Combat Medical Systems, LLC

Medical device manufacturer in Harrisburg, NC.

3510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K141685CrocDXC · Traditional 01/26/2015SE
K130482Combat Ready ClampDXC · Traditional 04/29/2013SE
K102025Combat Ready ClampDXC · Traditional 08/11/2010SE

Recalls

RecallProductInitiated
Z-1114-2021 Class IFresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit.…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. 12/23/2020Terminated
Z-1113-2021 Class IFresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. 12/23/2020Terminated
Z-1112-2021 Class ILow Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. 12/23/2020Terminated
Z-1111-2021 Class IValkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. 12/23/2020Terminated
Z-1110-2021 Class IValkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. 12/23/2020Terminated