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

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    CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI

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

    TURBINATE NASAL SPLINT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LATEX EXAM/SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RELIEVA SPIN SINUPLASTY SYSTEM

    FDA Adverse Event
    Injury ·ACCLARENT, INC.·Product code LRC·January 15, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    QUICKSITE LV

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023