LDG

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Kit, Earmold, Impression

Device class

Class I (low risk)

Regulation

21 CFR 874.3300

Medical specialty

Ear, Nose, Throat

Adverse events (MAUDE)

1994: 1 · 1998: 3 · 1999: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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