Harmony Iq
The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events.
21manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Guangdong (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Shanghai Everpure Plastics Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
Showing 12 of 21. All 21 manufacturers in China registered for Light, Surgical, Accessories
Record
| Listed by | Black Diamond Video, Inc., United States |
|---|---|
| FDA product code | FTA |
| Device type | Light, Surgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-23 |
| Record revised | 2024-06-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Harmony iQ 2800 | Withdrawn | |
| Harmony iQ 3600 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspen® Flexible Light Handle Adapter | Aspen Surgical Products, Inc. | 290 |
| Litex | Litex Manufacturing, Inc. | 226 |
| DeRoyal | Deroyal Industries, Inc. | 215 |
| Aspen® Rigid Light Handle Adapter | Aspen Surgical Products, Inc. | 212 |
| Light, Surgical, Accessories | Maquet Gmbh | 72 |
| Medical Action Industries | Medical Action Industries, Inc. | 42 |
| Olympus | Gyrus Acmi, Inc. | 37 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 14 |
| Helion | Videomed SRL | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 13 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 8 |
| Aspen® Rigid Light Handle Cover | Aspen Surgical Products, Inc. | 6 |
Showing 12 of 74. All products under Light, Surgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133413 | 2014-01-07 |
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.