Data / Medical devices / Endoscopic Injection Needle, Gastroenterology-Urology / China
FDA-registered makers of Endoscopic Injection Needle, Gastroenterology-Urology in China: 15 establishments
15 establishments in China are registered with the FDA to make Endoscopic Injection Needle, Gastroenterology-Urology (product code FBK). 14 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Endoscopic Injection Needle, Gastroenterology-Urology
- Product code
- FBK
- Country
- China
Makers of Endoscopic Injection Needle, Gastroenterology-Urology in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 2 | May 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 2 | May 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Manufacturer | 1 | September 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Anrei Medical (Hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | May 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Manufacturer | 1 | June 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Newmed Micro-Medtech Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 1 | December 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer, Repackager or relabeler | 1 | February 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Promisemed Hangzhou Meditech Co.,ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wilson Instruments (sha) Co., Ltd. | Shanghai, China | Manufacturer | 1 | January 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 1 | August 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | February 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Soudon Medical Technology Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | November 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | CHANGZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.