Recall Of Cook Medical Catheters Labeled High-Risk Class I By FDA
The company has yanked from the market more than 37,000 of its catheters because there’s a chance they can break apart.
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The US FDA gave its highest risk designation to Cook’s recall of its Fixed Core Wire Guide.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.