EML

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Chisel, Bone, Surgical

Device class

Class I (low risk)

Regulation

21 CFR 872.4565

Medical specialty

Dental

Adverse events (MAUDE)

1992: 1 · 2009: 4 · 2013: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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