Edap Technomed Inc.

FDA Regulatory Profile

Edap Technomed Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0049-2018, Class II) was initiated on August 14, 2017. Its most recent 510(k) clearance was granted on November 19, 2025.

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0049-2018Class IIAblatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation TAugust 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K251910Focal One®November 19, 2025
K172721FOCAL ONEJune 7, 2018
K172285Ablatherm FusionOctober 3, 2017
K153023Ablatherm Integrated ImagingNovember 6, 2015
K003529SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTISFebruary 12, 2001