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Merocel®

MEDTRONIC XOMED, INC. · Model 400850 · UDI-DI 20681490105723

OCT Prescription
10
510(k) clearances
181
Adverse events
2
Recalls
61
Facilities

Description

SOLUTION 400850 10PK ANTI-FOG

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.