7 results
·
49ms
·
Sources: EU EUDAMED, US FDA
ULTRASOUND AI INC.
FDA registration
ULTRASOUND AI INC.·1 product·🇺🇸 United States
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·June 29, 2022
ELLIPS FX PHACO HANDPIECE
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code HQC·June 29, 2022
VERITAS ADVANCED INFUSION PACK
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·June 6, 2023
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
FDA Recall
Terminated
·Caption Health·Product code QIH·May 19, 2021
VERITAS ADVANCED INFUSION PACK
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·October 24, 2025
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices