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... 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
IMPLANET: Successful First Surgical Procedures with New Jazz Lock® Implant
IMPLANET, a medical technology company specializing in vertebral and knee-surgery implants, today announces the successful results of the first surgical...
August 30, 2016