The FDA updated its safety alert concerning the Pentax ED-3490TK duodenoscope after Pentax identified a new risk with the ED-3490K duodenoscope. Here’s what you should know. 1. Pentax identified ...
More than 20 million gastrointestinal endoscopic procedures are performed each year in the United States. According to the American Society for Gastrointestinal Endoscopy (ASGE), the risk of infection ...
Please provide your email address to receive an email when new articles are posted on . The FDA has issued an update to its safety communication regarding the risk for infection associated with the ...
The FDA sent warning letters to three duodenoscope manufacturers — Olympus Corp., Fujifilm and Pentax — March 9 for failing to conduct mandatory postmarket surveillance studies into the efficacy of ...
The FDA has signed off on updated cleaning and operating instructions for Pentax Medical's video duodenoscope. The move comes as devicemakers face increased scrutiny after superbugs linked to the ...
The US Food and Drug Administration (FDA) has issued an updated safety communication on the ED-3490TK video duodenoscope from Pentax regarding a design problem that could increase the risk for patient ...
Please provide your email address to receive an email when new articles are posted on . The FDA has issued an update to its safety communication regarding the risk for infection associated with the ...
The Food and Drug Administration on Wednesday approved Pentax of America's new duodenoscope, which features a disposable distal cap to improve device cleaning and reprocessing. Duodenoscopes are ...
Device Features Sterile, Disposable Cap and Elevator to Reduce Contamination and Minimize Reprocessing Burdens MONTVALE, N.J.--(BUSINESS WIRE)--PENTAX Medical, a healthcare industry leader in ...
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