13 results
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19ms
·
Sources: EU EUDAMED, US FDA
CAMPBRIDGE COMPUTRACE
FDA 510(k)
FDA Class 2
·Cardiovascular
AURADONICS
FDA UDI
AURADONICS INC.·00810033835681·EXTRAORAL LATEX ELASTICS 3/16" 8 oz. X-Hvy - AM...
SYRINGE 20ML 21G 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 7, 2019
Ultra Facial Toning System
FDA 510(k)
FDA Class 2
·Neurology
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 20ML 21G 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 22, 2019
SYRINGE 20ML 21G 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 22, 2019
XWIRE GUIDEWIRE
FDA Adverse Event
Other
·CONMED CORPORATION·Product code KOG·August 24, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PUMP MMT-508LUC EA INSULIN CH EN US LN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·August 10, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024