BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    SILICONE ELASTOMER SHEETING

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERILE SURGICAL SCRUB BRUSH

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

    COREIMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·January 17, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 3, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021