BEUDAMED
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    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW

    EYE ARTIFICIAL CUSTOM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ARTIFICIAL SCLERAL SHELL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    EDEC 60 R/F

    FDA 510(k)
    FDA Class 1 ·Radiology

    EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    COMPACT-X

    FDA 510(k)
    FDA Class 1 ·Radiology

    VIEW NT

    FDA 510(k)
    FDA Class 2 ·Radiology

    EDEC 2000

    FDA 510(k)
    FDA Class 1 ·Radiology

    VIEW COM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EDEC 90C

    FDA 510(k)
    FDA Class 1 ·Radiology

    CD-R STATION AND VRS-2000

    FDA 510(k)
    FDA Class 1 ·Radiology

    VIEW ARCHIVING STATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEXA™ NPWT System

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

    NEXA Negative Pressure Wound Therapy System

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

    EDEC 60R

    FDA 510(k)
    FDA Class 1 ·Radiology

    VIEW READING STATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    AB5000

    FDA UDI
    Abiomed, Inc.·00813502010701·Ventricular (Assist) Bypass

    AB5000

    FDA UDI
    Abiomed, Inc.·00813502010732·Ventricular (Assist) Bypass