2 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Enforcement
Class II
·Terminated·superDimension, Inc·July 18, 2012
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020