BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    CONTINUOUS FLUSH DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    AEROSOL & OXYGEN MASKS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 8, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 11, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 10, 2010

    Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CIQ·July 20, 2016

    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CGX·July 20, 2016

    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CKA·July 20, 2016

    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CGA·July 20, 2016

    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CHH·July 20, 2016

    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CDL·July 20, 2016

    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code LFQ·July 20, 2016

    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code LBR·July 20, 2016

    Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code JIY·July 20, 2016