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Sentiero AuDX PRO
PATH medical GmbH · Model 8-04-16530 · UDI-DI 04260223143489
1
510(k) clearances
119
Adverse events
4
Recalls
58
Facilities
Description
Sentiero AuDX PRO Set: Content: 1. Sentiero Diagnostic device AN100098-AUP 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. TEOAE Software AN100109 7. DPOAE Software AN100110 8. FMDPOAE Software AN100536 9. DPHiRes Software AN100537 10. Software label printer AN100414 11. PC Patient Management Software AN100116 12. USB data cable AN100089 13. USB stick Bio-Logic AN100724-BL 14. Power supply Sentiero AN101013+AN100993-USA 15. Manual Bio-Logic AN100904-EN-BL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap |
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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.