5 results
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48ms
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Sources: EU EUDAMED, US FDA
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code EWO·September 16, 2008
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Recall
Terminated
·Gsi Group Inc·Product code DSF·December 2, 2015
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Enforcement
Class II
·Terminated·Gsi Group Inc·March 2, 2016
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