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Audiometer
FDA product code EWO · Class 2 · Ear, Nose, Throat
1,209
Registered devices
74
Adverse events
5
Recalls
235
510(k) clearances
Devices with this code
RadioEar A/S — Interacoustics A/SKUDUwave — EMOYODOTNETZA (PTY) LTDSiemens — Ws Audiology Usa, Inc.Otoport/Otocheck Mini-Printer Cable — OTODYNAMICS LIMITEDGN Otometrics A/S — Natus Medical Denmark ApSRadioEar A/S — Interacoustics A/SOtometrics — Natus Medical Denmark ApSN/A — ETYMOTIC RESEARCH, INC.Siemens — Ws Audiology Usa, Inc.Siemens — Ws Audiology Usa, Inc.RadioEar A/S — Interacoustics A/SUnity 4 / Measure — Auditdata A/SWelch Allyn, Inc. — WELCH ALLYN, INC.FOAM large TEOAE probe tips — OTODYNAMICS LIMITEDRadioEar A/S — Interacoustics A/SGN Otometrics A/S — Natus Medical Denmark ApSOtoport Charger V2 — OTODYNAMICS LIMITEDN/A — ETYMOTIC RESEARCH, INC.Patient Response Button — PATH medical GmbHEar Tip IT-01 Pack/100 pcs. — PATH medical GmbHDD45-300 Headphones with Easy Adjust Headband — INTELLIGENT HEARING SYSTEMS CORP.Bone Conductor BC-2LD — PATH medical GmbHOscilla — Inmedico A/SNatus — NATUS MEDICAL INCORPORATED
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 |
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