The FDA announced today that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall. The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the […]
Applied Medical Technology
Novation cuts new deals with medical device giants
Covidien’s SpiderFX wins FDA clearance | Regulatory Roundup
Covidien (NYSE:COV) landed 510(k) clearance for its SpiderFX system to treat severely calcified lesions in the lower extremities.
The Mansfield, Mass.-based med-tech titan’s system has been on the European market since 2005 and is currently the only embolic protection device indicated for use in the lower extremities in the U.S.
KCI to withdraw from patent beefs, Applied Medical wins over Covidien, Whistleblowing doc fired from Northwestern | MassDevice.com +3
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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BSX will pay big to the DOJ, Covidien loses bid in torcar war against AMR, Mela Sciences shares surge on FDA approval | MassDevice.com +3
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with Massdevice +3.
Feeding tube maker Applied Medical Technology gets FDA warning letter
Feeding tube manufacturer Applied Medical Technology received a warning letter from the U.S. Food and Drug Administration for manufacturing and design issues at its suburban Cleveland location.
The FDA cited seven specific violations it found in an April inspection of the medical device company’s Brecksville, Ohio, manufacturing facility.