BEUDAMED
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    SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA, INC.·Product code LNM·October 17, 2013

    INTRODEUCE DOUBLE LUMEN INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA, INC.·Product code LNM·October 17, 2013

    V40 COCR LFIT HEAD 36MM/0

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 3, 2013

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 28, 2011

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 18, 2008

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·April 21, 2026

    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

    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

    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