MAQUET Critical Care AB announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its MAQUET FLOW-i anesthesia system, including the C20, C30 and C40 models. FLOW-i is a high performance system designed to meet ventilatory challenges within anesthesia, as well as to provide inhalation anesthesia in a broad range of patients, from neonatal to adult.
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Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII) has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), and has begun a limited market release for the Stealth 360°™ Orbital PAD System. The Stealth ... Read Post
Mindray Medical International Limited (NYSE: MR) ("Mindray"), a leading developer, manufacturer and marketer of medical devices worldwide, announced that it has received 510(k) clearance from the United States Food and Drug Administ... Read Post
Vapotherm, the global leader in High Flow Oxygen Therapy products, has received 510(k) clearance from the Food and Drug Administration (FDA) for Precision Flow(TM), the first high flow humidification system to integrate gas blending... Read Post