19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CODMAN INTRACRANIAL BOLT
FDA 510(k)
FDA Class 2
·Neurology
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·December 16, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
EASY-TEST CREATININE (CREA) ITEM NO. 19009
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Death
·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 12, 2017
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.,·Product code JOH·July 16, 2016
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 27, 2017
BD CONNECTA¿ STOPCOCKS
FDA Adverse Event
Injury
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·June 30, 2016
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·February 22, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 28, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014