BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    OMNIPATCH

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    STERLTECH WATER PURIFIER

    FDA 510(k)
    FDA Class 1 ·Dental

    ADHESE ONE F

    FDA 510(k)
    FDA Class 2 ·Dental

    OEC

    FDA UDI
    TIDI PRODUCTS, LLC·00618125112371·OEC UroView 2600, Disposable Wide Footswitch Co...

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 27, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 10, 2010

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014