BEUDAMED
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    DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

    FDA 510(k)
    FDA Class 2 ·Immunology

    Venturi Gauze Wound Care Sets with Portal Drain

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AXIS-SHIELD ANTI-CCP

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTASE PHENYLALANINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CARIESCAN PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA Centaur Erythropoietin (EPO) assay

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARCHITECT Active-B12 (Holotranscobalamin)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

    FDA 510(k)
    FDA Class 2 ·Immunology

    Filler, Bone Void, Synthetic Peptide

    FDA Pre-Market Approval
    FDA Class 3 ·PearlMatrix™ Bone Graft

    STA® - Liatest® D-Di PLUS

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR

    Automatic Hematology Analyzer DD-5 Fluorescent Dye A

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Maccura Biotechnology Co., Ltd. ·1 device