BEUDAMED
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    I-STAT CHEM 8+N CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD·Product code GKF·November 3, 2010

    I-STAT CHEM 8+ CARTRIDGE

    FDA Adverse Event
    Other ·ABBOTT POINT OF CARE CANADA LTD.·Product code GKF·July 10, 2009

    I-STAT EG7+ CARTRIDGE

    FDA Adverse Event
    Other ·ABBOTT POINT OF CARE CANADA LTD.·Product code GKF·March 5, 2009

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code GKF·September 19, 2017

    STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code GKF·June 19, 2017

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GKF·May 24, 2005

    Instrument, Hematocrit, Automated

    FDA classification
    FDA Class 2 ·Instrument, Hematocrit, Automated

    EKF Link

    FDA UDI
    EKF-diagnostic GmbH·04048534002011·EKF Link is a data and device management system...

    GBF INC

    FDA registration
    GBF INC·1 product·🇺🇸 United States

    EKF Life Sciences

    FDA registration
    EKF Life Sciences·3 products·🇺🇸 United States

    EKF DIAGNOSTIC GMBH

    FDA registration
    EKF DIAGNOSTIC GMBH·4 products·🇩🇪 Germany

    dental diamond bur

    FDA UDI
    STRAUSS & CO - INDUSTRIAL DIAMONDS LTD·D877G1F6·Wheel Diamond Bur Fine Grit(NSI)

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170714·Flat Handle Beaver Blade Handle - From Sample

    SUNCAST D-KF

    FDA 510(k)
    FDA Class 2 ·Dental

    GKB VISION PRIVATE LIMITED

    FDA registration
    GKB VISION PRIVATE LIMITED·2 products·🇮🇳 India

    GKB EYECARE PVT LTD

    FDA registration
    GKB EYECARE PVT LTD·1 product·🇮🇳 India

    GKB HI-TECH MIDDLE EAST

    FDA registration
    GKB HI-TECH MIDDLE EAST·1 product·🇦🇪 United Arab Emirates

    GKB OPHTHALMICS LIMITED - UNIT II

    FDA registration
    GKB OPHTHALMICS LIMITED - UNIT II·1 product·🇮🇳 India

    EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

    FDA 510(k)
    FDA Class 2 ·Hematology