Diazyme Laboratories Secures FDA Clearance for Lp(a) Assay
POWAY, Calif., June 17, 2026 Diazyme Laboratories, Inc. has received U.S. FDA 510(k) clearance for its Lipoprotein(a) [Lp(a)] Molarity...
FDA 510(k)
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Onkos Surgical Receives FDA Nod for NanoCept-Enhanced Implants
PARSIPPANY, N.J., June 8, 2026 Onkos Surgical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k)...
Waters Secures FDA Clearance for BD BACTEC FXI System
MILFORD, Massachusetts, USA – June 3, 2026 Waters Corporation has announced U.S. Food and Drug Administration (FDA) 510(k) clearance...
Glooko Wins FDA Clearance for EndoTool IV Cloud
PALO ALTO, Calif., May 14, 2026 Glooko, Inc. announced that the U.S. Food and Drug Administration has granted 510(k)...
RIVANNA Gains FDA Clearance for Accuro XV AI System
CHARLOTTESVILLE, Va., May 7, 2026 RIVANNA announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance...
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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...
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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