85 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SONOLITH I-SYS LITHOTRIPER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROJAN CRYSTAL CLEAR LIQUID
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
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
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·April 29, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·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