Home › Device types › EWO
Audiometer
FDA product code EWO · Class 2 · Ear, Nose, Throat
1,177
Registered devices
63
Adverse events
5
Recalls
235
510(k) clearances
Devices with this code
OtoNova Pro Screener DP — OTODYNAMICS LIMITEDGN Otometrics A/S — Natus Medical Denmark ApSIntegrity Insert Earphones — Vivosonic IncBio-logic — NATUS MEDICAL INCORPORATEDN/A — ETYMOTIC RESEARCH, INC.Audhere Software — WAHTS HEARING LLCMeasure by Otometrics — Auditdata A/SRadioEar A/S — Interacoustics A/SEtymotic Research — ETYMOTIC RESEARCH, INC.Otoport/Otocheck Mini Printer — OTODYNAMICS LIMITEDOtoport Pro Advanced Clinical — OTODYNAMICS LIMITEDInsert Earphone PIEP — PATH medical GmbHN/A — ETYMOTIC RESEARCH, INC.RadioEar A/S — Interacoustics A/SRadioEar A/S — Interacoustics A/SBenson — MAICO Diagnostics GmbHCELLO — INVENTIS SRLDPOAE probe tips — OTODYNAMICS LIMITEDTremetrics — Diagnostic Group LLCOtoport Pro AABR instrument — OTODYNAMICS LIMITEDWAHTS — WAHTS HEARING LLCE-A-RTONE™ — 3M COMPANYOtoport Pro Docking Station — OTODYNAMICS LIMITEDN/A — ETYMOTIC RESEARCH, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2008-09-16 | Cardinal Health, Inc | GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Sp |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.