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

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    X-LEONARDO

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARTO XP SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    COLLATEK SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    COLLATEK HYDROGEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 9, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    VITALITY DS VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023

    NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021