BEUDAMED
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    MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209128945·

    TREPCHEK TREPONEMAL ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SKYLINE 55

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMS·Product code GEX·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025