|
Device |
catheter, straight |
Product Code | EZD |
Regulation Number |
876.5130
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADAPTA MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AMSINO INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMSINO INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTRA TECH AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTRA TECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIG BLUE BIOTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONREE MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
COLOPLAST CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST MANUFACTURING US, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMPACTCATH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMPACTCATH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMPACTCATH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVATEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVATEC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
CURE MEDICAL LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DYNAREX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLEXICARE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOOTPRINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU JIMUSHI MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLLISTER INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROCHESTER MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHAOXING FUQING HEALTH PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WELLSPECT HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHANJIANG STAR ENTERPRISE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|