| 2026-06-12 |
K252987 |
ADRx Admixture Device |
LHI |
Class II |
General Hospital |
| 2026-04-24 |
K250234 |
SMARTeZ Elastomeric Infusion Pump (RS series) |
MEB |
Class II |
General Hospital |
| 2025-12-05 |
K251722 |
ProSeal Transfer Injector (421120, 421130, 421140) |
ONB |
— |
— |
| 2025-08-29 |
K251814 |
EZ IV Administration Set |
FPA |
— |
— |
| 2025-08-01 |
K252094 |
eZSURE Empty Fluid Container |
KPE |
Class II |
General Hospital |
| 2025-05-29 |
K251340 |
ProSeal Bag Spike with Additive Port (423370ST, 423370) |
ONB |
— |
— |
| 2025-01-22 |
K243976 |
ZeroClear Bag Access (423100) |
ONB |
— |
— |
| 2024-12-26 |
K240517 |
ProSeal Vented Universal Vial Adaptor |
ONB |
— |
— |
| 2024-10-23 |
K241988 |
ProSeal Closed System Bag Access |
ONB |
— |
— |
| 2024-10-10 |
K241735 |
ProSeal In Line Pump Set (423850) |
ONB |
— |
— |
| 2024-10-07 |
K242152 |
SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) |
MEB |
Class II |
General Hospital |
| 2024-08-30 |
K241823 |
ToxiSeal Vial Adaptor |
ONB |
— |
— |
| 2024-06-21 |
K241476 |
ToxiSeal Vial Adaptor with External Flip Balloon |
ONB |
— |
— |
| 2024-06-21 |
K241442 |
eZSURE Empty Fluid Container with ProSeal Injection Site |
KPE |
Class II |
General Hospital |
| 2024-05-21 |
K240433 |
ProSeal Injection Site Extended Male Luer Lock (422140) |
ONB |
— |
— |
| 2024-03-28 |
K240171 |
ProSeal Injector Plus (Model no. 421050) |
ONB |
— |
— |
| 2024-01-11 |
K222929 |
ToxiSeal Vial Adapter with External Balloon |
ONB |
— |
— |
| 2023-11-03 |
K230343 |
ProSeal Closed System Administration Set |
FPA |
— |
— |
| 2023-09-01 |
K223674 |
eZSURE Empty Fluid Container (models 426030, 426040, 426110) |
KPE |
Class II |
General Hospital |
| 2021-03-24 |
K201626 |
Safety Subcutaneous Infusion Set |
FPA |
— |
— |
| 2020-08-07 |
K192075 |
ProSeal Closed System drug Transfer Device (CSTD) |
ONB |
— |
— |