|
Device |
insufflator, laparoscopic |
Product Code | HIF |
Regulation Number |
884.1730
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BUFFALO FILTER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIA INNOVATION AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORE ACCESS SURGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FREYJA HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRI MEDICAL AND ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GYNETECH PTY. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIPPOKRATEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LEXION MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LEXION MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDLINE, INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORTHGATE TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PALLIARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PREMIUM MEDICAL TECHNOLOGY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOPRO - ACTEON GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGIQUEST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAUTONA GROUP RESEARCH & DEVELOPMENT, CO. LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMAX MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.O.M WORLD OF MEDICINE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
W.O.M. WORLD OF MEDICINE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|