3 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GoDirect Screw-Retaining Top Part Numbers: 4500-61
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·January 18, 2017
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013