FDA Clears IO Expandable Wedge for Osteotomy Precision
ATLANTA, Feb. 23, 2026 — MiRus announced U.S. FDA 510(k) clearance and commercial launch of the IO™ Expandable Wedge...
FDA 510(k)
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GYDER Hip Navigation Debuts in U.S. Surgeries
PALO ALTO, USA & MULGRAVE, Australia, Feb. 20, 2026 — Gyder Surgical announced the first commercial surgical cases in...
FDA Clears PhenoMATRIX for Digital Microbiology Labs
PARMA, ITALY — February 17, 2026 Copan Diagnostics announced that its AI-enabled microbiology imaging system PhenoMATRIX has received U.S....
FDA Clears Argos Infinity for Advanced Cardiac Monitoring
WHITE PLAINS, NEW YORK, UNITED STATES — February 16, 2026 Retia Medical has received U.S. FDA 510(k) clearance for...
FDA Clears Collagen Scaffold Device for Wound Care
ROSWELL, Ga., Feb. 12, 2026 — StimLabs announced that the U.S. Food and Drug Administration has granted 510(k) clearance...
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FDA Clears Neurophet AQUA AD Plus in Alzheimer’s AI
Seoul, South Korea — February 6, 2026 Neurophet has announced that the U.S. Food and Drug Administration (FDA) has...
FDA Clears KORU FreedomEDGE for RYSTIGGO Infusion
MAHWAH, N.J., January 29, 2026 — KORU Medical Systems has received U.S. FDA 510(k) clearance expanding the labeled use...
FDA Clears ABANZA QuadLock System for Advanced ACL Fixation
UNITED STATES | January 27, 2026 — ABANZA, a medical technology company focused on advancing soft-tissue fixation solutions, announced...
Spine Innovation Wins FDA 510(k) for LOGIC™ Implant System
CORONADO, CALIFORNIA | January 26, 2026 — Spine Innovation, LLC announced it has received FDA 510(k) clearance to market...
BlueOcean Wins FDA 510(k) Clearance for Excelsior Fixation System
DENVER, COLORADO | January 26, 2026 — BlueOcean Global has received FDA 510(k) clearance for its Excelsior™ External Fixation...
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