FDA 510(k) Applications Submitted by Xi Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K221815 |
06/22/2022 |
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
Baisheng Medical Co., Ltd. |
| K183564 |
12/20/2018 |
Electrosurgical Generator |
Fulwell LLC |
| K151219 |
05/07/2015 |
Models 2200DR and 1600DR Digital Stationary Radiographic Systems |
BEIJING POLYCON MEDICAL ENGINEERING COMPANY |
| K203732 |
12/21/2020 |
Surgical Face Mask |
Zhuhai Gaoge Medical Technology Co., Ltd. |
| K191837 |
07/09/2019 |
UniSmile Clear Aligner System |
Vitang Technology, LLC |
| K173871 |
12/20/2017 |
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres |
Suzhou Hengrui Callisyn Biomedical Co., Ltd. |
| K213065 |
09/23/2021 |
Distal Access Catheter |
Guangzhou Easycess Medical Co., Ltd |
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