|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
stockert s5 system
|
LivaNova Deutschland GmbH
|
K210130 |
04/05/2021
|
essenz hlm, essenz ilbm
|
LivaNova Deutschland GmbH
|
K232291 |
08/24/2023
|
essenz hlm
|
LivaNova Deutschland GmbH
|
K221373 |
03/09/2023
|
cardiohelp system
|
MAQUET CARDIOPULMONARY AG
|
K133598 |
05/21/2014
|
cardiohelp system
|
MAQUET CARDIOPULMONARY AG
|
K102726 |
04/04/2011
|
s3 cardioplegia control module version 2.0
|
MEDICAL DEVICE CONSULTANTS, INC.
|
K002116 |
08/09/2000
|
medtronic performer tm cpb, model r51, pcpb
|
RAND S.R.L.
|
K052555 |
03/15/2006
|
performer cbp system
|
RAND S.R.L.
|
K070213 |
03/21/2007
|
stockert-shiley caps battery module
|
SHILEY, INC.
|
K863960 |
12/11/1986
|
stockert-shiley caps timer module
|
SHILEY, INC.
|
K862973 |
10/01/1986
|