12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ICAN CYLINDRICAL SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CTL BODY / SPINE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
FDA 510(k)
FDA Class 2
·Dental
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
DXTEND STAND PE CUP D38 + 3MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWS·December 1, 2010
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·January 14, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014