7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIRCULATING IMMUNE COMPLEXES CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Scepter Mini Occlusion Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 10, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 5MAX
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·December 20, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2010
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017