Imalux Corporation

Medical device manufacturer in Cleveland, OH.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K042894Imalux Niris Imaging SystemNQQ · Special 11/19/2004SE
K041077Imalux Oct Probe GuideKKX · Traditional 06/25/2004SE

Recalls

RecallProductInitiated
Z-0934-2012 Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX…During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the… 12/22/2011Terminated