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

BioSig Technologies CEO Interview: Novel EP Recording Device that Eliminates the Noise associated with Diagnostic Cardiac Electrophysiology

In a recent interview with CEOCFO Magazine, BioSig Technologies (OTCQB:BSGM) CEO, President & Director Gregory D. Cash discussed their proprietary...