Leica Microsystems (Schweiz) Ag

FDA Regulatory Profile

Leica Microsystems (Schweiz) Ag appears in FDA public data with 2 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2177-2013, Class II) was initiated on Dec 18, 2012. Its most recent 510(k) clearance was granted on Mar 28, 2019.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2177-2013Class IISurgical microscope The device is used to improve the visibility of objects through magnificationDec 18, 2012
Z-2176-2013Class IISurgical microscope The device is used to improve the visibility of objects through magnificationDec 18, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
DEN180024Leica FL400Mar 28, 2019
K181537GLOW800Sep 7, 2018
K170239Leica FL560Jul 5, 2017
K080612LEICA FL800May 9, 2008