BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    CARDIAC CARE Q/C TEST KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111298561·JACKSON TRACH TUBE #3-4 PIECE

    NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code FZP·September 12, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021