Vidacare Corporation

Medical device manufacturer in Shavano Park, TX.

21510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K142377The OnControl Bone Marrow Biopsy System by VidacareKNW · Traditional 12/17/2014SE
K141117Ez-Io Intraosseous Infusion SystemFMI · Traditional 07/08/2014SE
K132583Ez-Io Intraosseous Infusion SystemFMI · Traditional 02/11/2014SE
K120661The T.A.L.O.N. Intraossous Infusion System by VidacreFMI · Traditional 06/03/2012SE
K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareKNW · Traditional 03/08/2012SE
K101026Powered Pd-Io Infusion System, Ez-Io Humeral Head, Powered Ph-IoFMI · Traditional 07/27/2010SE
K091140Ez-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-IoFMI · Traditional 10/14/2009SE
K081713Vertebral Access System by VidacareMOQ · Traditional 11/21/2008SE
K072045Oncontrol Bone Marrow Biopsy SystemKNW · Traditional 10/22/2007SE
K070759Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional 05/21/2007SE
K063567Ez-Mio SternalFMI · Traditional 01/26/2007SE
K063142Manual Pd-Io; Powered Pd-IoFMI · Traditional 12/08/2006SE
K062956Ez-Mio, Ez-Io Distal TibiaFMI · Traditional 12/05/2006SE
K062833Powered Ez-Io Bone Marrow Aspiration SystemFCF · Traditional 11/30/2006SE
K062422Humeral Head, Manual DriverFMI · Traditional 11/07/2006SE
K061771Ez-ConnectFPA · Traditional 07/10/2006SE
K052408Ez-IoFMI · Traditional 11/17/2005SE
K052195Ez-Mio Manual DriverFMI · Traditional 11/02/2005SE
K051992Powered Pd-Io Intraosseous Infusion SystemFMI · Traditional 10/20/2005SE
K043490Pd-Io Disposable Intraosseous Infusion NeedleFMI · Traditional 02/18/2005SE
K032885Vidaport Intraosseous Infusion SystemFMI · Traditional 03/10/2004SE

Recalls

RecallProductInitiated
Z-1801-2015 Class IIT.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE…Potential breach in sterility 05/12/2015Terminated
Z-2672-2014 Class IIEZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455The voluntary recall is due to the needle set not meeting its specifications. 03/31/2014Terminated