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N/A

GaleMed Xiamen Co., Ltd. · Model AD0028 · UDI-DI 06923980103674

BYP

510(k) clearances

Adverse events (1 deaths)

Recalls

168

Facilities

Description

Mouth Piece, 13M

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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.