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The FDA is accusing a medical devicemaker of neglecting to report five cases of radiation leakage from its products and other reporting violations, according to a 10-observation Form 483. Read More
More federal regulators are knocking on Theranos’ door, keen on getting answers to questions about staff qualifications and improper review of patient test results. Read More
Explosion fears have prompted the FDA to warn facilities and consumers not to use one of OxySure Therapeutic’s portable emergency oxygen systems. Read More
The FDA has slammed Advanced Vision Science for potentially distributing intraocular lenses in the U.S. that were rejected for the Japanese market. Read More
The FDA has labeled the recall of Cook Medical’s single lumen central venous catheters and pressure monitoring sets and trays as Class 1, meaning it could cause serious injury or death. Read More