9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
FDA 510(k)
FDA Class 2
·Neurology
Fixtemp Cement
FDA 510(k)
FDA Class 2
·Dental
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·November 11, 2014
ATLAS PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
BD DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 6, 2018
DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 20, 2018