BEUDAMED
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    PTA BALLOON DILATATION CATHETERS

    Device
    EU MDD · Eu Md Class 2a ·BrosMed Medical Co., Ltd·On the market·1 country

    Newmedi

    Device
    EU MDR · Eu Md Class 1 ·NEWMEDI·On the market

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·ISOMED IMPLANTABLE INFUSION PUMP

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM

    GRU Femur

    FDA UDI
    GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED·09340499005430·GRU Femur RLLM Size 0

    GRU Femur

    FDA UDI
    GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED·09340499005492·GRU Femur RMLL Size 0

    GRU Femur

    FDA UDI
    GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED·09340499005508·GRU Femur RMLL Size 1

    GRU Femur

    FDA UDI
    GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED·09340499005447·GRU Femur RLLM Size 1

    BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    Dimension Vista MMB Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GentleCath Intermittent Urinary Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TGL FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

    FDA 510(k)
    FDA Class 2 ·Immunology