17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Curiteva Porous PEEK Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
Arterys MICA
FDA 510(k)
FDA Class 2
·Radiology
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JIX·September 3, 2011
DREAMWIRE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·July 18, 2013
NONTEMPLATE ALIGNER ARCH
FDA Adverse Event
Injury
·DENTSPLY SIRONA ORTHODONTICS INC.·Product code NXC·November 25, 2024
NONTEMPLATE ALIGNER ARCH
FDA Adverse Event
Injury
·DENTSPLY SIRONA ORTHODONTICS INC.·Product code NXC·November 19, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025