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The advertisement failed to mention contraindications for the product, including acute pelvic inflammatory disease or current behavior suggesting a high risk of pelvic inflammatory disease. Read More
“EVD catheters are used in combination with a variety of EVD systems for external drainage of cerebrospinal fluid to manage elevated intracranial pressure… Read More
The lab manager told the investigator the firm had no procedure requiring the evaluation of all device complaints in order to figure out if the related event should be reported to the FDA. Read More
“Kickbacks to doctors can alter or compromise their judgment about the medical care and services to provide to patients, and can increase healthcare costs,” said Manhattan U.S. Attorney Geoffrey Berman. Read More
The devicemaker also received manufacturing materials from a supplier that was not found on its approved supplier list, an issue the agency said was a recurring observation. Read More
“Bioactive nano-texture created by ANAB treatment has been shown to improve tissue integration and inhibit pathogen adhesion to the surfaces of implantable medical devices,” the company said. Read More
[The employee], who was born with one kidney and an under-formed bladder, worked at the devicemaker’s Greenwood plant and was allegedly fired after missing several shifts due to health issues caused by her disabilities. Read More
The system offers new features, including an interface optimized for smartphones and tablets, as well as an online mobile patient health survey that is done in the doctor’s office. Read More