BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    I/A HANDPIECE WITH REPLACEABLE TIPS

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517390516·CoRoent® XL Wide, 10x22x45mm

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909102452·REVELATION DIAMOND 909-031C - 5 PACK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756349444·TOTAL KNEE PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110881·TIP GUARDS VENTED RED PACK OF 100

    Xsert Lumbar Expandable Interbody System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697X09209102451·9mm-13mm x 10mm x 24mm x 5° PLIF ASSY

    Xsert Lumbar Expandable Interbody System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697X0920910245STR1·9mm-13mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)

    UNITED UTF STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVHEAL SCAR MANAGEMENT DRESSING

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

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 11, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·November 18, 2010

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·July 2, 2014

    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·July 30, 2014