6 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.
FDA Recall
Terminated
·Innovative Neurotronics, Inc.·Product code GZI·August 6, 2008
Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
FDA Enforcement
Class II
·Terminated·SynCardia Systems Inc.·January 9, 2013
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014