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UNITRON

Unitron Hearing Division · Model 076-5033-T809070 · UDI-DI 00698764597463

OSM
1
510(k) clearances
673
Adverse events
0
Recalls
81
Facilities

Description

uDirect 3 BTE Box (Swiss made)

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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.