82 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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GE Healthcare Definium 5000/5220493-2 X-Ray System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAC·September 26, 2012
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·October 24, 2012