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

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    CUSTOM TRAYS, KITS

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

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198024·AK3 PS-C Insert Trial Size 6, 10mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867201804·DEPTH DEVICE, CANNULATED LONG, 6.7MM

    PERRY SUTURING SET W/ANESTHETIC

    FDA 510(k)

    LASER LENS-VARIOUS MODELS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 4, 2010

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·December 27, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016