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Key Surgical Mr. Clear Anti-Fog

KEY SURGICAL, INC. · Model AF-031 · UDI-DI 00849771037859

OCT Prescription
1
510(k) clearances
182
Adverse events
2
Recalls
62
Facilities

Description

Key Surgical Mr. Clear Anti-Fog is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.

Recalls

DateFirmReason
2022-01-14Sunstar Americas, Inc.Product lacks premarket clearance.
2019-05-30Medline Industries, Inc.The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

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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.