8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Additively Manufactured Denture Resin
FDA 510(k)
FDA Class 2
·Dental
DAKOCYTOMATION ER/PR PHARMDX KIT
FDA 510(k)
FDA Class 2
·Hematology
E-CUBE 12
FDA 510(k)
FDA Class 2
·Radiology
VENTILATOR, CONTINUOUS, FACILITY USE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
OPTIFLUX F18NRE DIALYZER FINISHED ASSY
FDA Adverse Event
Injury
·OGDEN MFG·Product code FJI·July 19, 2013
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·January 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025