A comprehensive view of FDA 510(k) Clearance. This page highlights a small sample of our full coverage.
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Abbott announces US availability of minimally-invasive Amplatzer steerable delivery sheath to treat atrial fibrillation patients at risk for ischemic stroke; device is used with Abbott’s Amplatzer Amulet left atrial appendage occluder

Cutera announces FDA clearance of AviClear, the first and only energy-based device approved for treatment of mild, moderate and severe acne; treatment offers long-lasting results by reducing sebum production by the skin

Ra Medical Systems files 510(k) application with FDA for DABRA catheter with braided overjacket, six-month shelf life, for treating infrainguinal lower extremity vascular disease; device made at 32,000 square-foot plant in Carlsbad, California

Tandem Diabetes Care announces FDA clearnace of the t:slim X2 Insulin Pump using the t:connect mobile app; combination enables diabetes patients to program the insulin dosing solution

Olympus announces FDA clearance of the CELERIS single-use sinus debrider system, planning market launch in the near future; device is used in general ear-nose-throat, sinus, rhinology procedures

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