BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    ELVI MAGNESIUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Infinity Angioplasty Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTI-MUTATED CITRULLINATED VIMENTIN EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2014

    12/14 ARTICUL 40MM M SPEC-2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 16, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 20, 2015

    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 11, 2014