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

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    SIRECUST MODEL 960 AND 961 PATIENT MONITORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COMPLEMENT C3 NEPHELOMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 13, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 14, 2010

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 13, 2012

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024