Leica Microsystems (Schweiz) AG

Medical device manufacturer in Heerbrugg, CH.

3510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K181537GLOW800IZI · Traditional 09/07/2018SE
K170239Leica FL560IZI · Traditional 07/05/2017SEKD
K080612Leica FL800IZI · Traditional 05/09/2008SE

Recalls

RecallProductInitiated
Z-2177-2013 Class IISurgical microscope The device is used to improve the visibility of objects through…The brake in the Z axis and/or brakes in the AB and C axes failed during installation. 12/18/2012Terminated
Z-2176-2013 Class IISurgical microscope The device is used to improve the visibility of objects through…The brake in the Z axis and/or brakes in the AB and C axes failed during installation. 12/18/2012Terminated