8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FIXATION PIN
FDA 510(k)
FDA Class 2
·Orthopedic
PRESAGE ST2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAVEX STABISIL
FDA 510(k)
FDA Class 2
·Dental
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·December 26, 2025
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·November 23, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014
VITEK® 2 AST-P612 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·June 12, 2017