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Penguin ENT Scope model

OPCOM INC. · Model CP1313F6 · UDI-DI 04711099370047

ERA

510(k) clearances

Adverse events

Recalls

234

Facilities

Description

Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.

Recalls

Date	Firm	Reason
2025-05-09	Baxter Healthcare Corporation	The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to ex

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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.