42 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AG-CLASSIC
FDA 510(k)
FDA Class 2
·Anesthesiology
HOME CARE JELLY
FDA 510(k)
FDA Class 2
·Neurology
PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 29, 2021
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 27, 2024
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 6, 2020
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
SETROX S 53
FDA Adverse Event
Death
·BIOTRONIK SE & CO. KG·Product code NVZ·April 22, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 25, 2022
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·January 26, 2024
CAPIOX FX HOLLOW FIBER OXYGENATOR WITH HARDSHELL RESERVOIR, ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 10, 2023
CAPIOX FX25
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·July 18, 2023
CAPIOX FX15 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 3, 2025
CAPIOX CUSTOM PACK
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DTZ·June 10, 2023
CAPIOX CUSTOM PACK
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 10, 2023
CAPIOX FX15 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 25, 2023
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 23, 2022
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2022
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 13, 2024