Ez-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-Io

• • Terminated Z-1829-2017 FDA Class III ·initiated 29 Mar 2017

  Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

510(k) Number

K091140 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ez-Io Intraosseous Infusion System Open recall

  Class II

  FDA 510(k) K141117 Active Cleared 8 Jul 2014

• Ez-Connect

  Class II

  FDA 510(k) K061771 Active Cleared 10 Jul 2006

• The OnControl Bone Marrow Biopsy System by Vidacare

  Class II

  FDA 510(k) K142377 Active Cleared 17 Dec 2014

• The T.A.L.O.N. Intraossous Infusion System by Vidacre

  Class II

  FDA 510(k) K120661 Active Cleared 3 Jun 2012

• Powered Pd-Io Intraosseous Infusion System

  Class II

  FDA 510(k) K051992 Active Cleared 20 Oct 2005

• Vidaport Intraosseous Infusion System

  Class II

  FDA 510(k) K032885 Active Cleared 10 Mar 2004

See all devices from Vidacare Corporation →