Company ยท US
Vidacare Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2014. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2014 | K142377 | The OnControl Bone Marrow Biopsy System by Vidacare Vidacare, LLC | KNW |
| Jul 8, 2014 | K141117 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare, LLC | FMI |
| Feb 11, 2014 | K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
| Jun 3, 2012 | K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE Vidacare Corporation | FMI |
| Mar 8, 2012 | K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE Vidacare Corporation | KNW |
| Jul 27, 2010 | K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO Vidacare Corporation | FMI |
| Oct 14, 2009 | K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO Vidacare Corporation | FMI |
| Nov 21, 2008 | K081713 | VERTEBRAL ACCESS SYSTEM BY VIDACARE Vidacare Corporation | MOQ |
| Oct 22, 2007 | K072045 | ONCONTROL BONE MARROW BIOPSY SYSTEM Vidacare Corporation | KNW |
| May 21, 2007 | K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM Vidacare Corporation | FCF |
| Jan 26, 2007 | K063567 | EZ-MIO STERNAL Vidacare Corporation | FMI |
| Dec 8, 2006 | K063142 | MANUAL PD-IO; POWERED PD-IO Vidacare Corporation | FMI |
| Dec 5, 2006 | K062956 | EZ-MIO, EZ-IO DISTAL TIBIA Vidacare Corporation | FMI |
| Nov 30, 2006 | K062833 | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM Vidacare Corporation | FCF |
| Nov 7, 2006 | K062422 | HUMERAL HEAD, MANUAL DRIVER Vidacare Corporation | FMI |
| Jul 10, 2006 | K061771 | EZ-CONNECT Vidacare Corporation | FPA |
| Nov 17, 2005 | K052408 | EZ-IO Vidacare Corporation | FMI |
| Nov 2, 2005 | K052195 | EZ-MIO MANUAL DRIVER Vidacare Corporation | FMI |
| Oct 20, 2005 | K051992 | POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
| Feb 18, 2005 | K043490 | PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Vidacare Corporation | FMI |
| Mar 10, 2004 | K032885 | VIDAPORT INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2015 | Vidacare Corporation T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation Terminated |
FMI | K120661 |
| Sep 22, 2014 | Vidacare Corporation EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 Terminated |
FMI | K052408 |