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

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    CALCULATOR, ENZYME, TURNER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515200005·Phalangeal Elevator, 3mm wide blade, 6"

    SafeSept Transseptal Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPUS SMARTSTITCH SUTURE DEVICE

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

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 24, 2014

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2007

    JOURNEY¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·October 3, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022