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High Intensity Ultrasound System For Prostate Tissue Ablation
FDA product code PLP · Class 2 · Gastroenterology, Urology
71
Registered devices
33
Adverse events
1
Recalls
13
510(k) clearances
Devices with this code
TULSA-PRO — Profound Medical IncSonasource — FOCUS SURGERY INCEXABLATE — INSIGHTEC LTDAblatherm Integrated Imaging — EDAP-TMS FRANCETULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncSonablate — FOCUS SURGERY INCTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncTULSA-PRO — Profound Medical IncSonablate Insertion Pack — FOCUS SURGERY INCTULSA-PRO — Profound Medical IncFocalPak — EDAP-TMS FRANCEEXABLATE PROSTATE Treatment master kit for V2.2 — INSIGHTEC LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-14 | Edap Technomed Inc. | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Inte |
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