12 results
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51ms
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Sources: EU EUDAMED, US FDA
Edap Technomed Inc.
FDA registration
Edap Technomed Inc.·1 product·🇺🇸 United States
EDAP PROSTATRON
FDA Adverse Event
Malfunction
·EDAP TECHNOMED, INC.·Product code MEQ·September 29, 2000
PROSTATRON
FDA Adverse Event
Injury
·EDAP TECHNOMED, INC.·Product code MEQ·April 7, 2000
TUMT & PROSTATRON
FDA Adverse Event
Injury
·EDAP TECHNOMED, INC.·Product code MEQ·December 28, 2000
PROSTATRON
FDA Adverse Event
Injury
·EDAP TECHNOMED, INC.·Product code MEQ·March 22, 2000
TECHNOMED
FDA Adverse Event
Malfunction
·EDAP TECHNOMED, INC.·Product code MEQ·October 6, 1999
PROSTATRON
FDA Adverse Event
Injury
·EDAP TECHNOMED, INC.·Product code MEQ·May 2, 2001
PROSTATRON
FDA Adverse Event
Other
·EDAP TECHNOMED, INC.·Product code MEQ·December 29, 1998
FOCAL ONE HIFU SYSTEM
FDA Adverse Event
Injury
·EDAP TECHNOMED INC.·Product code PLP·March 5, 2026
PROSTATRON - TUMT
FDA Adverse Event
Injury
·EDAP TECHNOMED INC.·Product code MEQ·February 4, 1999
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
FDA Recall
Terminated
·Edap Technomed Inc.·Product code PLP·August 14, 2017
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
FDA Enforcement
Class II
·Terminated·Edap Technomed Inc.·November 1, 2017