EAJ
6 FDA 510(k) clearances · Product code
58 daysmedian time to decision
86 days90th percentile
6clearances measured
FDA profile
- Official device name
- Apron, Leaded
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1993: 1 · 1997: 75 · 1998: 3
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 |
|---|---|---|
| LEAD APRON (K931269) | Bt Medical Co., Inc. | 1993-06-02 |
| RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR (K913621) | Rinn Dental Products | 1991-09-27 |
| X-RAY APRON (K870563) | X-Tech, Ltd. | 1987-02-19 |
| LEAD APRON CADDY (K870103) | Orthopedic Systems, Inc. | 1987-01-21 |
| THYROID PROTECTIVE COLLAR (K832602) | E.M. Adams | 1983-09-29 |
| LEADED X-RAY APRON (K832601) | E.M. Adams | 1983-09-29 |
Track EAJ automatically
Every clearance here is in the API, with alerts when new ones post.