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    EXAMION GmbH

    Manufacturer
    🇩🇪 Germany

    EXAMION GmbH

    Importer
    🇩🇪 Germany

    EXAMION GmbH

    System producer
    🇩🇪 Germany

    Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·September 12, 2012

    Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IDP·September 23, 2010

    Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IDP·September 23, 2010

    Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FSY·May 29, 2012

    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 18, 2015

    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 18, 2015

    ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·March 30, 2012

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.

    FDA Recall
    Terminated ·Stryker Leibinger USA·Product code JEY·September 19, 2008

    Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code KPR·January 21, 2009