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...
FDA 510(k)
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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...
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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...
FDA Clears BrainSpace Intellidrop to Automate ICU Neuro Care
SEATTLE, Jan. 2, 2026 — U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to BrainSpace for Intellidrop,...
OvertureTi Knee System Reaches $1M Sales Milestone
Irvine, California | December 30, 2025 — Overture Orthopaedics, a U.S.-based medical device company specializing in joint preservation technologies,...
Hubly Auto-Stop Drill Secures FDA 510(k) for Spinal Decompression
Dateline: November 17, 2025 — Lisle, IllinoisHubly Surgical Inc. announced that the Auto-Stop Drill, its cordless surgical tool equipped...
FDA Clears Bridge to Life Organ Preservation Solutions
DULUTH, Ga., Oct. 7, 2025 — Bridge to Life Ltd. has received FDA 510(k) clearance for its multi-sourced Belzer...
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