BEUDAMED
    7 results · 35ms · Sources: EU EUDAMED, US FDA

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    PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ULTRASOUND SCANNER PRO FOCUS 2202

    FDA 510(k)
    FDA Class 2 ·Radiology

    CEMSTOP CEMENT RESTRICTOR

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

    CERVIOS TRIAL-IMPL CURVED SIZ 5 GOLD

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWP·January 29, 2013

    OR SOLUTIONS

    FDA Adverse Event
    Malfunction ·O.R. SOLUTIONS, INC.·Product code KKX·December 14, 2010

    SOFTCLIX ® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 14, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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