56 results
·
37ms
·
Sources: EU EUDAMED, US FDA
JELTEMP
FDA 510(k)
FDA Class 2
·Dental
Progenikine Concentrating System 25 mL System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NBM-200MP PULSE OXIMETRY DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·February 28, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 26, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 22, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·November 28, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·April 18, 2023
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 23, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·May 8, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 25, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 6, 2013
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·February 15, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 27, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 13, 2026
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 30, 2026
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·September 25, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 15, 2025
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·April 22, 2026