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USA Elite

Gyrus ACMI, LLC · Model S-AWE-S · UDI-DI 00821925038653

FFY Prescription
2
510(k) clearances
10
Adverse events
0
Recalls
101
Facilities

Description

ACMI USA Elite System and USA Series Self Sealing Seals (Black) (6/PK)

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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.