Vidacare Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1801-2015Class IIT.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EMay 12, 2015
Z-2672-2014Class IIEZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455March 31, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K132583EZ-IO INTRAOSSEOUS INFUSION SYSTEMFebruary 11, 2014
K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREJune 3, 2012
K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREMarch 8, 2012
K101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IOJuly 27, 2010
K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IOOctober 14, 2009
K081713VERTEBRAL ACCESS SYSTEM BY VIDACARENovember 21, 2008
K072045ONCONTROL BONE MARROW BIOPSY SYSTEMOctober 22, 2007
K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEMMay 21, 2007
K063567EZ-MIO STERNALJanuary 26, 2007
K063142MANUAL PD-IO; POWERED PD-IODecember 8, 2006
K062956EZ-MIO, EZ-IO DISTAL TIBIADecember 5, 2006
K062833POWERED EZ-IO BONE MARROW ASPIRATION SYSTEMNovember 30, 2006
K062422HUMERAL HEAD, MANUAL DRIVERNovember 7, 2006
K061771EZ-CONNECTJuly 10, 2006
K052408EZ-IONovember 17, 2005
K052195EZ-MIO MANUAL DRIVERNovember 2, 2005
K051992POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEMOctober 20, 2005
K043490PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEFebruary 18, 2005
K032885VIDAPORT INTRAOSSEOUS INFUSION SYSTEMMarch 10, 2004