|
Device |
catheter, retention type, balloon |
Product Code | EZL |
Regulation Number |
876.5130
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMSINO INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
APOLLON CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSORS INTERNATIONAL PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C. R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK UROLOGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVALON TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGANIA SILICONE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EMMY MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLUME CATHETER COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU PRIMECARE MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HR PHARMACEUTICALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NELLIE MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PATHWAY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PERCUVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERCUVISION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POIESIS MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POTRERO MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
SAFE MEDICAL DESIGN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEEDINGS LIFE SCIENCE VENTURES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SENTINEL MEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILQ TECHNOLOGIES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SILQ TECHNOLOGIES, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
THE FLUME CATHETER COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
URETHROTECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WELL LEAD MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|