Product code IWS
- Device name
- Shield, Eye, Radiological
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.6500
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945515 | COATED TUNGSTEN EYESHIELD | Medtec, Inc. | 1995-06-19 |
| K940119 | ROYAL MARSDEN GOLD GRAIN GUN | Best Industries | 1994-12-30 |
| K943011 | TUNGSTEN EYESHIELD | Medtec, Inc. | 1994-12-23 |
| K934459 | MED-GENESIS PATIENT LASER EYE SHIELD | Med-Genesis, Inc. | 1994-02-22 |
| K934362 | NUCLEAR ASSOCIATES GLASSERS | Victoreen, Inc. | 1993-11-12 |
| K920540 | RADIOLOGICAL PROTECTIVE EYE SHIELD | Burkhart Roentgen Intl., Inc. | 1992-05-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840331296341 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296488 | Bolle | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296471 | Bolle | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296464 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296457 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296440 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296433 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296426 | Haven | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296419 | Haven | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296402 | Haven | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296396 | Haven | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296389 | Bomber | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296372 | Bomber | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296365 | Bomber | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296358 | Bomber | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296334 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296327 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 00840331296310 | Nike | BURLINGTON MEDICAL, LLC | 2024-04-12 |
| 08904333250601 | UniRay | UNIRAY MEDICAL LLP | 2023-02-18 |
| 00840348524895 | AADCO | AADCO MEDICAL, INC. | 2022-12-14 |
| 10850017419336 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419329 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419084 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419077 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419060 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419053 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419046 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 10850017419039 | Opti-Gard | DUPACO, INC. | 2020-10-30 |
| 08710103632122 | Philips Zoom | Discus Dental, LLC | 2020-09-23 |
| 30697660002256 | Laser kit | Oculo-Plastik Inc | 2019-11-07 |