EAJClass I
Apron, Leaded
21 CFR 892.6500 / Radiology
EAJ is the FDA product code for Apron, Leaded, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 25 recalls.
Classification record
- Product code
- EAJ
- Device name
- Apron, Leaded
- Regulation
- 21 CFR 892.6500
- Device class
- Class I
- Review panel
- Radiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 25
Clearances, product code EAJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1987 | 2 |
| 1991 | 1 |
| 1993 | 1 |
Applicants with the most clearances
Product code EAJ| Applicant | Clearances |
|---|---|
| E.M. Adams Co., Inc. | 2 |
| Bt Medical Co., Inc. | 1 |
| Mizuho Orthopedic Systems Inc | 1 |
| Rinn Dental Products | 1 |
| X-Tech, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Aadco Medical Inc.
- Alimed, LLC
- Barrier Technologies, LLC
- Burlington Medical LLC
- Dentimed Sao Joao
- Domico Med-Device, LLC
- Ekong Technology Co., Limited.
- Hospital & Homecare Imp. & EXP. Co., Ltd
- Infab, LLC.
- Jiangsu Yongfa Medical Equipment Technology Co., Ltd
- Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
- Mattes Instrumente GmbH
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
