Data / Medical devices / China / Shenzhen Boon Medical Supply Co., Ltd.
Shenzhen Boon Medical Supply Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Shenzhen Boon Medical Supply Co., Ltd. is registered with the FDA (registration 3012395857) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012395857
- Address
- No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District, Shenzhen Guangdong, China, 518173
- Owner or operator
- Shenzhen Boon Medical Supply Co., Ltd (10051055)
- Roles
- Manufacturer
- First device listed
- January 28, 2016
- Registered through
- 2027
- Brand names listed
- 400101-1 line connection tube(1500mm), 400101-2 screw connection tube(1500mm), 400101-3 line connection tube with valve(1500mm), 400101-4 screw connection tube with valve(1500mm), 400101-5 line connection tube with valve(1800mm), 400101-6 screw connection tube with valve(1800mm), 400101-7 line connection tube with valve(200mm), 400101-8 line connection tube with valve and screw union(200mm) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2024 | K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | DXT | Substantially Equivalent | Shenzhen Boon Medical Supply Co., Ltd. | accessdata.fda.gov |
| October 19, 2021 | K211564 | Sterile High-pressure Angiographic Syringes for Single-use | DXT | Substantially Equivalent | Shenzhen Boon Medical Supply Co., Ltd. | accessdata.fda.gov |
| August 7, 2020 | K192657 | Sterile High-pressure Angiographic Syringes for Single-use | DXT | Substantially Equivalent | Shenzhen Boon Medical Supply Co., Ltd. | accessdata.fda.gov |
| October 10, 2018 | K182289 | Sterile High-pressure Angiographic Syringes for Single-use | DXT | Substantially Equivalent | Shenzhen Baoan Medical Supplies Co., Ltd. | accessdata.fda.gov |
| January 7, 2016 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use | DXT | Substantially Equivalent | Shenzhen Baoan Medical Supplies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.