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Cellfina System Disposable Tray

Ulthera, Inc. · Model CK1 rev M · UDI-DI 00840763100766

OUP
1
510(k) clearances
79
Adverse events
1
Recalls
16
Facilities

Recalls

DateFirmReason
2016-11-14Ulthera IncIt was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the proce

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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.