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CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Read More
Cook Medical is recalling 408,011 of its Beacon Tip Catheter in U.S. markets, due to complaints that the catheter tip may split or separate and could potentially enter the patient’s bloodstream. Read More