BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    CONNEXUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074195421·PROXIMAL SCREW 6.5 X 90, TI

    RMO

    FDA UDI
    Rmo, Inc.·00885797100085·QUAD HELIX ASST 5

    CT LUCIA

    FDA UDI
    CARL ZEISS MEDITEC PRODUCTION, LLC·00843045101116·3-piece, monofocal, hydrophobic, acrylic, intra...

    SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    4.5MM TI CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Malfunction ·SYNTHES GRENCHEN·Product code HWC·May 22, 2017

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·April 10, 2013

    EXPRESS SD BILIARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·April 12, 2011

    ATLAS + DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 27, 2008

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 2, 2018

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.

    FDA Recall
    Terminated ·Theken Spine Llc·Product code KWQ·July 29, 2010