BEUDAMED
    26 results · 24ms · Sources: EU EUDAMED, US FDA

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    Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OCT-Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Spectralis HRA+OCT and variants with OCT Angiography Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OCT-Camera ID 21101A3

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Pentacam® Cornea OCT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Spectralis HRA + OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRALIS HRA+OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    neon3™ universal OCT spinal stabilization

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spectralis HRA+OCT and Variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRALIS HRA+OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRALIS HRA+OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Spectralis HRA+OCT and variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Spectralis HRA+OCT and variants with High Magnification Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·October 24, 2018

    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:

    FDA Enforcement
    Class II ·Ongoing·Contract Medical International GmbH·September 17, 2025

    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·February 11, 2015