BEUDAMED
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    Attract Kft.

    Manufacturer
    🇭🇺 Hungary·10 Basic UDI-DIs·15 Devices·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.

    Laser Light Orvostechnikai Innovációs Kft.

    Manufacturer
    🇭🇺 Hungary·3 Basic UDI-DIs·3 Devices·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·HEMOBLAST™ Bellows

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

    EXALIS, SOFTWARE VERSION 1.15

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

    MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

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

    MOLECULAR ADSORBENT RECIRCULATING(MARS)

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

    PRISMAFLEX

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

    SPECTACLE PRESCRIPTION LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PHOENIX HEMODIALYSIS DELIVERY SYSTEM

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

    MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

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

    GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

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

    GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

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

    PRISMAFLEX SYSTEM 7.10

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

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

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

    PRISMAFLEX M150 SET

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

    GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

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

    REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

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

    GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

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

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE