HQH
6 FDA 510(k) clearances · Product code
106 daysmedian time to decision
298 days90th percentile
6clearances measured
FDA profile
- Official device name
- Eye, Artificial, Non-Custom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.3200
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1992: 8
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
| Record | Firm | Date |
|---|---|---|
| ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538) | Robert B. Scott Ocularists of Florida, Inc. | 1995-06-26 |
| CUSTOM ARTIFICIAL HUMAN EYES (K945270) | Daniel T Acosta | 1995-05-30 |
| CUSTOM OCULAR PROSTHESIS (K946226) | Frank Tanaka, Ocularist, Inc. | 1995-03-22 |
| THE NISSEL ARTIFICIAL EYE (K923167) | Nissel , Ltd. | 1992-09-02 |
| EYE ARTIFICIAL CUSTOM (K904962) | Midwest Eye Laboratories, Inc. | 1991-08-30 |
| SCLERAL POWDER (K791923) | Ocularists , Ltd. | 1980-01-10 |
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Every clearance here is in the API, with alerts when new ones post.