The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.
A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads.
The use of such devices could result in patient injury or even death.
OPEQ is an important step in the center’s modernization of business processes.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
Manufacturers of the surgical mesh devices have not provided reasonable assurances of safety and effectiveness, according to the agency.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
This new pathway is a considerable change for the medical device industry.
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.