BEUDAMED
    56 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 14, 2015

    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

    FDA Enforcement
    Class II ·Terminated·Insight Instruments, Inc.·May 22, 2013

    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

    FDA Enforcement
    Class II ·Terminated·Invuity, Inc.·October 10, 2012

    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.

    FDA Enforcement
    Class II ·Terminated·Nico Corp.·June 16, 2021

    Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.

    FDA Enforcement
    Class II ·Terminated·Nico Corp.·June 16, 2021

    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·August 1, 2012

    The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·April 5, 2017

    Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·February 11, 2026

    Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·January 7, 2026

    Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument 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 Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·January 30, 2019

    Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·February 11, 2026

    Helion and Xenion surgical lights, 501/01 series KLM lights. The 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.·October 24, 2012

    Leica Surgical Operating Microscopes, Arveo, Part Number 10448999

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·October 5, 2022

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    FDA Enforcement
    Class II ·Terminated·Maquet Medical Systems USA·June 18, 2014

    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·October 5, 2022

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·May 30, 2018

    Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·October 5, 2022

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013

    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·April 27, 2016

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024