BEUDAMED
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    PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    PROFEMUR MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·May 20, 2008

    7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    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

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014