MHW

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dressing, Compression

Device class

Class I (low risk)

Regulation

21 CFR 880.5075

Medical specialty

General Hospital

Flags

GMP exempt

Adverse events (MAUDE)

2004: 2 · 2005: 2 · 2006: 7 · 2007: 6 · 2008: 5 · 2013: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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