|
Device |
syringe, piston |
Product Code | FMF |
Regulation Number |
880.5860
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCURO TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEA SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AZUR MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
B. BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BECTON, DICKINSON, AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERPU MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERPU MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BONE SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONUS THERAPEUTICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIRANA T. INJECTA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTROL MEDICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DLP MEDICAL PRODUCTS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLAT MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLAT MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG ANTMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANTECH MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HWAJIN MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTYLLA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTERNATIONAL MEDICAL INDUSTRIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU JICHUN MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU KANGYOU MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU SUYUN MEDICAL MATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI MAIDIKANG MEDICAL DEVICES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFELONG MEDITECH PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFENET HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MD3 LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDONE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDWELL TECHNOLOGY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MILESTONE SCIENTIFIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANUM COMPANY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIPRO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NOVO NORDISK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OCUJECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORBIT BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORBIT BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROMISEMED HANGZHOU MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANDONG QINKAI MEDICAL INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINA MED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOL-MILLENNIUM MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SURGENTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOP CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|