BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    DOCUMENT ENZYME LINEARITY TEST SETS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981130367·Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop

    MICROSPAN SYSTEM

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code FED·June 8, 2006

    CERTIFIED BLOOD BANK SALINE

    FDA 510(k)
    FDA Class 1 ·Pathology

    Penumbra Aspiration System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 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