|
Device |
blood establishment computer software and accessories |
Product Code | MMH |
Regulation Number |
864.9165
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
|
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLIANCE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARC-ONE SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-RAD MEDICAL DIAGNOSTICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLIFE PLASMA SERVICES L.P. - BAXALTA US INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMAT USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIQ-HEALTH SOLUTIONS, LDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLOOD BANK COMPUTER SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BUOY SOFTWARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARTER BLOODCARE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CSL PLASMA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DATA INNOVATIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPARTMENT OF VETERANS AFFAIRS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIAGNOSTIC GRIFOLS, S. A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDONORSOFT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIC SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GPI USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRIFOLS DIAGNOSTIC SOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HAEMONETICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEADSPRING HEALTHCARE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHCARE-ID, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HEMASOFT SOFTWARE SL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMMUCOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KEDRION S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE PLASMA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFESOUTH COMMUNITY BLOOD CENTERS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAK-SYSTEM GROUP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAK-SYSTEM SA INTERNATIONAL GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL INFORMATION TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIWARE INFORMATION SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCC SOFT COMPUTER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRATEC BIOMEDICAL UK LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNQUEST INFORMATION SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SYSLOGIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO BCT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WELLSKY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
ConvaTec, Inc |
II |
May-16-2018 |
|
|
|
|