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Sonalleve

Profound Medical Inc · Model 451000080766 · UDI-DI 07540281000236

QND Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

SONALLEVE MR-HIFU V2 ACHIEVA 1.5T

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.