11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aptima SARS-CoV-2 Assay
FDA 510(k)
FDA Class 2
·Microbiology
omni TRAX Active Patient Tracker
FDA 510(k)
FDA Class 2
·Radiology
INTEGRITY, MODEL V500
FDA 510(k)
FDA Class 2
·Neurology
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·March 26, 2025
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 1, 2011
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 11, 2014
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·August 18, 2011
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·July 23, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2011
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 28, 2011