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Go Hearing

HEARX GROUP (PTY) LTD · Model Go Ultra - Gray - BTE - WAG Online - CASE · UDI-DI 10810153660054

QUG
0
510(k) clearances
13
Adverse events
1
Recalls
90
Facilities

Description

Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE

Recalls

DateFirmReason
2025-04-25HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manu

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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.