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

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    DIA REPTIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Pixie Pulse (SM9068)

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·May 30, 2014

    W2.0MM IMF SCREW SELF-DRILLING 12MM

    FDA Adverse Event
    Malfunction ·Product code DZL·October 23, 2012

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 22, 2010

    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025