HQM

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Keratoprosthesis, Permanent Implant

Device class

Class II (moderate risk)

Regulation

21 CFR 886.3400

Medical specialty

Ophthalmic

Flags

Implant

Adverse events (MAUDE)

1994: 1 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free