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

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...