BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    GEMINI OPHTHALMIC SURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523154029·Tesera X Angled Trial, 60mm x 18mm x 8mm x 0°

    SONOLITH I-MOVE

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

    ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 1, 2010

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 11, 2013

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    VITEK® 2 AST-P626 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 13, 2018

    VITEK® 2 AST-P626 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 13, 2018

    VITEK® 2 AST-P626 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 12, 2018

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025