5 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·March 1, 2021
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·February 28, 2024
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
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