FDA Device Intelligence
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Elastomer, Silicone Block

FDA product code MIB · Class 2 · Ear, Nose, Throat

1,037
Registered devices
187
Adverse events
3
Recalls
45
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-09-26DSAART LLCManufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.
2025-09-26DSAART LLCManufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.
2025-09-26DSAART LLCManufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.

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