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

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    MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526781733·LUMBAMED FACET 3 POINT SILVER VI

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228702161·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556703646·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...

    VARI-LASE BRIGHT TIP FIBER

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

    Flexitouch System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 12, 2014

    OMNISPAN MENISCAL FASTENER

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·October 11, 2010

    CARPENTIER-EDWARDS® BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 12, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024