September 2015

Implanet wins expanded FDA 510(k) clearance for Jazz band device

by Fink Densford for

French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems.

The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures.  The device is cleared for spinal trauma surgeries, spinal reconstructive surgeries and spinal degenerative surgeries, according to...

Ceterix Orthopaedics wins FDA 510(k) clearance for NovoStitch Plus

by Fink Densford for

Ceterix Orthopaedics said today it won FDA 510(k) clearance for its NovoStitch Plus meniscal repair system designed for patients with meniscal tearing.

The device is a next-generation version of the company’s NovoStitch, designed to treat a variety of different meniscal tears, the Menlo Park, Calif.-based company said.

“The main difference is the NovoStitch Plus has a cartridge-based system and the cartridge has an...

kBLASTER update September 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from August 2015 and FDA 510(k) splash pages for 510(k)s clearances in September 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

With nearly 62,000 510(k)...

Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite

by Philips

ANDOVER, MA – Reinforcing its commitment to improving diagnostic confidence through innovation, Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Spectral Diagnostic Suite (SpDS). Philips SpDS is a set of advanced visualization and analysis tools designed for the Philips IQon Spectral CT to...

Eko gets greenlight from FDA for digital stethoscope

By Stephanie Baum for

Medical device company Eko got the greenlight from the FDA with a 510(k) clearance for its Class 2 medical device — digital stethoscope Eko CORE, according to a company statement. It wirelessly streams heart sounds to a smartphone app and integrates heart sounds directly into the patient’s electronic health record. The goal is to support physicians...

Bovie Medical Receives FDA 510(k) Clearance for New J-Plasma® Pistol Grip Configurations

by Business Wire

CLEARWATER, Fla.--()--Bovie Medical Corporation (“Bovie” or the “Company”) (NYSE:BVX), a maker of medical devices and supplies and the developer of J-Plasma®, a patented new surgical product, announced today that it has received FDA 510(k) approval for six new hand piece configurations that expand its J...