milestone redefining the future of data-driven, post-operative care - PR Newswire
• BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System - PR Newswire
• Joint Preservation Innovations Announces FDA 510(k) Clearance for the Articulator™ Arthroscopic Bur — the First and Only FDA-Cleared Articulating Rotary Cutting Instrument - orthospinenews.com
• Aptar Digital Health Announces FDA 510(k) Clearance for HeroTracker® Sense - Aptar
• SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System - Yahoo Finance
• Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening - Yahoo Finance
• Philips Advances MRI Speed and Precision with FDA 510(k) Clearance of SmartSpeed Precise [1] Dual AI Software - philips.com
• Allevion Medical™ Receives 510K Clearance for Vantage™ — A Fully Disposable Kit Featuring a Novel Approach to Spinal Decompression - Business Wire
• ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use - GlobeNewswire
• Welldoc Submits 510(k) to FDA for CGM-Informed Glucose Prediction Feature - Business Wire
• Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio - BioSpace
• BlueOcean Global Announces FDA 510(k) Clearance of the Excelsior™ External Fixation System - GlobeNewswire
• Cresco Spine Receives FDA 510(k) Clearance for the Spring Distraction System (SDSTM) - Orthopedics This Week
• ASUS Handheld Ultrasound LU800 Receives US FDA-510(k) Clearance - ASUS Pressroom
• Stereotaxis Synchrony System Gets European CE Mark; Applies for FDA 510(k) Certification - dicardiology.com
• Intracardiac Imaging System Gets FDA 510(k) Clearance - Imaging Technology News
• Toro Neurovascular Announces FDA 510(k) Clearance for Toro 88 Superbore Catheter - GlobeNewswire
• AccurKardia Secures FDA 510(k) Clearance of and Launches AccurECG 2.0 - Business Wire
• ManaMed® Secures FDA 510(k) Clearance for PlasmaFlow® X -- a Breakthrough, Compact Sequential Compression System with All-Day Battery - PR Newswire
• Naitive® Receives FDA 510(k) Clearance for OsteoSight™, AI-Enabled Opportunistic Bone Health Assessment - PR Newswire
• BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test :: Becton, Dickinson and Company (BDX) - Becton Dickinson
• Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1™, a Breakthrough Wearable Device for Essential Tremor - Business Wire
• InterVene receives US FDA 510(k) clearance for Recana thrombectomy system - Venous News
• News - NMRC Partnership Receives 510(k) Clearance for XSTAT P15 Wound Treatment Device - DVIDS
• QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay - PR Newswire
• LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System - Yahoo Finance
• HeartBeam (BEAT) Secures FDA 510(k) Clearance for 12-Lead ECG Synthesis Software Following Successful Appeal - Yahoo Finance
• Gentherm Announces FDA 510(k) Submission for Innovative Technology Expected to Promote Safer Surgeries and Better Patient Outcomes - Yahoo Finance
• GE HealthCare Receives FDA 510(k) Clearance for Revolution Vibe CT System - dicardiology.com
• Nanox Receives FDA 510(k) Clearance for TAP2D New Image - GlobeNewswire
• Mode Sensors Receives FDA 510(k) for Fluid Monitoring System - Business Wire
• ACR sends FDA a wish list for AI device 510(k) exemption petition - auntminnie.com
• Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Business Wire
• InterVene Receives FDA 510(k) Clearance for Recana®, the First Fully Integrated Thrombectomy System for Venous In-Stent Restenosis and Native Vessel Obstructions - Business Wire
• Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance - PR Newswire
• FDA grants 510(k) clearance to new edition of Focal One robotic HIFU - Urology Times
• Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope - GlobeNewswire
• FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities - BioSpace
• Vesalio receives two US FDA 510(k) clearances for aspiration devices - Vascular News
• BrainSpace gets 510(k) nod for brain fluid management system and more FDA clearances - MobiHealthNews
• mlHealth 360 secures FDA 510(k) for ICH triage tool - auntminnie.com