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

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    OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYMACON

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

    ENPATH

    FDA Adverse Event
    Injury ·EXTERNAL MANUFACTURER·Product code NHW·April 6, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 12, 2008

    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017