7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLOOD CELL PROCESSOR MODEL 2 IBM 2991
FDA 510(k)
FDA Class 2
·Hematology
TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
SpineView X-Pac Expandable Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
CF RESECTOSCOPE INNER SHEATH
FDA Adverse Event
Injury
·GYRUS ACMI INC.·Product code FJL·April 7, 2014
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 13, 2007
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·September 26, 2012
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025