BEUDAMED
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    SKIL-CARE LEG PADS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HEARTLINE POTTS VASCULAR SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896095113·HEARTLINE POTTS VASCULAR SCISSORS ANGLED BLADE ...

    Mini Tweed

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746113697·DB BKT MINI TWEED LOWER ANT 018 T=0 A=0 R=0

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036052751·

    ACUMED

    FDA UDI
    Acumed LLC·10806378040481·Acutrak® Std<20mm Trephine

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197491204·Kelly Retractor 25x38m...

    Spetzler, Claw

    FDA UDI
    STRYKER CORPORATION·07613252026556·Spetzler/Micro Claw Tip

    Agape Warming Personal Lubricant

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

    IMC SURGICAL DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DISPOSABLE PURSTRING 65 INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·April 28, 2014

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·February 23, 2010

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 11, 2011

    Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·October 14, 2010

    Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·August 23, 2010

    VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·October 21, 2013

    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·August 13, 2012