Med-Syringe
10cc Med Syringe L/L Dark Green Contrast
7manufacturers in China registered for this device type
16catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K911732 |
| Record published | 2016-09-09 |
| Record revised | 2026-05-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25 |
| Distribution end date | 2024-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 382011 | 10cc | In distribution |
| 382001 | 10cc | In distribution |
| 382051 | 10cc | In distribution |
| 382021 | 10cc | In distribution |
| 382003 | 10cc | Withdrawn |
| 382022 | 10cc | Withdrawn |
| 382023 | 10cc | Withdrawn |
| 382031 | 10cc | Withdrawn |
| 382055 | 10cc | Withdrawn |
| 382006 | 10cc | Withdrawn |
| 382052 | 10cc | Withdrawn |
| 382015 | 10cc | Withdrawn |
| 382025 | 10cc | Withdrawn |
| 382013 | 10cc | Withdrawn |
| 382016 | 10cc | Withdrawn |
| 382061 | 10cc | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
| Leica FL800 ULT | Leica Microsystems (Schweiz) AG | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 1008 syringes | 2007-04-19 |
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 160 kits | 2007-04-19 |
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 203 syringes | 2007-04-19 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 34 syringes | 2007-04-19 |
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 700 syringes | 2007-04-19 |
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 2752 syringes | 2007-04-19 |
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.