There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
The device will no longer be available after December 31, 2018.
When ferromagnetic objects enter an MRI suite, they become a serious hazard – here’s how to prevent them from getting in.
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.
How software is changing the legal landscape for medical device manufacturers.
FDA has not approved the device for the procedure, called transvascular autonomic modulation.
If you ignore the Federal FD&C Act, you’re tempting fate.
Money should never be a higher priority than safety and efficacy.
The agency says there’s not enough evidence to demonstrate that there’s reasonable assurance of safety and effectiveness.