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EXABLATE PROSTATE Treatment master kit for V2.2
INSIGHTEC LTD · Model PROSTATE WATERLESS MASTER KIT FOR 5 TREATMENTS (FDA/NON-CE) · UDI-DI 07290019402268
PLP
Prescription
10
510(k) clearances
33
Adverse events (1 deaths)
1
Recalls
8
Facilities
Description
Prostate v2.2 single use master kit for 5 treatments
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 Integrated Imagining dev |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.