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.
Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter. Read More
Boston Scientific is recalling 600 units of its RotaWire Elite guidewire and wireClip Torquer guidewire manipulation device, components of the Rotablator rotational atherectomy system, because they may break and separate, causing serious injury or death. Read More
In the wake of more than 5,000 adverse events reports, including four deaths, the FDA says it plans to communicate next steps it plans to take on Bayer’s Essure contraceptive implant by the end of next February. Read More
Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter. Read More
Rep. Tim Murphy (R-Pa.) questions whether Johnson & Johnson and Brigham & Women’s Hospital failed to notify the FDA of risks posed by the devices. Read More
Citing continued violations of a 2007 consent decree, the FDA has ordered Custom Ultrasonics to recall all 2,800 automated endoscope reprocessors in hospitals and outpatient clinics in the U.S. Read More
Efforts to remove Bayer’s implantable contraceptive Essure from the market continue to mount, with the introduction of a House bill that would require the FDA to withdraw premarket approval of the device. Read More
The FDA is advising healthcare professionals to strictly follow the instructions for use for cranial perforators with automatic clutch mechanisms following reports of more than 200 injuries related to their use. Read More