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TULSA-PRO
Profound Medical Inc · Model 103708 · UDI-DI 07540281000090
PLP
Prescription
1
510(k) clearances
33
Adverse events (1 deaths)
1
Recalls
8
Facilities
Description
Cable - FB to PSIB, 40 FT
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.