Leica Microsystems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
40
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0477-2023Class IILeica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope systemNovember 21, 2022
Z-0475-2023Class IILeica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemNovember 21, 2022
Z-0476-2023Class IILeica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microsNovember 21, 2022
Z-1851-2022Class IILeica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950August 26, 2022
Z-1850-2022Class IILeica Surgical Operating Microscopes, M530 OHX, Part Number 10448737August 26, 2022
Z-1848-2022Class IILeica Surgical Operating Microscopes, ARveo 8, Part Number 10449063August 26, 2022
Z-1849-2022Class IILeica Surgical Operating Microscopes, Arveo, Part Number 10448999August 26, 2022
Z-0412-2022Class IILeica Microsystems M220 F12 Microscope SystemsNovember 3, 2021
Z-2481-2021Class IIBOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375July 30, 2021
Z-2399-2020Class IILeica ARveo and M530 OH6 microscope systems.May 20, 2020
Z-0673-2020Class IIBOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnoNovember 18, 2019
Z-1729-2019Class IILeica Cryostats, used to produce frozen sample sections for biological, medical and industrial appliMay 3, 2019
Z-0772-2019Class IILeica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrumeJanuary 2, 2019
Z-0281-2019Class IIBOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX September 17, 2018
Z-0019-2019Class IILeica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue September 4, 2018
Z-3175-2018Class IILeica M525 F20 Surgical Microscope SystemSeptember 4, 2018
Z-2659-2018Class IILeica M530 OHX Microscope System Supplied with 100 - 120 Vac.June 25, 2018
Z-0064-2019Class IILeica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use June 13, 2018
Z-2555-2018Class IILeica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article NumJune 4, 2018
Z-0838-2019Class IIPROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects thSeptember 25, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K061871LEICA MODEL FL800September 20, 2006
K990869LEICA AT550June 7, 1999