We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The agency observed that 4 of 12 complaints reviewed involved a device manufactured by the company getting stuck to the customer’s teeth and in some cases required professional dental care. Read More
There were numerous discrepancies between documented X-ray peak energy values in the collimator leakage test procedure and the production log. Read More
The budget request includes $100 million to advance the use of real-world experience to develop clinical data to expedite medical product development. Read More
The FDA issued Boca Raton, Florida based medical devicemaker Lexington International a Form 483 for conducting laser radiation safety testing and distributing a medical device without recording the laser output measurements. Read More