8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K2M Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
INBODY
FDA 510(k)
FDA Class 2
·Cardiovascular
ABL837 FLEX ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 12, 2025
COULTER® ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 20, 2013
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FPA·September 26, 2014
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·July 22, 2011
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·August 21, 2023