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hearX
HEARX GROUP (PTY) LTD · Model hearScope · UDI-DI 00860003469828
10
510(k) clearances
23
Adverse events
1
Recalls
234
Facilities
Description
hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-09 | Baxter Healthcare Corporation | The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to ex |
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Get your free API keyRead the docsData 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.