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The FDA should exempt certain biologic grafts from its “sweeping proposed reclassification” of surgical mesh, Cook Biotech says in comments on a proposal to place mesh for transvaginal pelvic organ prolapse repairs in Class III. Read More
The FDA has rejected a call for a total ban on transvaginal mesh products, saying complete market withdrawal is not an appropriate way to deal with serious safety concerns linked to the devices. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with the company’s Renasys line of negative pressure wound treatment devices.
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The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, which is used with its Renasys line of negative pressure wound treatment devices. Read More
The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness by the government to crack down on illegal ads. Read More