BEUDAMED
    18 results · 36ms · Sources: EU EUDAMED, US FDA

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    PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPOSIX

    FDA UDI
    Davol Inc.·00801741031212·Composix E/X Mesh, 8" x 10" (20.3 cm x 25.4 cm)...

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331136603·knife handle #9, extra fine, for blades 10-15c,...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180515525·Osteotome, Straight, 10mm

    iTotal Identity 3DP Porous Knee

    FDA UDI
    Restor3d, Inc.·00840097515120·iTotal Identity 3DP Porous Round Patella 38mm x...

    CASCADIA™ Interbody System

    FDA UDI
    VB Spine LLC·10888857554641·Trial Size 14x18x15 mm, Convex

    KJ SUBMERGED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 19, 2008

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 16, 2018

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 22, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 14, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 15, 2008

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 19, 2008

    MESH - COMPOSIX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 19, 2008

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 23, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025