June 2016

NDS receives FDA 510(k) clearance for embedded wireless video receiver in Radiance Ultra displays

by PR Newswire

SAN JOSE, Calif., June 27, 2016 /PRNewswire/-- NDS today announced it has received FDA 510(k) clearance for an embedded wireless HD-video receiver to be integrated into an endoscopy display. The ZeroWire® G2 wireless technology solution from NDS, also available as an external unit, will now be design engineered into the new Radiance® Ultra series of premium endoscopy displays as an option within the display enclosure.

By embedding the...

kBLASTER update June 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from May 2016 and FDA 510(k) splash pages for 510(k)s clearances in June 2016. 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).  

Leverage ...

Masimo Announces 510(k) Clearance for O3™ Regional Oximetry

by Business Wire

IRVINE, Calif.--()--Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for O3™ regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure...

Noxilizer wins 510(k) clearance for NO2 sterilization of medical device

by Fink Densford for Medical Design and Outsourcing

Novel sterilization firm Noxilizer on Wednesday touted the FDA 510(k) clearance of a device which is terminally sterilized using the company’s nitrogen dioxide sterilization process.

The Baltimore, Md.-based company touts NO2 sterilization as “unique” as it sterilizes at low temperatures, between 10-30°C, and functions without a vacuum or humidity. Noxilizer says those aspects of the NO2 based sterilization make it ideal for temperature sensitive medical devices and biotech drugs.

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