FDA Device Intelligence
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Otoscope

FDA product code ERA · Class 1 · Ear, Nose, Throat

1,903
Registered devices
23
Adverse events
1
Recalls
56
510(k) clearances

Devices with this code

BEAR — Mytamed, Inc.Diagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPEliteVue oto/ophthal. set,LED, 3.5V, with C-handle — Rudolf Riester GmbHWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Adstation™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPWelch Allyn, Inc. — WELCH ALLYN, INC.Firefly Global — Firefly GlobalWelch Allyn, Inc. — WELCH ALLYN, INC.Prosidio — Prosidio LLCDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPzumax — Zumax Medical Co., LTDX CHANGE SYSTEM SL-MAGNIFIER — Heine Optotechnik GmbH & Co. KG

Recent recalls

DateFirmReason
2025-05-09Baxter Healthcare CorporationThe replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can le

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.