85 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
3DFIS, MODEL IES-FL-101
FDA 510(k)
FDA Class 2
·Radiology
AMMONIA ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Death
·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 3, 2018
BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·September 15, 2016
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 10, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 19, 2017
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017
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® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017
PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·July 10, 2017
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017