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Otoscope

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

1,936
Registered devices
25
Adverse events
1
Recalls
56
510(k) clearances

Devices with this code

ri-scope® L ophthalmoscope head L2 LED 3,5V, — Rudolf Riester GmbHDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPRVS-200, NIBP (Riester) + SpO2 (Masimo) + — Rudolf Riester GmbHDiagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPn.a. — Karl Storz GmbH & Co. KGDiagnostix™ — AMERICAN DIAGNOSTIC CORPWelch Allyn, Inc. — WELCH ALLYN, INC.mytaMed — Mytamed, Inc.Diagnostix™ — AMERICAN DIAGNOSTIC CORPWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Amico Diagnostic Station — Amico Diagnostic IncorporatedWelch Allyn, Inc. — WELCH ALLYN, INC.Diagnostix™ — AMERICAN DIAGNOSTIC CORPAmico Diagnostic Station — Amico Diagnostic IncorporatedDiagnostix™ — AMERICAN DIAGNOSTIC CORPWelch Allyn, Inc. — WELCH ALLYN, INC.Amico Diagnostic Station — Amico Diagnostic IncorporatedAdstation™ — AMERICAN DIAGNOSTIC CORPri-scope® L oto- L2 /ophthal. L2, LED/XL 3.5 V, — Rudolf Riester GmbHDiagnostix™ — AMERICAN DIAGNOSTIC CORP

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.