Tag: 510(k) clearance

August 16, 2019

Profound Medical Receives FDA Clearance for TULSA-PRO®

Profound Medical (TSX:PRN, OTCQX:PRFMF) has announced it has received 510(k) clearance from the US Food and Drug Administration to market...
October 19, 2018

OrthoPediatrics Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

OrthoPediatrics (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance...
October 11, 2018

K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA Platform

K2M (NASDAQ:KTWO) a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, announced at...
August 14, 2018

BioSig Receives FDA 510(k) Clearance, Share Price Decreases

BioSig Technologies has had a successful first half of August, with its FDA clearance being just one of several steps...
August 14, 2018

BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System

BioSig Technologies (OTCQB:BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the...
July 27, 2018

Adherium Receives Additional U.S. FDA 510(k) Clearance for U.S. Consumer Launch of the Hailie™ Solution

Adherium (ASX:ADR) has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter sales of...
June 29, 2018

Apollo Endosurgery Receives Special 510(k) Clearance for OverStitch Sx Endoscopic Suturing System

Apollo Endosurgery (Nasdaq:APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that it...