BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    3M NO STING BARRIER FILM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128618·Revision Fluted Offset Stem 10mm x 100mm x 4mm

    Zuma

    FDA UDI
    Seaspine Orthopedics Corporation·10889981096342·Impactor

    CIRIBART GYUDUBG CATGETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AAHS HEARING AID

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

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 11, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 10, 2014

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

    FDA Enforcement
    Class II ·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020

    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