Product code HNX
- Device name
- Depressor, Orbital
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04547451339212 | INAMI | INAMI & CO., LTD. | 2026-01-29 |
| 04547451339045 | Inami | INAMI & CO., LTD. | 2025-12-05 |
| 04058935013394 | Depressor Scleral Flynn | Bausch & Lomb GmbH | 2025-10-26 |
| 00757770524914 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770500444 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770498765 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770483235 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00194613011604 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| G412DP20600 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| 03700483625857 | ONE | MORIA SA | 2023-12-28 |
| 03700483602612 | ONE | MORIA SA | 2023-12-28 |
| 03700483611287 | ONE | MORIA SA | 2023-12-28 |
| 03700483620159 | ONE | MORIA SA | 2023-12-28 |
| 03700483625697 | ONE | MORIA SA | 2023-12-28 |
| 03700483625734 | ONE | MORIA SA | 2023-12-28 |
| 03700483625772 | ONE | MORIA SA | 2023-12-28 |
| 03700483625819 | ONE | MORIA SA | 2023-12-28 |
| 00810123481736 | Vortex Surgical Inc | Vortex Surgical, Inc. | 2023-02-01 |
| 00810123481699 | Vortex Surgical Inc | Vortex Surgical, Inc. | 2023-02-01 |
| 00810123481705 | Vortex Surgical Inc | Vortex Surgical, Inc. | 2023-02-01 |
| 00810123481712 | Vortex Surgical Inc | Vortex Surgical, Inc. | 2023-02-01 |
| G006DS30024180 | DRYSDALE NUCLEUS MANIPULATOR AND HOOK | DAUD JEE MFG. CO | 2022-12-12 |
| 54026704801942 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704801944 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704801937 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 35055186208340 | Malosa Medical | Beaver-Visitec International, Inc. | 2022-02-19 |
| 00810799039439 | Stephens Instruments | KRISHNA IMPORTS INC | 2020-09-23 |
| 00810799039415 | Stephens Instruments | KRISHNA IMPORTS INC | 2020-09-23 |
| 10886705016334 | FMS | Medos International Sàrl | 2015-09-01 |
| 10886705016310 | FMS | Medos International Sàrl | 2015-09-01 |