International Medical Devices Database

Manufacturer Address
Edap Technomed Inc., 5321 Industrial Oaks Blvd Ste 110, Austin TX 78735-8823
Manufacturer Parent Company (2017)
EDAP TMS SA
Source
USFDA
1 Event
- Recall of Ablatherm Integrated Imaging device

One device in the database

Ablatherm Integrated Imaging device

Model / Serial
Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Product Description
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation || Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Edap Technomed Inc.

One device in the database

Ablatherm Integrated Imaging device