FDA 510(k) Applications Submitted by Xia Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212639 |
08/20/2021 |
Disposable Medical Nitrile Examination Gloves (Non sterile) |
Jiangsu Nanfang Medical Co., Ltd |
| K231660 |
06/07/2023 |
Digital image scanner of dental |
Jiangsu Dynamic Medical Technology Co., Ltd. |
| K151219 |
05/07/2015 |
Models 2200DR and 1600DR Digital Stationary Radiographic Systems |
BEIJING POLYCON MEDICAL ENGINEERING COMPANY |
| K240663 |
03/08/2024 |
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) |
Guangzhou Red Pine Medical Instrument Co.,Ltd. |
| K232003 |
07/06/2023 |
Endoscopic Video Image Processor, Single-Use Video Hysteroscope |
Guangzhou Red Pine Medical Instrument Co.,Ltd. |
| K203732 |
12/21/2020 |
Surgical Face Mask |
Zhuhai Gaoge Medical Technology Co., Ltd. |
| K240109 |
01/16/2024 |
Medical electronic thermometer (FC01, FC02) |
Zhuzhou Goldenhot Medical Technology Co.,Ltd. |
| K243085 |
09/30/2024 |
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) |
Zhuzhou Goldenhot Medical Technology Co.,Ltd. |
| K250185 |
01/22/2025 |
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) |
Jiangxi AICARE Medical Technology Co., Ltd. |
| K111857 |
06/30/2011 |
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE |
INMED GLOVES FACTORY |
| K240520 |
02/23/2024 |
Diode Laser Hair Removal System (SH-VD910) |
Beijing Sea Heart International Science And TechnologyCo.Ltd |
| K232587 |
08/25/2023 |
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
| K250606 |
02/28/2025 |
Dental Barrier and Sleeves |
Yueying Medical Instruments (Langfang) Co., Ltd. |
| K210679 |
03/08/2021 |
Medical Face Mask |
Wuxi Yushou Medical Appliances Co.,Ltd. |
| K202010 |
07/21/2020 |
Disposable Vinyl Glove |
Better Health Medical Products Co., Ltd. |
| K203666 |
12/16/2020 |
Vinyl Examination Gloves(Yellow) |
Lutai Medical Technology Co.,LTD. |
| K220211 |
01/26/2022 |
Nitrile Powder Free Examination Gloves |
Hebei kangxida Medical Technology Development Co., Ltd. |
| K221002 |
04/04/2022 |
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C |
Shenzhen Ulike Smart Electronics Co.,Ltd |
| K191802 |
07/03/2019 |
Electric Breast Pump |
Ningbo Huiyoo Baby Products Co. Ltd. |
| K202291 |
08/12/2020 |
Button Loop |
Yunyi (Beijing) Medical Device Co., Ltd. |
| K192637 |
09/24/2019 |
High Strength Suture |
Yunyi (Beijing) Medical Device Co., LTD |
| K192167 |
08/09/2019 |
CuraRad-ICH |
CuraCloud Corp. |
| K213657 |
11/19/2021 |
DEEPVESSEL FFR |
KeyaMed NA Inc. |
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