BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SILICONE BLOCKS

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

    FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OXYGEN CONCENTRATION INDICATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    CORE IMPACTION DRILL

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

    TRAUMA STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 29, 2010

    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