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Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901001 · UDI-DI 00732094186338
EWO
Prescription
10
510(k) clearances
65
Adverse events
5
Recalls
65
Facilities
Description
Welch Allyn Single Use Ear Tip Starter Kit for OAE Hearing Screener; Qty. 10 each: 7 mm to 15 mm, 3-5 mm and 5-8 mm Flanged; Qty. 30 Probe Tubes; Qty. 140
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. Split Screen Field Cor |
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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.