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USA Elite

Gyrus ACMI, LLC · Model REXEAWE · UDI-DI 00821925008168

FEC Prescription
1
510(k) clearances
44
Adverse events (1 deaths)
0
Recalls
13
Facilities

Description

USA Elite System Accessory Working Element

Query this across every FDA database — by API.

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.