HarmonyAIR
The High Density Light Handle Camera Module is used with the Harmony LED and HarmonyAIR M-Series Lighting Systems.
Who Else Makes It
Concentrated in Jiangsu (10), Guangdong (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shanghai Suoguang Visual Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Showing 12 of 22. All 22 manufacturers in China registered for Camera, Surgical And Accessories
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | KQM |
| Device type | Camera, Surgical And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2026-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G-Series Camera | In distribution | |
| M-Series Suspension | In distribution | |
| A-Series Camera | In distribution | |
| A-Series Camera | Withdrawn | |
| M-Series Camera | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Radiance | NDS Surgical Imaging, LLC. | 129 |
| Accu-Beam | Transamerican Technologies International | 114 |
| Barco | Barco, Inc | 89 |
| Conmed | ConMed Corporation | 59 |
| EndoVue | NDS Surgical Imaging, LLC. | 50 |
| Sony | Sony Corporation | 42 |
| CuratOR | Eizo Corporation | 38 |
| FSN | Foreseeson Custom Displays, Inc. | 25 |
| ILO | ILO Electronic Gmbh | 25 |
| Camera, Surgical And Accessories | Pentax of America, Inc. | 24 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 24 |
| Tidishield | Tidi Products, LLC | 22 |
Showing 12 of 190. All products under Camera, Surgical And Accessories
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-05-23 | Class II | Process control | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6×0 (adapter) components the incorrect configuration file was used. | 10 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.