Tag: 510(k)
January 22, 2018
United Health Products Issues FDA Update
United Health Products (OTCPK:UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today...
December 6, 2017
How Do Medical Devices Get Approved?
We examine how the FDA classifies, regulates and approves medical devices. September 11, 2017
EDAP Announces Filing of New 510(k) Application
EDAP TMS announced the submission of a new 510(k) application for its Focal One device, including an updated clinical section... July 31, 2017
EDAP Files 510(k) Application for Ablatherm Fusion Device
EDAP TMS SA submitted a 510(k) application for their Ablatherm Fusion device. February 21, 2017
CriTech Research Concludes Software Remediation on SmartScan™ Software
Imaging3, Inc. (OTCQB:IGNG) announced today that, after several months of verification and validation, CriTech Research Inc. has completed its remediation... October 21, 2016
Vascular Solutions Receives 510(k) Clearance for Fluent™ Inflation Device
Vascular Solutions today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Fluent... September 14, 2016