Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology

Vesalio, a leader in innovative thrombectomy solutions, today announced two new FDA 510(k) clearances for its aspiration ...

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION ...

Eminent Spine’s 3D Printed Titanium Posterior SI System Receives FDA 510(k) Clearance

Eminent Spine, a leader in spinal implant innovation, proudly announces that its revolutionary 3D Printed Titanium Posterior ...

Pace Surgical Receives FDA 510(k) Clearance for Ultra Compression Screw System for Foot and Ankle Reconstruction

Article updated to correct “Jim Krieg” to “James Kreig” MALVERN, PENNSYLVANIA / ACCESS Newswire / November 12, 2025 / Pace ...
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Emblation Secures FDA 510(k) Clearance for Swift™ & SwiftPro™ Systems in Treatment of Common and Plantar Warts

Microwave therapy is proven to be the smarter, safer, less painful choice for wart treatment across the US and UK.Emblation, the company redefining medical microwave technology, has received FDA 510(k ...

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA(TM) Plan -- Marking the First Step in Its Hyper-Precise Aortic Care Platform

ViTAA Medical Solutions Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for AiORTA (TM) Plan, the company's fully automated, hyper-precise aortic ...

Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries

Integra LifeSciences will spotlight the CUSA Clarity Ultrasonic Surgical Aspirator System at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, ...

Meduloc Receives FDA 510(k) Clearance for Novel Orthopedic Fracture Fixation System

Meduloc, an orthopedic surgical device company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary intramedullary fracture fixation ...

Hubly Surgical Auto-Stop Drill Receives FDA 510(k) Clearance for Spinal Decompression Surgery: Laminectomy and Laminotomy

Hubly Surgical today announced FDA 510(k) clearance expanding Hubly Auto-Stop Drill indications to include spinal decompression procedures. To date, many thousands of neurosurgical patient lives have ...
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T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it ...

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform

FDA clearance marks a pivotal milestone in ViTAA’s broader AiORTA™ suite, designed to support physicians across the full ...