IWS
6 FDA 510(k) clearances · Product code
182 daysmedian time to decision
354 days90th percentile
6clearances measured
FDA profile
- Official device name
- Shield, Eye, Radiological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Medical specialty
- Radiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COATED TUNGSTEN EYESHIELD (K945515) | Medtec, Inc. | 1995-06-19 |
| ROYAL MARSDEN GOLD GRAIN GUN (K940119) | Best Industries | 1994-12-30 |
| TUNGSTEN EYESHIELD (K943011) | Medtec, Inc. | 1994-12-23 |
| MED-GENESIS PATIENT LASER EYE SHIELD (K934459) | Med-Genesis, Inc. | 1994-02-22 |
| NUCLEAR ASSOCIATES GLASSERS (K934362) | Victoreen, Inc. | 1993-11-12 |
| RADIOLOGICAL PROTECTIVE EYE SHIELD (K920540) | Burkhart Roentgen Intl., Inc. | 1992-05-28 |
Track IWS automatically
Every clearance here is in the API, with alerts when new ones post.