6 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k)
FDA Class 2
·Microbiology
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k)
FDA Class 2
·Microbiology
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
FDA Enforcement
Class II
·Terminated·Intelerad Medical Systems·August 27, 2014
Synaptive Trackable Suction Set Standard and Malleable
FDA Enforcement
Class II
·Terminated·Synaptive Medical Inc·July 7, 2021
IAFP BILE ESCULIN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
IAFP BILE ESCULIN AZIDE AGAR
FDA 510(k)
FDA Class 1
·Microbiology