Brandon Smith

Brandon Smith

Knobbe Martens

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First Thrombectomy Device Cleared for Pulmonary Embolisms

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment...more

6/8/2018  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Innovation , Medical Devices , Pharmaceutical Industry

FDA Issues Draft Guidance for the Use of UHMWPE in Orthopedic Devices

On February 12, 2016, the FDA issued draft guidance for the use of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The draft guidance is open for public comment for the next 90 days. According to the...more

3/30/2016  /  510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices
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