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FDA clearance

Dec 5, 2022

Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh

Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line® Hernia Mesh for the sublay technique in open hernia surgery.

Nov 3, 2020

Durham medtech startup 410 Medical receives FDA clearance for fluid administration device

DURHAM – Durham startup 410 Medical has received U.S. Food and Drug Administration (FDA) 510(k) Clearance for its LifeFlow PLUS Blood and Fluid Infuser (LifeFlow PLUS). This device was modeled after the…

Aug 11, 2020

Durham medtech startup Deep Blue receives FDA clearance for hernia mesh product

DURHAM – Medtech startup Deep Blue Medical Advances can now begin selling a novel hernia mesh product with enhanced anchoring strength following receipt of FDA device (501 K) clearance, which the company announced it…