BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    SGPT (ALT) REAGENT SET (COLORIMETRIC)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414553153·AST/GOT - ADVIA Chem. - Conc. RGT - 6x850 tests

    SYNCHRON URIC ACID

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code KNK·June 10, 2011

    VERIFY VH2O2 Indicator Tape

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Any-Etch

    FDA 510(k)
    FDA Class 2 ·Dental

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014

    SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FDI·October 7, 2010

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·December 5, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012