BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    ENDOSCOPY VIDEO CAMERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FAST THERMOMETER MODELS ST713C AND ST713F

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·April 29, 2013

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·July 24, 2008

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

    UNFOLDER PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·September 19, 2013

    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 20, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012