9 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Nussloch GmbH ASP6025 Tissue Processor
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·July 12, 2017
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·December 18, 2019
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·October 5, 2022
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·December 21, 2022
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·October 5, 2022
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·October 5, 2022
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·December 21, 2022
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·October 5, 2022
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·December 21, 2022