BEUDAMED
    22 results · 32ms · Sources: EU EUDAMED, US FDA

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    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·November 26, 2014

    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Recall
    Terminated ·Nidek Inc·Product code LZS·August 6, 2012

    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

    FDA Recall
    Terminated ·Cynosure, Inc.·Product code GEX·October 9, 2014

    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·October 24, 2012

    MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·March 27, 2012

    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

    FDA Recall
    Terminated ·Biolase Technology Inc·Product code GEX·June 12, 2014

    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·May 24, 2013

    AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

    FDA Recall
    Terminated ·VISX INCORPORATED, A SUBSIDIARY OF AMO INC·Product code LZS·December 13, 2007

    LADARVision Excimer Laser System.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc.·Product code LZS·August 1, 2005

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code GEX·August 19, 2013

    Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUJ·August 19, 2020

    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·June 15, 2015

    WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.

    FDA Recall
    Terminated ·Wavelight AG Industriegebiet Doellnitz 5 Pressath Germany·Product code HNO·April 18, 2011

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014

    GE Discovery MR950 MRI system

    FDA Recall
    Terminated ·GE Healthcare·Product code IWE·October 24, 2014

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Recall
    Terminated ·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GEX·March 25, 2015

    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NFG·March 1, 2016

    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EKS·December 12, 2012