|
Device |
needle, conduction, anesthetic (w/wo introducer) |
Product Code | BSP |
Regulation Number |
868.5150
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AERIN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANCORA MEDICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B. BRAUN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
B.BRAUN MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKSON & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DISCCATH LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DR. JAPAN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENTELLUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL MEDIKIT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAURIMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LCCS PRODUCTS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE-TECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE, INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYCO MEDICAL SUPPLIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAJUNK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAJUNK GMBH MEDIZINTECHNOLOGIE |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMINGTON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SOLO-DEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRA MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRA MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMMIT MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULTRASONIX MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNISIS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|