Oridion Systems Ltd. Can Resume Importing Most of its Medical Devices into the U.S.
Published: Jan 24, 2012
The FDA lifts most of its ban on the Israeli medical device company, clearing the way for Oridion Systems Ltd. to resume importing the bulk of its products into the U.S. Oridion Systems Ltd. (PINK:ORDNF) can resume importing medical devices into the U.S., after the FDA reduced its ban on the company to include just 2 of its product lines. On Dec. 20, 2011, the Israeli med-tech maker was barred by the FDA from importing any medical devices into the U.S, after the agency said the company failed to fix violations at its Jerusalem manufacturing facility. Earlier this week, the company was notified by the agency that it was narrowing the ban to include just the company's infant neonatal intubated CO2 sampling lines, specifically the Infant/Neonatal FilterLine H Set and Infant/Neonatal VitaLineTM H Set line.