4,194 results
·
61ms
·
Sources: EU EUDAMED, US FDA
USYSTEMS INVENIA GEN 2
FDA Adverse Event
Injury
·U-SYSTEMS, INC.·Product code PAA·October 19, 2018
INVENIA
FDA Adverse Event
Malfunction
·U-SYSTEMS INC·Product code PAA·March 3, 2016
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
FDA Recall
Terminated
·U-systems Inc·Product code PAA·May 16, 2013
*
FDA Adverse Event
Malfunction
·CHURCHILL MEDICAL SYSTEMS, INC. CUSTOM TRAY DIV.·Product code FMI·June 13, 2001
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·June 8, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 26, 2025
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 28, 2025
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 24, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 6, 2024
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·September 29, 2023
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
FDA Enforcement
Class II
·Terminated·U-systems Inc·July 3, 2013
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 15, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 17, 2022
DA VINCI SP
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·August 29, 2024
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·August 28, 2025
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 21, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 30, 2026
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 6, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 6, 2023
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 18, 2025