FDA Clears BD EnCor EnCompass Breast Biopsy System
FRANKLIN LAKES, New Jersey | January 19, 2026 — Becton, Dickinson and Company (BD) announced that the U.S. Food...
FDA 510(k) clearance
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FDA Clears StimLabs’ Theracor, First Umbilical Cord Sheet
ROSWELL, Ga., December 29, 2025 — StimLabs has announced that the U.S. Food and Drug Administration (FDA) has granted...
FDA Clears VaporShield™ as First Direct-Injection CSTD
VANCOUVER, British Columbia — December 16, 2025 — Zephyrus Innovations™, a privately owned medical device company focused on safety-engineered...
Tosoh Bioscience Gains FDA 510(k) Clearance for Rapid GR01 HbA1c Analyzer
Grove City, Ohio – October 30, 2025 — Tosoh Bioscience, Inc., a global leader in clinical diagnostics and laboratory...
FDA Approves VCFix® System for Spinal Fractures and Stability
September 17, 2025 — The Hague, The Netherlands Amber Implants has received FDA 510(k) clearance for its VCFix® Spinal...
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