BEUDAMED
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    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN HCV TEST

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ TORIC INTRAOCULAR LENSES

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ RESTOR INTRAOCULAR LENSES

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKER DEVICES

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES

    DUALENZ LOW VISION EYEWEAR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BINOCULAR MAGNIFIER 2X

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MALIS SURGICAL LOUPES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BINOCULAR LOUPE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    EXETER OPERATING LOUPE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP

    Lipid Control S-Ⅱ

    FDA UDI
    DENKA COMPANY LIMITED·04987503563026·

    Lipid Control S-Ⅰ

    FDA UDI
    DENKA COMPANY LIMITED·04987503563019·

    small dense LDL Control Set

    FDA UDI
    DENKA COMPANY LIMITED·04987503563088·

    sLDL CONTROL - LEVEL 1 (sLDL CONTROL 1)

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273209075·

    sLDL CONTROL - LEVEL 3 (sLDL CONTROL 3)

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273209099·

    sLDL CONTROL - LEVEL 2 (sLDL CONTROL 2)

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273209082·