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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901035 · UDI-DI 00732094145014

EWO Prescription
10
510(k) clearances
63
Adverse events
5
Recalls
65
Facilities

Description

Welch Allyn AudioScope 3 Screening Audiometer; Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 110-130 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-B

Recalls

DateFirmReason
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26PATHAffected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16Cardinal Health, IncGSI 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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Data 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.