BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    KIMBA MINI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Regent

    FDA UDI
    SPINAL ELEMENTS·00840916114930·Regent ACP 3-Level, 49mm

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605951·STERIS CMAX 2.25" DELUXE GEL

    MOTORIZED MICRO MULTILEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    DUAL LUMEN MIDLINE CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·March 25, 2015

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 26, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

    HARMONIC SCALPEL GENERATOR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 2008

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 27, 2014

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 24, 2014

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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