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

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    SURGICAL SAW BLADES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450297544·

    PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    ZOLL PROPAQ MD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·January 8, 2013

    FOUNDATION KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·November 2, 2010

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·July 3, 2014

    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