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

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    BRAIDED POLYESTER SUTURE MATERIAL

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

    SMARTSTEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

    FDA 510(k)
    FDA Unclassified ·Unknown

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    PROXIAMAL FEMORAL NAIL ANTIROTATION-II BLADE L90 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HSB·January 18, 2013

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 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