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 noted that the products are subject to detention and refusal of admission if they are offered for importation into the United States. Read More
There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing, but no deaths, the FDA said. Read More
The FDA said the blood lead tests “may provide falsely low results and may lead to health risks in special populations, such as young children and pregnant individuals.” Read More
The FDA said it has received “reports of pain and changes in the surrounding bone and soft tissue in people implanted with the Precice Stryde device.” Read More
The accusations centered around the company’s alleged failure to disclose serious adverse health events in connection with the premature depletion of the battery in certain models. Read More