BEUDAMED
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    LANG DENTAL ACRYLIC PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    MHS 5000

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

    FDA 510(k)
    FDA Class 2 ·Immunology

    WEREWOLF FLOW 90 COBLATION WAND

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·May 19, 2022

    BLUNT TIP SCREW, 4X48MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·February 21, 2023

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·April 29, 2013

    VERSA-FX LINKED LAG SCREW INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·April 5, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·July 22, 2008

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 5, 2023

    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