STERIS Corp. (NYSE: STE) has settled with the Food and Drug Administration, addressing the “violating device” status of the company’s System 1 liquid chemical sterilizer and fleshing out a transition ...
Infection prevention and decontamination technologies maker STERIS Corp. (NYSE: STE) lost $45 million in its fiscal first quarter, thanks to setting aside $110 million to cover a rebate program in a ...
The U.S. Food and Drug Administration has prohibited further distribution of a STERIS Corp. liquid chemical sterilization system, but its customers will have some recourse. As part of the consent ...
The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" ...
Steris Corp. (NYSE: STE) said it has reached an agreement with the U.S. Food and Drug Administration on its System 1 liquid chemical sterilization system, which the agency last December said Steris no ...
The Food and Drug Administration is warning medical facilities to stop using the Steris System 1 Processor because the product has been significantly modified and the FDA has not approved the modified ...
Steris Corp. has updated its widely used medical sterilization system and submitted the changes to the Food and Drug Administration for review. Getting approval to sell the new equipment could take a ...
Federal regulators have given Steris Corp. permission to start selling an accessory for its flagship product, but the approval would have had a bigger impact had it come sooner, according to a Steris ...
FDA this week told health facilities they have 18 months to switch from the STERIS System 1 to alternatives, three times longer than it recommended previously. STERIS Corp. continues to seek clearance ...
The FDA’s Office of Compliance has issued a letter to endoscope manufacturers regarding labeling on reusable medical devices that references the STERIS System 1 processor. The FDA notified healthcare ...
MENTOR, Ohio--(BUSINESS WIRE)-- STERIS Corporation (NYSE: STE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E ® Liquid Chemical ...