|
Device |
tubes, vials, systems, serum separators, blood collection |
Product Code | JKA |
Regulation Number |
862.1675
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AVIA VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON, DICKINSON & COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON, AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIRANA T. INJECTA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECLIPSE MEDCORP LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GREINER BIO-ONE NA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAWASUMI LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KURIN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KURIN, INC, |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAGNOLIA MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAGNOLIA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NSP TECH PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OWEN MUMFORD LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RETRACTABLE TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SB-KAWASUMI LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SOL-MILLENNIUM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VELANO VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VELANO VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU MEDLINE INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2018 |
9731 |
9731 |
2019 |
6469 |
6469 |
2020 |
3774 |
3774 |
2021 |
3610 |
3610 |
2022 |
3375 |
3375 |
2023 |
2911 |
2911 |
|
|
|
|