13 results
·
35ms
·
Sources: EU EUDAMED, US FDA
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
FDA 510(k)
FDA Class 2
·Anesthesiology
PHILIPS ANGIOPRO
FDA 510(k)
FDA Class 2
·Radiology
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Death
·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016
SYNCHRON (R) SYSTEMS CREATININE REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGX·July 2, 2011
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
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 6, 2010
LAP-BAND AP ADJUSTABLE GASTRIC BANDIN SYSTEM (LARGE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·January 10, 2013
PLATE,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·July 4, 2014