Recall Of Cordis Stent System High-Risk Class I, US FDA Says
The Precise PRO Rx US Carotid System was yanked from shelves because the device could separate during use.
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Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.
The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.
A May recall of 25,000 Super Torque MB Angiographic Catheters with Radiopaque Marker Bands was given the high-risk classification by the US agency on 22 September.