BEUDAMED
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    STIWELL MED4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    miniARM® multiSTATION™ System

    FDA UDI
    LSI Solutions, Inc.·00850012846147·M55™ RIGID miniARM® HOLDER

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608518·BERCHTOLD 3.25" SOFTCARE PLUS

    GentleYAG

    FDA UDI
    Candela Corporation·00817495022628·Pulsed Laser

    EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

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

    CYPRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFORATOR DRIVER W/HUDSON END

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·April 24, 2013

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2011

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·July 23, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014