BEUDAMED
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    Meridiem

    FDA UDI
    Z MICROSYSTEMS, INC.·00869958000131·Meridiem Surgical Video System

    Clarity

    FDA UDI
    Z MICROSYSTEMS, INC.·00869958000117·The Clarity System delivers significant capabil...

    GRANITE MICROSYSTEMS, INC.

    FDA registration
    GRANITE MICROSYSTEMS, INC.·1 product·🇺🇸 United States

    Leica Microsystems NC, Inc.

    FDA registration
    Leica Microsystems NC, Inc.·2 products·🇺🇸 United States

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    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC.·Product code EPT·December 31, 2003

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Injury ·LEICA MICROSYSTEMS, INC.·Product code IEO·May 2, 2013

    MICROSCOPE

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC.·Product code EPT·March 13, 2007

    *

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC.·Product code EPT·September 21, 2011

    LEICA MICROSYSTEMS

    FDA Adverse Event
    Other ·LEICA MICROSYSTEMS, INC.·Product code IEO·October 11, 2006

    LEICA OH 5 IC GREEN

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC.·Product code EPT·November 24, 2012

    SUN MICROSYSTEMS/SHELL UNIX

    FDA Adverse Event
    Injury ·SUN MICROSYSTEMS, INC.·Product code MCM·June 20, 2004

    PELORIS

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC.·Product code IEO·July 27, 2016

    PELORIS II

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS INC·Product code IEO·July 27, 2016

    LEICA OH5

    FDA Adverse Event
    Injury ·LEICA MICROSYSTEMS INC.·Product code EPT·August 1, 2013

    *

    FDA Adverse Event
    Malfunction ·LEICA MICROSYSTEMS, INC·Product code FSO·January 15, 2015

    LEICA RM 2155 AUTOMATED MICROTOME

    FDA Adverse Event
    Injury ·LEICA MICROSYSTEMS, INC.·Product code IEO·April 5, 2001

    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code ETP·December 21, 2011

    Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code EPT·April 12, 2005

    Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The Bond Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probes on Bond-max and Bond-x instruments, using the aspirating probe cleaning protocol installed in Bond systems. Product Quantity Distributed (Int) 1 kit

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·July 26, 2011

    Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·July 26, 2011