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U-Sculpt Power Transducer,
SYNERON MEDICAL LTD · Model FG71531 · UDI-DI 07290109952147
10
510(k) clearances
216
Adverse events
1
Recalls
17
Facilities
Description
U-Sculpt Power Transducer, Packaged, UltraShape Power
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-30 | RoyalVibe Health Ltd. | Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of cust |
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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.