HQJ
5 FDA 510(k) clearances · Product code
42 daysmedian time to decision
84 days90th percentile
5clearances measured
FDA profile
- Official device name
- Implant, Absorbable, (Scleral Buckling Methods)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3300
- Medical specialty
- Ophthalmic
- Flags
- Implant
- Adverse events (MAUDE)
- 1999: 29 · 2000: 3 · 2001: 3 · 2002: 1 · 2003: 1 · 2006: 2
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 |
|---|---|---|
| TITAN AIR SPECTACLE FRAME (K896350) | Acces Intl. Eyewear | 1989-12-18 |
| LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD (K884362) | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| LABTICIAN RETINAL IMPLANTS (K875014) | Labtician Products, Inc. | 1988-02-26 |
| MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK (K831773) | Bcd Products, Inc. | 1983-08-16 |
| IMPLANT, SILICONE AND TANTALUM (K760550) | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
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Every clearance here is in the API, with alerts when new ones post.