Koelis

Medical device manufacturer in Meylan, FR.

7510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K180970Disposable guides KDNG00ITX · Traditional 07/10/2018SE
K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…ITX · Traditional 07/31/2017SE
K170521TRINITY/3D Prostate SuiteIYN · Traditional 05/30/2017SE
K160357TrinityIYN · Traditional 05/02/2016SE
K141334Reusable GuideITX · Traditional 07/11/2014SE
K1314483D Prostate Suite 3DTRUS Prostate Mapping, MRI/3DTRUS Fusion Option, Second Look 3DTRUS…LLZ · Traditional 07/26/2013SE
K100793Urostation 3D Prostate SuiteLLZ · Traditional 09/22/2010SE