GMBClass I
Light, Wood's, Fluorescence
Microbiology · 21 CFR 866.2600
MDR events5All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances0All time
Recent MDR events
5 adverse event reports on file
- BARDEX® ALL-SILICONE FOLEY CATHETERJun 24, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-04983
- MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7FApr 18, 2021MalfunctionCordis Santa Clara3004939290-2021-02120
- SPEEDICATH SOFTApr 9, 2021InjuryColoplast A/s3006606901-2021-00011
- MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7FOct 19, 2020MalfunctionCordis Santa Clara3004939290-2020-01926
- MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7FApr 29, 2020MalfunctionCordis Santa Clara3004939290-2020-01743
Event type breakdown
Malfunction4
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
Xuzhou Kernel Medical Equipment Co Ltd
Xuzhou Jiangsu, CN
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Ziree (shenzhen) Medical Technology Co.,ltd
Shenzhen Guangdong, CN
Wuhan Zjzk Technology Co.,ltd. (aka Wuhan Zjkc Technology Co.,ltd.)
Wuhan Hubei, CN
Advance-esthetic Llc
Fort Lauderdale, FL, US
Medical Illumination International, Inc
Chatsworth, CA, US
Hue Light Co., Ltd
Gwangmyeong-si Gyeonggi, KR
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.