BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    RENCTK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACUMED

    FDA UDI
    Acumed LLC·10806378044649·3.0mm T-Handle Reamer

    CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUSA Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    APC PLUS ADHESIVE

    FDA Adverse Event
    Injury ·3M UNITEK·Product code DYW·June 7, 2007

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 8, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2012

    UNKNOWN DEPUY 28X48 10D LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010

    TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXH·October 21, 2010

    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014